Cell Tissue Bank DOI 10.1007/s10561-013-9386-9
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ORIGINAL PAPER
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Shaila V. Kothiwale
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Received: 1 February 2013 / Accepted: 24 June 2013 Ó Springer Science+Business Media Dordrecht 2013
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Abstract Periodontal regenerative therapy is aimed at reconstruction of lost or injured tissues in such a way that the architecture and function of lost tissues are completely restored. Melcher (J Periodontol 47(5): 256–260, 1976) introduced the concept of guided tissue regeneration (GTR) for osseous reconstructive surgery. The aim of the present innovative clinical and radiographic study was to evaluate the effect of chorionic membrane (CM) in GTR in periodontal pocket therapy. Ten patients with moderate to severe periodontitis were selected in the single blind randomized controlled clinical trial. Patients were treated with periodontal pocket therapy along with CM in study sites and the control sites were treated with periodontal pocket therapy alone. The clinical parameters were recorded at baseline and 12 months. The radiographic parameters were recorded at baseline, 6 and 12 months. Clinical parameters included gingival index (GI), plaque index (PI), pocket probing depth (PPD) and relative attachment level (RAL). Digital images were analysed for bone gain (BG) and density. Data were evaluated using t test. Statistical significant differences were found in both sites at 12 months for GI, PI, PPD and RAL. Highly significant reduction was seen in GI 0.40 ± 0.08 (p = 0.0001), PI (0.41 ± 0.18), PPD 2.50 ± 0.53 mm (p = 0.0431) and increased BG
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S. V. Kothiwale (&) Department of Periodontics, K.L.E.V.K. Institute of Dental Sciences, KLE University, Belgaum, India e-mail:
[email protected]
0.86 ± 0.18 (p \ 0.0001) were observed in study sites. This shows that CM when used with pocket therapy can have influence on clinical parameters. Radiographic findings from this study demonstrated significant BG and density in sites treated with CM as compared to control sites.
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Keywords Periodontal pocket therapy Chorionic membrane Guided tissue regeneration Bone gain Regenerative periodontal therapy
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The evaluation of chorionic membrane in guided tissue regeneration for periodontal pocket therapy: a clinical and radiographic study
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Introduction
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Periodontitis is a globally prevalent inflammatory disease characterized by periodontal tissue destruction. The main purpose of periodontal treatment is to eliminate inflammatory processes in order to arrest the progression of the disease and keep the dentition in a state of the health (Cortellini et al. 1993). Thus the ultimate goal of periodontal therapy is to prevent further attachment loss and predictably restore the periodontal supporting structures that were lost because of disease or trauma in a way that the architecture and function of the lost structures can be re-established. Successful periodontal regeneration relies on the re-formation of an epithelial seal, deposition of new acellular extrinsic fiber cementum and insertion of functionally oriented connective tissue fibers into the root surface, and restoration of alveolar
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the chorionic membrane (CM) a foetal membrane is a biomaterial that can be easily obtained, processed and transported. The study was carried out with the concept of the GTR in periodontal pocket therapy. This was the foremost innovative study to use CM as a barrier membrane for the periodontal pocket therapy. Hence, the aim of the present clinical and radiographic study is to evaluate the effect of GTR using CM in the periodontal pocket therapy.
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Materials and methods
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Ten patients, 6 males and 4 females (25–55 years old; mean age 38.2 years) with moderate to severe periodontitis were selected in the single blind randomized controlled clinical trial. It was a split-mouth design study. The ethical clearance was obtained from the institutional ethical committee. The informed consent was taken from patients after explaining the procedure in their own language. No patients had any contraindications to periodontal surgery. The inclusion criteria were: (1) patients in good systemic health; (2) no use of drugs such as antibiotics, corticoids, chemotherapeutics or immunological modulators that might alter the expected response of the oral tissues; (3) no use of protective or orthodontic apparatus; (4) no smoking; (5) at least 2 mm of keratinized tissue; (6) probing depth C5 mm bilaterally; (7) radiographic evidence of bone loss; (8) compliance with maintenance programme.
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Clinical data
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Following selection, clinical data included gingival index (GI), plaque index (PI), pocket probing depth (PPD) and relative attachment level (RAL) were collected at the baseline (before surgery) and 12 months post surgery. The PI and GI were recorded according the criteria described by Sillness and Loe (1963) and Loe and Sillness (1964) respectively. The RAL and PPD were assessed using a pressure sensitive probe from the gingival margin to the base of the pocket. Radiovisiograph (RVG) was taken at the baseline (before surgery), 6 and 12 months post surgery using paralleling technique. Patients who participated in the study initial therapy was performed, consisting of scaling and root planning. The prematurities, caries and overhangs were
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bone height (Caton and Greenstein 1998). The concept that the cells that repopulate the exposed root surface after periodontal surgery define the nature of the attachment that will form was extensively investigated (Melcher 1976; Gottlow et al. 1984). Conventional periodontal therapies (including scaling, root planing and periodontal surgery) can arrest the disease process. However, healing occurs by a long junctional epithelium forming an attachment to the root surface, a process known as periodontal repair. The ‘‘repair’’ means the restoration of tissue continuity without its original architecture or function. This long epithelial attachment is less desirable because it eventually may lead to epithelial splitting and formation of a deep crevice (Ishikawa et al. 2009). Gingival connective tissue cells can also populate the space adjacent to the denuded root surface after conventional periodontal treatment. Repopulation of the exposed root surface by gingival connective tissue cells is speculated to result in the formation of a connective tissue attachment followed by root resorption. Based on this speculation, Nyman et al. (1982), suggested the placement of a physical barrier between the flap and the root surface to exclude gingival connective tissue and epithelium from the healing process, giving the periodontal ligament cells the opportunity to repopulate the coagulum on the root surface. This technique was named guided tissue regeneration (GTR) favouring the formation of a new periodontal attachment. The barrier membranes recommended for use in GTR, regardless of the material used, must be safe, biocompatible, non-toxic, not induce any inflammatory response, and be designed for clinical applicability based on the morphology of the osseous defects (Gottlow 1982). The barrier function must be maintained for a period sufficient to guide the tissue regeneration, preferably without creating gingival recession (Scantlebury 1993). One of the oldest biomaterials used for scaffolds is the foetal membrane. The foetal membrane was first used for the transplantation of skin in 1910. It is useful in the management of burns; creation of surgical dressings; as well as reconstruction of oral cavity, bladder and vagina; tympanoplasty; and arthroplasty (Kothiwale and Anuroopa 2009). It has gained importance because of its ability to reduce scarring and inflammation; enhance wound healing; and serve as a scaffold for cell proliferation and differentiation as a result of its antimicrobial properties. In addition,
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Periodontal pocket therapy
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The periodontal pocket therapy was performed with the administration of local anesthesia. Following the incisions a mucoperiosteal flap was reflected and the inner aspects of the flaps were curetted and complete debridement of granulation tissue through scaling and
root planing using curettes was performed. The irrigation was done with normal saline. One quadrant in a patient was randomly selected to be treated with a CM for the study site (Fig. 2). The CM was cut with the proper dimension and was then adapted over the alveolar bone extending from the base of the flap reflection to the alveolar crest (AC), flap was repositioned and sutured by interrupted suture technique. The periodontal dressing was placed. In the control site all surgical procedures were identical except no membrane was placed (Fig. 3). Patients received postoperative instructions and were prescribed antibiotic and analgesics. Patients were instructed to rinse twice daily with 0.2 % chlorhexidine gluconate for 6 weeks. The periodontal dressing and sutures were removed 10 days postsurgery. The patients were recalled at 6 and 12 months postoperatively to evaluate oral hygiene status. At 12 months all the parameters were reassessed.
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Radiographic assessment
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The RVG, a digital radiography system, was used to obtain radiovisiographic images of each site before surgical procedure and at 12 months postoperatively using the parallel cone technique. For this purpose, a RVG 5000 superb CMOS sensor was placed inside disposable polythene sleeve and positioned in the mouth. The radiovisiographic images stored in JPEG format were transferred to RVG software system which had inbuilt densitometric analysis incorporated in greyscale units. The cementoenamel junction (CEJ), the base of the defect (BD) and the AC were located on the image. Using Kodak Software markings were made at CEJ to BD and from CEJ to AC respectively. The distance between the two points were displayed on screen. The depth of the osseous defect was obtained by subtracting the two measurements for pre and postsurgical radiographs. All clinical and radiographic measurements were performed by a single examiner who was blinded to the procedure (Figs. 4, 5).
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Statistical analysis
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The Student t test was used to analyse all parameters between study and control sites and to determine the significance of changes over time. 95 % of confidence interval (CI) was calculated. The significant level was fixed at 0.05 level. SPSS version 12 (trial version) was used to analyse the data.
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treated followed by oral hygiene instructions. After 4–6 weeks following initial therapy, patient were reevaluated for periodontal pocket, RAL and oral hygiene maintenance following which periodontal pocket therapy was performed. Quadrants were divided into study and control sites in a split-mouth design. The study sites were treated by conventional therapy and a bioabsorbable membrane (CM) and the control sites were treated by conventional periodontal therapy alone. All the surgeries were performed by the same operator and the measurements by a blinded examiner. The CM was obtained from, Tata Memorial Hospital Tissue Bank, Mumbai, India. The tissue was dispatched for the clinical use to us from the tissue bank. The processing procedures used are based on the International Atomic Energy Agency (IAEA) recommendations and the Asia Pacific Association of Surgical Tissue Banks (APASTB) standards (Fig. 1). (The placenta was procured under full informed consent from mothers who donate their placenta during delivery. The donors were screened for any history or presence of infection and transmissible diseases. Donor’s blood was tested for HIV, hepatitis B, hepatitis C and VDRL. The chorion was cleaned of blood, pasteurized at 60 °C in saline, treated with 70 % alcohol, washed, lyophilized, packed and sterilized by gamma radiation at a dose of 25 kGy.)
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Fig. 1 Chorionic membrane
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Fig. 2 Study site. a Periodontal pocket therapy flap reflection, b CM placement, c sutures placed, d periodontal pack placed
Fig. 3 Control site. a Periodontal pocket therapy flap reflection, b periodontal pack placed
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Results
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Table 1 show that the cases which had similar clinical readings were selected for the study to reduce bias in clinical outcomes. At the baseline both the groups exhibited no statistical difference in the mean ± SD of GI, PI, PPD and RAL suggesting that though the sites were bilateral in the patients, the baseline values were similar. As shown in Table 2, in the study sites the mean ± SD at the baseline of the GI, PI, PPD
and RAL have reduced at 12 months with p \ 0.0001. This reduction in clinical parameters is due to oral prophylaxis and periodontal pocket therapy. The mean ± SD values of above parameters shows that CM when used with periodontal pocket therapy can have better influence on clinical parameters. As shown in Table 3, the mean ± SD values of GI, PI, PPD and RAL at baseline and 12 months with a p value (p \ 0.0001) indicates highly significant reduction in all clinical parameters. This reduction in
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Fig. 4 Presurgical linear measurement done using RVG software a control site, b study site. (1) cementoenamel junction (CEJ) (2) the base of the defect (BD), (3) alveolar crest (AC) were located on the image
Fig. 5 Postsurgical linear measurement done using RVG software a Control site, b Study site (1) cementoenamel junction (CEJ), (2) the base of the defect (BD), (3) alveolar crest (AC) were located on the image Table 1 Comparison between control and study sites at baseline Control Mean GI
2.43
PI
2.30
PPD
7.60
RAL
9.90
Study
p value
Inference
Table 2 Comparison in study sites at baseline and 12 months Base
12th month
p value
Inference
Mean
SD
Mean
SD
GI
2.32
0.43
0.40
0.08
\0.0001
HS
PI
2.22
0.28
0.41
0.18
\0.0001
HS
NS
PPD
7.60
1.17
2.50
0.53
\0.0001
HS
1.0000
NS
RAL
9.30
0.67
4.30
1.06
\0.0001
HS
0.0739
NS
SD
Mean
SD
0.33
2.32
0.43
0.5286
NS
0.24
2.22
0.28
0.5035
0.84
7.60
1.17
0.74
9.30
0.67
HS highly significant
NS not significant
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scores is due to oral prophylaxis and periodontal pocket therapy in the control sites. Table 4 reveals that at 12 months the study sites showed the GI, PI, PPD was significantly reduced as compared to the control sites. The mean of the bone gain (BG) in the study sites of 1.22 ± 0.35 mm (p \ 0.0001) was highly significant suggesting that the mean BG was higher in study sites. Thus indicating
good clinical outcome with CM used in periodontal pocket therapy. Table 5 shows that at 6 months in control and study sites the mean BG was 0.41 ± 0.12 mm, 0.86 ± 0.18 mm respectively with p \ 0.0001 indicating significant inference. At 12 months the mean BG of control sites 0.58 ± 0.23 mm, study sites 1.22 ± 0.35 mm (p = 0.0001) which was highly significant suggesting that the mean BG was increased in study sites as compared to control sites.
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Base
12th month
p value
Inference
Mean
SD
Mean
SD
GI
2.43
0.33
0.61
0.10
\0.0001
HS
PI
2.30
0.24
0.63
0.19
\0.0001
HS
PPD
7.60
0.84
3.50
1.35
\0.0001
HS
RAL
9.90
0.74
5.20
1.40
\0.0001
HS
HS highly significant
Table 4 Comparison between control and study sites at 12 months
Discussion
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One of the goals in periodontal therapy is to restore periodontal tissues lost through periodontal disease. Regeneration is defined as the process by which architecture and function are completely renewed (American Academy of Periodontology 1992). By this definition, periodontal regeneration would include the formation of a new connective tissue attachment including new cementum and supporting bone. The regeneration of the periodontium is the result of elective
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Control GI
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Table 3 Comparison in control sites at baseline and 12 months
Study
Mean
SD
Mean
0.61
0.10
0.40
0.63
0.19
0.41
PPD
3.50
1.35
2.50
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PI
SD
p value
Inference
0.0001
HS
0.18
0.0155
S
0.53
0.0431
S
RAL
5.20
1.40
4.30
1.06
0.1221
NS
BG
0.58
0.23
1.22
0.35
