Xenogenic Collagen Matrix and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recession

Gingival Recession Localized Moderate Clinical Trial

Official title:

Clinical Comparison of Coronally-advanced Flap Plus Xenogeneic Collagen Matrix (Fibro-Gide®) and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recessions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04082130
• Other study ID #: UDDS-Perio-01-2019
• Status: Completed
• Phase: N/A
• Start date: August 25, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: January 2021
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

this study is a Clinical evaluation of using Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) compared to subepithelial connective tissue graft (SCTG) plus coronally advanced flap to treat Miller class I gingival recession. A split-full-split thickness flap will be elevated in the (XCM+CAF) group while it will be an only partial thickness flap in the (SCTG+CAF) group. The sample size will be 15 patients. Each patient has bilateral Miller Class I gingival recessions; and as a split-mouth study design one side will be treated with (SCTG+CAF), while the other will be treated with (XCM+CAF).

Description:

The aim of this study is to clinically compare between the subepithelial connective tissue graft (SCTG) plus coronally advanced flap (CAF) which is defined as the golden standard for the treatment of gingival recessions and Xenogenic collagen matrix (XCM) plus coronally advanced flap (CAF) to treat class I Miller gingival recession. CAF elevation will be done as it described by (De Sanctis & Zucchelli 2007) with modifications in the the control group.The flap will be partially elevated in the (SCTG+CAF) group while it will be a split-full-split thickness flap in the (XCM+CAF) group, and finally the flap will stabilized coronally. Fifteen patients who have bilateral buccal Miller Class I gingival recession defects will be enrolled in this study. These defects will be distributed randomly into two groups: the test group (XCM+CAF) and control group (SCTG+CAF). Clinical parameters will be evaluated: Recession depth (REC), change in visible plaque index, recession width (RW), width of keratinized tissue (KT), thickness of gingival tissue (GT), probing depth (PD), clinical attachment level (CAL), healing index (HI), questionnaires will be given to evaluate each of patient perceptions, pain index (PI), and changes in root sensitivity by using visual analog scale (VAS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 1, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 47 Years

Eligibility

Inclusion Criteria:

• Good general health.

• No contraindications for periodontal surgery.

• Presence of one localized gingival recession in each side of the maxilla and/or mandible, All recessions will be Class I defects (Miller 1985).

• The cemento-enamel junction (CEJ) is visible in the defective teeth.

• All patients demonstrating good plaque control.

• No previous periodontal surgery in the targeted area.

Exclusion Criteria:

• Smokers.

• pregnant or nursing patients.

• history of malignancy, radiotherapy, or chemotherapy.

• Patients taking medications that affect mucosal healing.

• Patients with allergy to collagen.

• Previous participation in a clinical trial.

• Type-1 diabetes patients.

• Patient who have diseases that affect connective tissue metabolism.

Related Conditions & MeSH terms

• Gingival Recession
• Gingival Recession Localized Moderate

Intervention

Procedure:
• (XCM)+(CAF)
The description of this intervention has been already given before.
• (SCTG)+(CAF)
The description of this intervention has been already given before.

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Periodontics, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (12)

Chambrone L, de Castro Pinto RCN, Chambrone LA. The concepts of evidence-based periodontal plastic surgery: Application of the principles of evidence-based dentistry for the treatment of recession-type defects. Periodontol 2000. 2019 Feb;79(1):81-106. doi: 10.1111/prd.12248. Review. — View Citation

de Sanctis M, Zucchelli G. Coronally advanced flap: a modified surgical approach for isolated recession-type defects: three-year results. J Clin Periodontol. 2007 Mar;34(3):262-8. — View Citation

Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennström J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10. — View Citation

Jepsen K, Stefanini M, Sanz M, Zucchelli G, Jepsen S. Long-Term Stability of Root Coverage by Coronally Advanced Flap Procedures. J Periodontol. 2017 Jul;88(7):626-633. doi: 10.1902/jop.2017.160767. Epub 2017 Mar 17. — View Citation

Kim HJ, Chang H, Kim S, Seol YJ, Kim HI. Periodontal biotype modification using a volume-stable collagen matrix and autogenous subepithelial connective tissue graft for the treatment of gingival recession: a case series. J Periodontal Implant Sci. 2018 Dec 27;48(6):395-404. doi: 10.5051/jpis.2018.48.6.395. eCollection 2018 Dec. — View Citation

Lafzi A, Abolfazli N, Faramarzi M, Eyvazi M, Eskandari A, Salehsaber F. Clinical comparison of coronally-advanced flap plus amniotic membrane or subepithelial connective tissue in the treatment of Miller's class I and II gingival recessions: A split-mouth study. J Dent Res Dent Clin Dent Prospects. 2016;10(3):162-8. doi: 10.15171/joddd.2016.026. Epub 2016 Aug 17. — View Citation

Matoh U, Petelin M, Gašperšic R. Split-Mouth Comparison of Coronally Advanced Flap with Connective Tissue Graft or Collagen Matrix for Treatment of Isolated Gingival Recessions. Int J Periodontics Restorative Dent. 2019 May/Jun;39(3):439-446. doi: 10.11607/prd.3562. — View Citation

Rasperini G, Acunzo R, Pellegrini G, Pagni G, Tonetti M, Pini Prato GP, Cortellini P. Predictor factors for long-term outcomes stability of coronally advanced flap with or without connective tissue graft in the treatment of single maxillary gingival recessions: 9 years results of a randomized controlled clinical trial. J Clin Periodontol. 2018 Sep;45(9):1107-1117. doi: 10.1111/jcpe.12932. Epub 2018 Aug 20. — View Citation

Stefanini M, Jepsen K, de Sanctis M, Baldini N, Greven B, Heinz B, Wennström J, Cassel B, Vignoletti F, Sanz M, Jepsen S, Zucchelli G. Patient-reported outcomes and aesthetic evaluation of root coverage procedures: a 12-month follow-up of a randomized controlled clinical trial. J Clin Periodontol. 2016 Dec;43(12):1132-1141. doi: 10.1111/jcpe.12626. Epub 2016 Nov 7. — View Citation

Stefanini M, Zucchelli G, Marzadori M, de Sanctis M. Coronally Advanced Flap with Site-Specific Application of Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recessions: A 3-Year Follow-Up Case Series. Int J Periodontics Restorative Dent. 2018 Jan/Feb;38(1):25-33. doi: 10.11607/prd.3438. — View Citation

Tatakis DN, Trombelli L. Gingival recession treatment: guided tissue regeneration with bioabsorbable membrane versus connective tissue graft. J Periodontol. 2000 Feb;71(2):299-307. — View Citation

Zucchelli G, Mele M, Mazzotti C, Marzadori M, Montebugnoli L, De Sanctis M. Coronally advanced flap with and without vertical releasing incisions for the treatment of multiple gingival recessions: a comparative controlled randomized clinical trial. J Periodontol. 2009 Jul;80(7):1083-94. doi: 10.1902/jop.2009.090041. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recession depth (REC): (Change in the amount of root coverage)	from the free gingival margin to the cemento-enamel junction at the mid-buccal aspect. Using University of North Carolina periodontal probe UNC15 (Medesey®-Italy).	1)At baseline, 2) 2 weeks post-surgery, 3) At 1 month post-surgery and 4) 3 months post-surgery.
Secondary	change in visible plaque index:	Score 0 - No plaque; Score 1 - Separate flecks of plaque at the cervical margin of the tooth; Score 2 - A thin continuous band of plaque at the cervical margin of the tooth; Score 3 - A band of plaque wider then 1mm covering less than 1/3rd of the crown of the tooth; Score 4 - Plaque covering at least 1/3rd but less than 2/3rd of the crown of the tooth; Score 5 - Plaque covering 2/3rd or more of the crown of the tooth	1) baseline, 2) at 2 weeks postoperative,3) 1 month and 4) 3 month postoperative
Secondary	Recession width (RW)	at the cemento-enamel junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).	1) at baseline, 2) at 2 weeks postoperative, 3) at 1 month postoperative, 4) and at 3 months postoperative.
Secondary	Width of keratinized tissue (KT)	from the free gingival margin to the mucogingival junction using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).	1) baseline, 2) 2 weeks postoperative, 3) 1 month postoperative and 4) 3 months postoperative.
Secondary	Thickness of gingival tissue (GT)	with an injection needle and a silicon marker, at the mid-buccal aspect below the gingival margin.	1) at baseline, and 2) 3 months postoperative.
Secondary	Probing depth (PD)	the distance between the gingival margin and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).	1) at baseline, 2) and 3 months postoperative.
Secondary	Clinical attachment level (CAL)	distance between the CEJ and the bottom of the pocket measured at the mid-buccal aspect of the tooth using periodontal probe of University of North Carolina UNC15 (Medesey®-Italy).	1) at baseline, 2) at 3 months postoperative.
Secondary	Healing index	score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence.; score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration.; score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.	1) at two weeks following surgery and (2) at one month following surgery.
Secondary	Pain index (PI)	Using Visual Analogue scale (VAS) (2001 Crichton), Patients will be asked to select among 100 scores (0 indicating no pain at all , 50 indicating average pain, and 100 indicating very painful).	1) at 2 hours, 2) 24 hours, 3) 48 hours,4) 72 hours following surgery and 5) at 1-week after surgery.
Secondary	Patient Perceptions	Using 100 cm Visual Analogue Scale (VAS)Patients will be asked to select among 100 scores (0 indicating very bad, 50 indicating average, and 100 indicating excellent results).	at three months post-surgery.
Secondary	Change in root sensitivity	Using a 100 cm-visual analog scale (VAS), patients' root sensitivity will be recorded with zero indicating no pain or sensitivity, 50 indicating moderate pain or sensitivity and 100 indicating worst pain or sensitivity possible.	1) at baseline, 2) and at 3 months postoperative.