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 Table of Contents  
ORIGINAL ARTICLE
Year : 2019  |  Volume : 9  |  Issue : 2  |  Page : 70-76

Clinical evaluation of oily calcium hydroxide suspension alone and in combination with β-tricalcium phosphate in the treatment of periodontal intrabony defects


1 Department of Dentistry, GMERS Medical College and Hospital, Valsad, Gujarat, India
2 Department of Periodontics, Bangalore Institute of Dental Sciences, Bengaluru, Karnataka, India
3 Department of Periodontics, Government Dental College and Research Institute, Bengaluru, Karnataka, India

Date of Submission19-Apr-2019
Date of Decision16-Dec-2019
Date of Acceptance07-Jan-2020
Date of Web Publication3-Feb-2020

Correspondence Address:
Dr. Ankur G Shah
Department of Dentistry, GMERS Medical College and Hospital, Halar Road, Nanakwada, Valsad - 396 001 Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijmd.ijmd_27_19

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  Abstract 


Background: An oily calcium hydroxide suspension (OCHS) has been proved to be efficient in promoting bone regeneration in periodontal intrabony defects. However, the outcome of regenerative therapy using an OCHS as an adjunct to open-flap debridement is believed to be compromised by its low consistency. Thus, the present study was carried out to evaluate an OCHS alone and in combination with β-tricalcium phosphate (β-TCP) as a bone graft material in the treatment of periodontal intrabony defects.
Materials and Methods: Twenty-six intrabony defects in 10 patients were divided into experimental and control sites. The experimental sites were debrided and grafted with a combination of OCHS and β-TCP. The control sites were debrided and grafted with OCHS alone. Probing pocket depth (PPD), clinical attachment level (CAL), and gingival margin position were recorded at baseline and at 3, 6, and 9 months.
Results: No differences in any of the investigated parameters were observed at the baseline between the two groups. At 9 months postoperatively, the experimental group showed a reduction in mean PPD from 7.56 ± 1.15 to 4.19 ± 1.42 mm (P < 0.001) and a change in mean CAL from 8.00 ± 1.67 to 5.06 ± 2.17 mm (P < 0.001). In the control group, the mean PPD reduced from 7.90 ± 1.10 to 5.90 ± 1.52 mm (P < 0.05) and the mean CAL changed from 8.30 ± 1.16 to 6.40 ± 1.35 mm (P < 0.05). The experimental group demonstrated significantly higher PPD reduction and CAL gain than control group. Changes in the gingival margin position were nonsignificant in both the groups.
Conclusion: Overall, both therapies led to significant PPD reduction and CAL gain. The combination of an OCHS and β-TCP as a bone graft material was more effective in terms of improving clinical parameters than OCHS alone.

Keywords: Bone graft material; intrabony defect; oily calcium hydroxide suspension; periodontal regeneration; β-tricalcium phosphate


How to cite this article:
Shah AG, Prabhu K S, Janitha S. Clinical evaluation of oily calcium hydroxide suspension alone and in combination with β-tricalcium phosphate in the treatment of periodontal intrabony defects. Indian J Multidiscip Dent 2019;9:70-6

How to cite this URL:
Shah AG, Prabhu K S, Janitha S. Clinical evaluation of oily calcium hydroxide suspension alone and in combination with β-tricalcium phosphate in the treatment of periodontal intrabony defects. Indian J Multidiscip Dent [serial online] 2019 [cited 2020 Mar 29];9:70-6. Available from: http://www.ijmdent.com/text.asp?2019/9/2/70/277448




  Introduction Top


Periodontal disease is a bacterial infection that results in destruction of the supporting structures of the teeth, ultimately leading to tooth loss.[1] As a consequence of the disease process, vertical bone defects adjacent to roots frequently occur, resulting in areas that are difficult for access, root debridement, and maintenance of effective plaque control.[2] Left untreated, these defects can provide a potential harbor for the reestablishment of pathogenic microflora. Thus to facilitate long-term management of a healthy dentition, the periodontal defects must be eliminated. Therapeutic approaches for correcting these anatomic defects include procedures such as open-flap debridement, resective procedures, and periodontal regenerative therapy.[3] In recent years, there has been a shift in the therapeutic concept from the resection to the regeneration, and this has significantly impacted the practice of periodontology.

Periodontal regeneration has been reported following a variety of surgical approaches involving root surface biomodification, often combined with coronally advanced flap procedures, the placement of bone grafts or bone substitutes, and organic or synthetic barrier membranes.[4],[5]

Bone grafts, both autogenous and allogenic, are essential if restoration of the lost bone accompanied by a functional attachment apparatus is to be achieved. Autogenous grafts are considered as a gold standard among graft materials because they are superior at retaining cell viability, they contain osteoblasts and osteoprogenitor stem cells and heal by osteogenesis, and they avoid the potential problems of histocompatibility differences and risk of disease transfer. However, its availability is limited. In addition, it always requires a secondary surgical procedure with all its risks. Alloplastic graft material, on the other hand, appears to act as biologic fillers, resulting in connective tissue encapsulation of the graft particles and little or no new bone formation.[6]

Results of basic research and clinical studies have proven the influence of an oily calcium hydroxide suspension (OCHS) on bone regeneration in closed defects subsequent to periapical surgeries, in bone cysts and post extraction alveoli.[7] Histological and radiological analyses, both in animals and humans, seem to indicate a predictable regeneration of closed bone defects.[8] Such results recently led to attempts to use the OCHS, alone or under various combinations, in treating periodontal defects. However, since the OCHS material has a low consistency, it cannot ensure sufficient stability of the mucoperiosteal flap when used alone. To overcome such situations, the combination of the OCHS with a bone replacement material could offer a convenient solution. By this approach, the chemical and biological properties of the OCHS could be combined with the mechanical properties of the bone replacement material. In this combination, the OCHS could enhance the bone and the periodontal healing, while the bone replacement material could avoid the collapse of the mucoperiosteal flaps and ensure the postsurgical stability of the wound. Tricalcium phosphate (TCP) is a highly purified, multicrystalloid porous form of the calcium phosphate. The healing of the periodontal wound occurs with bone in growth in the pores of the TCP.[9],[10] The combination of mechanical properties of the TCP with the biologic and chemical features of OCHS could be both of biologic and clinical interest.

The major objective of this study was to evaluate the efficacy of OCHS alone or in combination with β-TCP as a bone graft material in the treatment of human periodontal intrabony defects.


  Materials and Methods Top


This was a split-mouth randomized controlled trial. The study design was approved by the institutional review committee for human subjects and the study was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2000. Ten patients (3 males and 7 females) with a total of 26 intrabony defects were selected for the study. In patients with more than two intrabony defects in different quadrants, one defect was randomly allotted to the control group and the rest of the defects were assigned to the experimental group. None of the patients had experimental and control sites or two experimental sites in the same quadrant. Thus, we had 16 experimental sites and 10 control sites. Randomization was performed by lottery through envelopes. All patients who belonged to 20–40 years of age group had CAL loss of ≥6 mm and showed radiographic evidence of periodontal osseous defects. Smokers, pregnant/lactating women, and medically compromised patients were excluded from the study. All selected patients underwent phase I periodontal therapy 1 month prior to the surgery. All patients were instructed and motivated to maintain a good oral hygiene level, verified by a reduction of the plague index (Silness and Loe) <1. Selective grinding in cases with traumatic occlusion was considered.

The following clinical parameters were recorded at the baseline and at 3, 6, and 9 months postoperatively: probing pocket depth (PPD), clinical attachment level (CAL), and gingival margin position. All the measurements were standardized using customized acrylic stents with grooves, which were prepared on the study model of the patients [Figure 1]. The recordings were made using a periodontal probe (PCP-UNC 15®, Hu-Friedy, Chicago, IL, USA). Radiographic measurement included intraoral periapical and digital radiographs of each defect site at the baseline and all follow-up visits using long-cone/paralleling technique. Four to 6 weeks after phase I therapy, the patients were subjected to surgical procedure.
Figure 1: Experimental site grafted with a combination of oily calcium hydroxide suspension and β-tricalcium phosphate

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Following preprocedural rinse with 0.2% chlorhexidine digluconate, local anesthesia was obtained using 2% lignocaine with adrenaline 1:80,000. A full-thickness flap was raised after intrasulcular incision, without using releasing incisions. After removal of the granulation tissue, the exposed roots underwent thorough SRP. In the experimental group, defects were filled with a combination of OCHS (Osteoinductal®, Osteoinductal GmbH, Munich, Germany) and pure phase β-TCP (Cerasorb®, Curasan Pharma GmbH, Kleinostheim, Germany) bone graft material [Figure 1]. The required quantity of both the graft materials was transferred from the syringe/vial to the dappen dish and mixed to a homogeneous mixture. When it became a cohesive mass, it was delivered into the vertical defect in small increments to the level of the remaining bony walls. The defects assigned to the control group were filled with OCHS bone graft material alone [Figure 2].
Figure 2: Control site grafted with combination of only oily calcium hydroxide suspension

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Flaps were then repositioned and secured in place using 3-0 black braided silk, and interrupted sutures were placed to obtain primary closure. The surgical areas were protected with a noneugenol dressing (Coe-pak, GC America Inc., Alsip, IL, USA). All patients were prescribed systemic doxycycline HCL 200 mg for the first day followed by 100 mg/day for another 6 days along with a combination of ibuprofen 400 mg and paracetamol 325 mg given twice daily for 3 days. Postoperative instructions were given to all the patients and they were instructed to report to the department after 24 h of surgery and then after 10 days. After 10 days, periodontal dressing was removed and the surgical area was evaluated for any signs of inflammation, infection, or allergy.


  Results Top


Experimental and control group included 16 and 10 intrabony defects, respectively. All patients showed good compliance and the healing period was uneventful for both the treated groups, without any signs of inflammation, infection, and swelling, indicating the biocompatibility of OCHS when used alone or in combination with β-TCP. There was no statistically significant difference between experimental and control groups in terms of any of the clinical parameters at the baseline (data not shown). The mean PPD (±standard deviation) in the experimental group was 7.56 ± 1.15 mm at baseline, 5.44 ± 1.20 mm at 3 months, 4.56 ± 1.45 mm at 6 months, and 4.19 ± 1.42 mm at 9 months. These changes in PPD when compared to baseline were significant at 3, 6, and 9 months postoperatively (P < 0.001) [Figure 3] and [Figure 4]. The control group also showed a statistically significant reduction in PPD at 3 (6.40 ± 1.50 mm), 6 (6.10 ± 1.37 mm), and 9 (5.90 ± 1.52 mm) months postoperatively when compared to the baseline (7.90 ± 1.10 mm) [Table 1] and [Figure 5], [Figure 6]. The mean PPD measurements were significantly less in the experimental group as compared to the control group at 6 (P = 0.013) and 9 (P = 0.008) months postoperatively [Table 2].
Figure 3: Measurement of probing pocket depth at baseline at experimental site

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Figure 4: Measurement of probing pocket depth 9 months postoperatively at experimental site

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Table 1: Comparison of changes in mean probing pocket depth measurements in experimental and control groups at different visits

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Figure 5: Measurement of probing pocket depth at baseline at control site

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Figure 6: Measurement of probing pocket depth 9 months postoperatively at control site

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Table 2: Comparison of changes in mean probing pocket depth measurements between experimental and control group at different visits

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The mean CAL measurements in the experimental group changed from 8.00 ± 1.67 mm at the baseline to 6.12 ± 1.99 mm at 3 months, 5.44 ± 2.25 at 6 months, and 5.06 ± 2.17 at 9 months postoperatively. These changes were statistically significant (P < 0.05). The control group also showed a statistically significant CAL gain at all recall visits compared to the baseline (P < 0.05) [Table 3]. The comparison between experimental and control groups revealed significantly greater CAL gain in the experimental group (5.06 ± 2.17) than in the control group (6.40 ± 1.35) at 9 months postoperatively (P < 0.05) [Table 4].
Table 3: Comparison of changes in mean clinical attachment level measurements in experimental and control groups at different visits

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Table 4: Comparison of changes in mean clinical attachment level measurements between experimental and control group at different visits

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The intragroup and intergroup comparison of changes in the gingival margin position found to be statistically nonsignificant (P > 0.05) [Table 5] and [Table 6].
Table 5: Comparison of changes in mean gingival margin position measurements in experimental and control groups at different visits

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Table 6: Comparison of changes in mean gingival margin position measurements between experimental and control group at different visits

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This study was not designed to statistically evaluate radiographic findings. However, both the experimental and control sites demonstrated a considerable amount of bone fill radiographically at postoperative visits when compared to preoperative radiographs [Figure 7], [Figure 8], [Figure 9], [Figure 10].
Figure 7: Preoperative intraoral radiograph of experimental site with grid

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Figure 8: 9-month postoperative radiograph of experimental site with grid

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Figure 9: Preoperative intraoral radiograph of control site with grid

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Figure 10: 9-month postoperative radiograph of control site with grid

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Statistical analysis

Data analysis was performed with Statistical Package for the Social Sciences 11.0 for Windows (SPSS Inc., Chicago, IL, USA). The Student's t- test was used to determine whether there was a statistical difference between experimental and control groups in the parameters measured. One-way analysis of variance (ANOVA) was used to test the difference between the groups. In the entire above tests, P < 0.05 was accepted as indicating statistical significance.


  Discussion Top


We found that the treatment of intrabony defects with OCHS either alone or in combination with β-TCP led to a clinically and statistically significant reduction of PPD and gain in CAL. The additional application of β-TCP showed clear superiority to treatment with OCHS alone. Till date, there is no controlled study comparing the results of a combination of OCHS and β-TCP with that of an OCHS alone in the treatment of periodontal osseous defects. The present study is based on a case series carried out by Stratul et al.,[11] who treated 14 intrabony defects with a combination of an OCHS and α-TCP; however, the authors did not include a control group in this case series.

Results of basic research and clinical studies have proven the influence of an OCHS on bone regeneration in closed defects subsequent to periapical surgeries, in bone cysts and post extraction alveolae. Its osteostimulative effect seems to rely on many factors such as (i) the deposit action of the Ca (OH)2, which sustains the bone metabolism in a constant, mild alkali environment; (ii) the stimulation of the angiogenic bone growth with concentration of the growth factors next to the defect wall; and (iii) the reduction of the inflammation in the operated site, which enhances the wound healing.[12] In this study, we found that OCHS alone resulted in a statistically significant reduction in PPD and gain in CAL when compared to the baseline. Similar results have been demonstrated in several other studies.[8],[13],[14],[15] On the contrary to these, a recent study evaluating OCHS failed to demonstrate any superior clinical outcomes in comparison with open-flap debridement.[16]

However, low consistency of OCHS graft material may make the postoperative stability of mucoperiosteal flap difficult. Therefore, a collapse of the mucoperiosteal flap cannot be avoided, followed by the reduction of the space necessary for the regeneration process. To overcome such situations, the combination of OCHS with other bone replacement material has been suggested.[11],[17]

β-TCP has a phase purity of 99%, which makes it completely resorbable simultaneous with new vital bone formation within a period of 6–12 months.[18] Thus, β-TCP could be successfully combined with OCHS. In this combination, the OCHS could enhance the bone and the periodontal healing, while β-TCP could avoid the collapse of the mucoperiosteal flaps and ensure the postsurgical stability of the wound. β-TCP has also been combined with enamel matrix proteins to achieve superior clinical outcomes.[19],[20] In the current study, when OCHS was combined with β-TCP, the sites demonstrated a significantly greater reduction in PPD and gain in CAL as compared to those treated with OCHS alone. These findings are in agreement with those reported by Stratul et al.[11],[17]

Radiographic evaluation of the experimental and control sites showed progressive changes in the appearance of the graft material from the time of placement to 3, 6, and 9 months. Well-documented studies using an OCHS alone or in combination with TCP have demonstrated similar results.[8],[11],[13],[17] In the current study, we used radiographic grid as well as long-cone paralleling technique to standardize the radiographs at all recall visits. However, the results of the radiographic evaluation were not subjected to the statistical analysis.

Due to tissue-invading nature of periodontal pathogens such as Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans, mechanical therapy alone may not be sufficient to eliminate these pathogens.[21] Hence, it may be useful to administer antibiotics that will help to eliminate these pathogens. In the present study, we used doxycycline postoperatively for several reasons. First, doxycycline has been reported to substantially reduce or eliminate pathogenic species, especially Gram-negative bacilli.[22] Second, doxycycline is known to exhibit anti-collagenase and anti-inflammatory properties which may result in improved periodontal healing postoperatively.[23]


  Conclusion Top


There was a statistically significant reduction in PPDs and gain in CAL at the experimental as well as control sites when compared to the baseline. There was a greater percentage reduction in PPDs and gain in CAL at the experimental sites, which was statistically significant when compared to the control sites. The experimental sites demonstrated more amount of bone fill as compared to control sites in some cases. The findings of this study concluded that OCHS can be combined with other bone graft material possessing good mechanical properties to attain better clinical outcomes than those of OCHS alone.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Mellonig JT. Autogenous and allogeneic bone grafts in periodontal therapy. Crit Rev Oral Biol Med 1992;3:333-52.  Back to cited text no. 1
    
2.
Aichelmann-Reidy ME, Heath CD, Reynolds MA. Clinical evaluation of calcium sulfate in combination with demineralized freeze-dried bone allograft for the treatment of human intraosseous defects. J Periodontol 2004;75:340-7.  Back to cited text no. 2
    
3.
Kao RT. Periodontal regeneration and reconstructive surgery. In: Rose LF, editor. Periodontics: Medicine, Surgery and Implants. 1st ed. St. Louis: Elsevier Mosby Inc.; 2004. p. 1050-111.  Back to cited text no. 3
    
4.
Bowers GM, Chadroff B, Carnevale R, Mellonig J, Corio R, Emerson J, et al. Histologic evaluation of new attachment apparatus formation in humans. Part II. J Periodontol 1989;60:675-82.  Back to cited text no. 4
    
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Bowers GM, Chadroff B, Carnevale R, Mellonig J, Corio R, Emerson J, et al. Histologic evaluation of new attachment apparatus formation in humans. Part III. J Periodontol 1989;60:683-93.  Back to cited text no. 5
    
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Nasr HF, Aichelmann-Reidy ME, Yukna RA. Bone and bone substitutes. Periodontol 2000 1999;19:74-86.  Back to cited text no. 6
    
7.
Stratul S, Rusu D, Jianu R. Densitometric evaluation of periapical bone healing using an oily calcium hydroxide suspension. A preliminary controlled study. Int Poster J Dent Oral Med 2004;6:236.  Back to cited text no. 7
    
8.
Stratul SI, Schwarz F, Becker J, Willershausen B, Sculean A. Healing of intrabony defects following treatment with an oily calcium hydroxide suspension (Osteoinductal). A controlled clinical study. Clin Oral Investig 2006;10:55-60.  Back to cited text no. 8
    
9.
Stahl SS, Froum S. Histological evaluation of human intraosseous healing responses to the placement of tricalcium phosphate ceramic implants. I. Three to eight months. J Periodontol 1986;57:211-7.  Back to cited text no. 9
    
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Froum S, Stahl SS. Human intraosseous healing responses to the placement of tricalcium phosphate ceramic implants. II. 13 to 18 months. J Periodontol 1987;58:103-9.  Back to cited text no. 10
    
11.
Stratul SI, Willershausen B, Sculean A. Intrabony defects treated with a combination of α-tricalcium phosphate and an oily calcium hydroxide suspension. A case series. TMJ 2004;54:410-6.  Back to cited text no. 11
    
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Stratul SI, Sculean A. The oily calcium hydroxide suspension in bone regeneration. TMJ 2004;54:184-90.  Back to cited text no. 12
    
13.
Stratul SI, Sculean A, Willershausen B. Oily calcium hydroxide suspension vs. flap surgery in treating deep intrabony defects. Int Poster J Dent Oral Med 2005;7:285.  Back to cited text no. 13
    
14.
Stratul SI, Rusu D, Benta A, Willershausen B. Clinical comparison between an oily calcium hydroxide suspension (osteoinductal®) and an enamel matrix protein derivative (emdogain®) for the treatment of intrabony periodontal defects in humans. Int Poster J Dent Oral Med 2005;7:297.  Back to cited text no. 14
    
15.
Stratul SI, Rusu D, Benta A, Willershausen B, Sculean A. 12-months clinical comparison between osteoinductal® and emdogain® for the treatment of intrabony defects. Int Poster J Dent Oral Med 2007;9:348.  Back to cited text no. 15
    
16.
Aparna S, Setty S, Thakur S. Oily calcium hydroxide suspension in the treatment of infrabony periodontal defects: A randomized controlled clinical trial. Quintessence Int 2011;42:835-42.  Back to cited text no. 16
    
17.
Stratul SI, Sculean A. Oily calcium hydroxide suspension and alpha-TCP in treating intrabony defects. Int Poster J Dent Oral Med 2004;6:235.  Back to cited text no. 17
    
18.
Trisi P, Rao W, Rebaudi A, Fiore P. Histologic effect of pure-phase beta-tricalcium phosphate on bone regeneration in human artificial jawbone defects. Int J Periodontics Restorative Dent 2003;23:69-77.  Back to cited text no. 18
    
19.
Bokan I, Bill JS, Schlagenhauf U. Primary flap closure combined with emdogain alone or emdogain and cerasorb in the treatment of intra-bony defects. J Clin Periodontol 2006;33:885-93.  Back to cited text no. 19
    
20.
Döri F, Arweiler N, Gera I, Sculean A. Clinical evaluation of an enamel matrix protein derivative combined with either a natural bone mineral or beta-tricalcium phosphate. J Periodontol 2005;76:2236-43.  Back to cited text no. 20
    
21.
Ambrosini P, Miller N, Briançon S, Gallina S, Penaud J. Clinical and microbiological evaluation of the effectiveness of the Nd: Yap laser for the initial treatment of adult periodontitis. A randomized controlled study. J Clin Periodontol 2005;32:670-6.  Back to cited text no. 21
    
22.
Rao SK, Setty S, Acharya AB, Thakur SL. Efficacy of locally-delivered doxycycline microspheres in chronic localized periodontitis and on Porphyromonas gingivalis. J Investig Clin Dent 2012;3:128-34.  Back to cited text no. 22
    
23.
Golub LM, Wolff M, Roberts S, Lee HM, Leung M, Payonk GS. Treating periodontal diseases by blocking tissue-destructive enzymes. J Am Dent Assoc 1994;125:163-9.  Back to cited text no. 23
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9], [Figure 10]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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