|Year : 2012 | Volume
| Issue : 4 | Page : 239-244
A comparative evaluation of bioresorbable type I collagen membrane with and without fibrin fibronectin sealing system in the treatment of gingival recession: A clinical study
Aparajitha Sunkavalli, K. Raja V Murthy
Department of Periodontics, GITAM Dental College and Hospital, Gandhinagar Campus, Rushikonda, Visakhapatnam, Andhra Pradesh, India
|Date of Web Publication||27-Dec-2012|
Department of Periodontics, GITAM Dental College and Hospital, Gandhinagar Campus, Rushikonda, Visakhapatnam - 530 045, Andhra Pradesh
Source of Support: None, Conflict of Interest: None
Background and Objectives: The purpose of the study was to clinically evaluate and compare the efficacy of type I collagen membrane (BIOMEND REGULAR® ) 1 with and without fibrin fibronectin sealing system (TISSEEL® ) 2 in the treatment of localized gingival recession.
Materials and Methods: The study population consisted of 14 patients with a total of 28 gingival recession defects. The selected gingival recession sites were randomly assigned as either experimental site A (BioMend Regular® ) or experimental site B (BioMend Regular® + Tisseel® ). The clinical parameters including plaque index, gingival index, recession depth, recession width, width of keratinized gingiva, probing depth and clinical attachment level were recorded at baseline and at six months and twelve months post-operatively.
Results: Twelve months follow-up results showed significant improvements in all clinical parameters for both the treatment groups. The recession width and depth were reduced in both the groups - BioMend Regular® and BioMend Regular® + Tisseel® , with mean root coverage of 31.79% and 35.64%, respectively. Furthermore, the width of keratinized gingiva was increased by 2.71 mm and 3.14 mm for experimental site A and experimental site B respectively when baseline values were compared with twelve month post-operative data. On intergroup comparison, the mean difference in different clinical parameters was statistically not significan.
Interpretation and Conclusion: Both groups showed the potential of achieving root coverage; however, on comparison between the two groups, the results obtained of BioMend Regular® with Tisseel® group were slightly better, although statistically not significant.
Keywords: BioMend regular, fibrin fibronectin sealing system, gingival recession, mucogingival surgery, periodontal plastic surgery
|How to cite this article:|
Sunkavalli A, Murthy KV. A comparative evaluation of bioresorbable type I collagen membrane with and without fibrin fibronectin sealing system in the treatment of gingival recession: A clinical study. J NTR Univ Health Sci 2012;1:239-44
|How to cite this URL:|
Sunkavalli A, Murthy KV. A comparative evaluation of bioresorbable type I collagen membrane with and without fibrin fibronectin sealing system in the treatment of gingival recession: A clinical study. J NTR Univ Health Sci [serial online] 2012 [cited 2020 Jul 10];1:239-44. Available from: http://www.jdrntruhs.org/text.asp?2012/1/4/239/105112
| Introduction|| |
Gingival recession is an apical shift of the gingival margin with exposure of the root surface.  This migration of the marginal tissue leads to esthetic concerns, dentine hypersensitivity, root caries and cervical wear.  It is, paradoxically, a common finding in patients with a high standard of oral hygiene, as well as in periodontally untreated populations with poor oral hygiene. , Changing the topography of the marginal soft tissue in order to facilitate plaque control is a common indication for root coverage procedures. 
The regeneration of a new connective tissue attachment to denuded root surface is by allowing the selective coronal regrowth of periodontal ligament cells while excluding the gingival tissues from the root during wound healing by means of a barrier membrane.
After the surgical procedures, for a closer approximation of the tissues onto the tooth surface, either suturing, application of fibrin glues, or cyanoacrylates is preferred.
The purpose of the present clinical study was to evaluate and compare the efficacy of type I collagen membrane (BIOMEND REGULAR® ) with and without fibrin fibronectin sealing system (TISSEEL® ) [Figure 1] in the treatment of localized gingival recession.
| Materials and Methods|| |
A total of 28 sites from 14 patients, with good systemic health, with Miller's Class I or II gingival recession defects measuring ≥ 3mm either on incisors or on cuspids, one in each quadrant or on contra lateral sides of same arch were selected for the study after completion of presurgical phase of the treatment. The selected sites were divided as follows by using split mouth design.
Experimental site A: Fourteen sites were treated with coronally advanced flap following placement of a bioresorbable, Type I collagen membrane - BioMend Regular® [Figure 2].
|Figure 2: Experimental site A (BioMend + Coronally Advanced Flap) (a) Recession depth with periodontal probe and stent, (b) Recession width with periodontal probe and stent, (c) 12 months post-operative view, (d) Horizontal, vertical and crevicular incisions, (e) BioMend membrane placed, (f) Coronally positioned flap sutured|
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Experimental site B: Fourteen sites were treated with coronally advanced flap following the application of fibrin fibronectin sealing system- Tisseel® , which was covered with a bioresorbable type I collagen membrane - BioMend Regular® [Figure 3].
|Figure 3: Experimental site B (Tisseel + BioMend + Coronally Advanced Flap), (a) Recession depth with periodontal probe and stent, (b) Recession width with periodontal probe and stent, (c) 12 months post-operative view, (d) Tisseel application, (e) BioMend membrane placed, (f) Coronally positioned flap sutured|
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Patients unable to perform routine oral hygiene procedures, patients with a history of drug allergy and patients who are known smokers were excluded. Patients were informed, as to the character and purpose of the study and were required to sign an informed consent. The study design was approved by the University Institutional Review Board and patient consent was obtained.
Prior to the surgery, initial preparation procedures, including oral hygiene instructions, scaling and root planing was undertaken. Patients achieved an O'Leary plaque control record compliance level of 10% or less and 0% in the area to be treated.
All the measurements were standardized, using customized acrylic stents with vertical grooves at the defect sites to aid in probe penetration in the same plane every time. The recordings were made by Williams graduated probe.
The apical limit of the groove was used as the fixed reference point for clinical attachment level and gingival recession measurement. The Williams graduated probe was inserted through the groove and markings were made at fixed reference point of the stent.
Plaque index,  gingival index, probing pocket depth,  clinical attachment level (CAL) by using occlusal stent (Clark et al,  gingival recession depth (GR), gingival recession width and width of the keratinized gingiva were recorded at baseline and at 6 months and 12 months post-operatively.
The surgical procedures at both sites were identical, except that in experimental site B there was a fibrin-fibronectin sealing system application (Tisseel® ), apart from the placement of a bioresorbable membrane (BioMend Regular® ).
Following local anesthesia, horizontal incisions were made mesial and distal to the defect, approximately at the level of the cementoenamel junction (CEJ) towards the adjoining tooth, and terminated at least 0.5 mm from the gingival margin of the adjacent teeth. Two oblique releasing incisions were given, starting at the terminal point of the horizontal incisions and extending into the alveolar mucosa. An intrasulcular incision was made connecting the horizontal incisions. A mucoperiosteal flap was elevated at the buccal aspect of the alveolar process, 3 to 4 mm apical to the bone crest. From this point, a partial thickness dissection was performed to allow for coronal positioning of the flap without tension. The root was carefully planned with curettes and rotating instruments. In experimental site B, a 2 to 3 ml film of fibrin/fibronectin sealing system (Tisseel® ) was then placed over the root surface and the surrounding bone margins, and allowed to set.
A custom-made bioresorbable membrane (BioMend Regular® ) was fitted to cover the defect 3 mm apically over the adjacent alveolar crest and at least 1 mm coronally to the CEJ. During the positioning of the membrane, care was taken not to displace or compress the fibrin fibronectin, in order to ensure room for regenerating tissue between the membrane and the root surface.
A similar technique was followed on the experimental site A, except that a bioresorbable membrane (BioMend Regular® ) was adapted to the surgical site without application of the adhesive system. The membrane was held in place by a sling suture.
Patients were instructed to rinse twice daily with 0.12% chlorhexidine gluconate mouth-rinse for 4 weeks. Patients were recalled 24 h after surgery to evaluate signs of post-operative complications. Sutures were removed 10-14 days after surgery. Recall appointments for patients were made for three, six and finally at twelve months. Patients were evaluated clinically and radiographically at six months and twelve months post-operatively.
| Results|| |
Fourteen patients (13 males and 1 female), fulfilling the selection criteria, were selected for the study. Twenty-eight sites in fourteen patients (each patient having identical Miller's class II gingival recession on the contralateral sides) were randomly divided into experimental site A and experimental site B as per split mouth design.
All 14 patients completed the study. Surgical sites, control and experimental, healed uneventfully. No adverse tissue reactions or events were noted. Following collection of data on all patients, a statistical analysis was completed to assess those parameters discussed as primary objectives.
All the clinical parameters recorded were subjected to the following statistical analysis:
- For intra-group variations, paired t-test was performed.
- For comparison between the two groups/inter-group variations unpaired t-test was performed.
Index and Gingival Index: The increase in the mean plaque index and mean gingival index in the two groups, from baseline to six months and reduction from six to twelve months, was statistically highly significant.
Recession Depth - Mid facial [Table 1]: The mean recession depth in experimental site A reduced by 53.19% and 44.68% at six and twelve months post operatively and in experimental site B by 61.54% and 50% at six and twelve months post-operatively, all values being statistically significant.
Recession width [Table 2]: In experimental site A, the mean recession width reduced 32.7% and 18.03% and in experimental site B by 31.5 % and 21.3 % at six and twelve months post-operatively, which was statistically highly significant (P < 0.05).
Width of keratinized gingival (WKG): In experimental site A, mean WKG showed an increase of 2.78% and 5.56% from baseline to six and twelve months respectively, both of which were statistically not significant (P < 0.05). In experimental site B, the mean WKG showed an increase of 5.41% and 18.97% from baseline to six and twelve months, which was statistically not significant at six months and statistically significant at twelve months. Intergroup comparison at twelve months showed statistical significance.
Probing Depth - Mid facial: The mean probing depth reduced 6.67% in experimental site A (from 1.07 mm to 1.00 mm) and 12.5% in experimental site B (from 1.14 mm to 1 mm) from baseline to six and twelve months, which was statistically not significant.
Clinical Attachment Level (CAL) - Mid facial: In experimental site A, the mean CAL showed a reduction of 40.32% and 35.4% from baseline to six and twelve months respectively, which was statistically significant (P < 0.05). In experimental site B, the mean CAL showed a reduction of 47.06% and 39.71% at six and twelve months respectively, which were statistically significant (P < 0.05). Comparison between the two groups showed no statistical significance.
| Discussion|| |
The purpose of this study was to compare clinically, the efficacy of a bioresorbable, type I collagen membrane BioMend Regular® , with and without fibrin fibronectin sealing system TISSEEL® , in the treatment of localized gingival recession. A total of twenty-eight sites in fourteen patients (13 males and one female) were included. The split mouth design was adopted in the present study to exclude the influence of interarch specific characteristics and facilitate a direct comparison of the two groups Hujoel. 
The experimental site A was treated with BioMend Regular® , a type of collagen membrane, whereas the experimental site B was treated with BioMend Regular® and Tisseel® .
The treated sites were followed up for a period of six and twelve months in order to:
- Verify the effectiveness of both treatment procedures in terms of root coverage.
- Estimate the amount of root coverage
Each patient was subjected to recording of the previously mentioned clinical parameters.
In the present study, the mean plaque score showed a raise from baseline to six months, which later declined at twelve months postoperatively in both the groups. These findings were in accordance with the studies conducted by Trombelli et al,  where there was an initial rise in plaque scores followed by some reduction.
There was an initial increase in gingival index score from base line to six months which can be attributed to the corresponding increase in plaque score. These findings were consistent with the studies conducted by Dimitris N, Tatakis and Trombelli. 
Recession depth and recession width are two important clinical parameters in assessing gingival recession treatment. Reduction in these two parameters results in root coverage and improved aesthetics. The mean recession depth and width mid-facially were reduced in both the experimental groups when the recession depth and width were compared between base line and six months and base line and twelve months post-operative values. There was also a statistical significance between six and twelve months post-operatively. However, no statistical significance was observed when the two experimental groups were compared for mean recession depth and for mean recession width. These findings were in accordance with the studies of Romagna-Genon (2001). 
Probing depth is an important parameter in clinical periodontal research. In this study, there was a mean probing depth reduction from baseline, but was not statistically significant when compared between base line and twelve months. On intergroup comparison, the difference in probing depth was not statistically significant. These findings were in accordance with Trombelli et al (1995). 
The clinical attachment level (CAL) is an important clinical parameter in clinical research studies in periodontics. CAL reduction at six and twelve months in both the groups was statistically significant (P < 0.05) but the intragroup comparison showed no statistical significance. The significant reduction at six months and a slight increase from six months to twelve months in both the groups is expected during healing following gingival surgical procedures and is consistent with the studies of Wang et al (2001).
The post-operative gain in the width of keratinized gingiva at six months and twelve months in the two groups is in conformity with the studies performed by Pintippa, Hom-Lay Wang (2001).  The percentage increase in WKG from six months to twelve months in experimental site B was statistically highly significant (P < 0.05). Intergroup P value at twelve months was also statistically highly significant. The increase in WKG in both the groups is also in conformity with the studies of Wennstrom, who also stated that keratinized tissue width does not interfere with gingival health or recession development.
In this randomized clinical study, the mean root coverage was statistically highly significant. There was no statistical significance obtained between both the experimental groups regarding mean root coverage. These findings were in accordance with Harris RJ (2002). 
The predictability of BioMend Regular is excellent.  The main advantages are a) biocompatibility, b) no inflammatory reaction, c) totally resorbed, degraded and eliminated, d) easy to handle, cut, contour and adapt e) maintains desired shape and configuration f) easily secured in place.
TISSEEL, a fibrin glue/sealant, is a biological two component fibrin-fibronectin sealing system(FFSS), which acts by forming a fibrin clot, is able to achieve hemostasis, seal leakages, glue tissue, or support sutures.  FFSS has been previously used in periodontal surgery to fix gingival grafts to recipient sites and to enhance periodontal regeneration in intrabony defects and gingival recessions. 
Fibronectin acts as a root conditioner and sealant thus enhances the regeneration of connective tissue attachment, possibly by increasing interactions between exposed root surface collagen and fibroblasts within the gingival connective tissue. It promotes easy placement and immediate adherence of the membrane, thus making the perioperative and post-operative events less laborious. ,
No post-operative complications other than those considered normal following any surgical procedure on either site were noticed. Also no antigenic reactions were observed in any of the patients, thereby indicating the safety of BioMend Regular® , Tisseel® , and of the human thrombin used for activation of TISSEEL® . Few studies have earlier focused on the utility of BioMend Regular® and more specifically fibrin fibronectin system in the treatment of gingival recession. Hence, the use of these materials in combination with coronally advanced flap represents a novel approach in the mucogingival therapy.
Limitations and recommendations of the present study
- Histological evaluation was not done due to ethical considerations.
- The sample size was limited.
- The study period was short.
Hence, a long term clinical trial, larger sample size, and histologic evaluation is recommended to evaluate the efficacy of type I collagen membrane BioMend Regular® alone or in combination with Tisseel® for the treatment of localized gingival recession.
| Conclusion|| |
Both the modalities (BioMend Regular® and BioMend Regular® + Tisseel® ) are useful and predictable surgical modalities for the treatment of gingival recession.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2]