Clinical trial NCT04082130: Xenogenic Collagen Matrix and Subepithelial Connective Tissue Graft in the Treatment of Gingival Recession
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession Localized Moderate
Keywords: Xenogenic collagen matrix (XCM).
subepithelial connective tissue graft (SCGT).
coronally advanced flap (CAF).
Root coverage.
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: split-mouth design.
Primary purpose: TREATMENT

Brief 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).

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Recession depth (REC): (Change in the amount of root coverage)
timeFrame: 1)At baseline, 2) 2 weeks post-surgery, 3) At 1 month post-surgery and 4) 3 months post-surgery.
Secondary outcomes:
measure: change in visible plaque index:
timeFrame: 1) baseline, 2) at 2 weeks postoperative,3) 1 month and 4) 3 month postoperative
measure: Recession width (RW)
timeFrame: 1) at baseline, 2) at 2 weeks postoperative, 3) at 1 month postoperative, 4) and at 3 months postoperative.
measure: Width of keratinized tissue (KT)
timeFrame: 1) baseline, 2) 2 weeks postoperative, 3) 1 month postoperative and 4) 3 months postoperative.
measure: Thickness of gingival tissue (GT)
timeFrame: 1) at baseline, and 2) 3 months postoperative.
measure: Probing depth (PD)
timeFrame: 1) at baseline, 2) and 3 months postoperative.
measure: Clinical attachment level (CAL)
timeFrame: 1) at baseline, 2) at 3 months postoperative.
measure: Healing index
timeFrame: 1) at two weeks following surgery and (2) at one month following surgery.
measure: Pain index (PI)
timeFrame: 1) at 2 hours, 2) 24 hours, 3) 48 hours,4) 72 hours following surgery and 5) at 1-week after surgery.
measure: Patient Perceptions
timeFrame: at three months post-surgery.
measure: Change in root sensitivity
timeFrame: 1) at baseline, 2) and at 3 months postoperative.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Periodontics, University of Damascus Dental School
Study officials:
affiliation: MSc student in Periodontics, University of Damascus Dental School
name: Noor Alhuda Ewaz Ali, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Periodontics, University of Damascus Dental School
name: Suleiman Dayoub, DDS MSc PhD
role: STUDY_CHAIR
affiliation: Assistant Professor of Periodontics, Academic Staff Member At Wadi International University
name: Mohammad Alharissy, DDS MSc PhD
role: STUDY_DIRECTOR
References:
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.
citation: Matoh U, Petelin M, Gaspersic 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.
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