Gingival Recession Treatment Using Two Different Surgical Techniques

Root Coverage Using Tunneling Technique of Xenogenic Collagen Matrix vs. Autologous Connective Tissue as a Treatment of Miller Class Two Gingival Recession (RCT Study)

Coronally the advanced flap is considered a predictable treatment of gingival recession but in certain situations, it needs a filler like subperiosteal connective tissue graft (CTG) which is considered as the gold standard treatment approach.

This randomized controlled trial compares the clinical benefits and effectiveness of a xenogenic collagen matrix (mucoderm, botiss, dental, Berlin, Germany) as a filler to the subperiosteal connective tissue graft (CTG).

Study Overview

• Status: Completed
• Conditions: Gingival Recession; Root Planing
• Intervention / Treatment: Procedure: xenogeneic collagen matrix

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assuit, Egypt, 71111111
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• -The selected patients for this study are non-smokers, aged 18-60 years with multiple gingival recession (Miller class 1, or 2.) for more than two adjacent affected teeth with plaque score less than 25%

Exclusion Criteria:

• -Patients with systemic complications, psychological problems, parafunctional habits, or patients presented with Mal-posed teeth, hypermobile teeth, teeth with Miller class 3 gingival recession were excluded from this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: root coverage surgeries using autologous connective tissue for treatment of gingival recession; root coverage surgeries using tunneling technique of autologous connective tissue as a treatment of Miller class two gingival recession	Procedure: xenogeneic collagen matrix; xenogeneic collagen matrix called mucoderm used for root coverage for treatment of gingival recession instead of harvesting from the patients connective tissue
Experimental: root coverage surgeries using xenogenic collagen matrix for treatment of gingival recession; root coverage surgeries using tunneling technique of mucodrm membrane ; xenogeneic collagen matrix as a treatment of Miller class two gingival recession	Procedure: xenogeneic collagen matrix; xenogeneic collagen matrix called mucoderm used for root coverage for treatment of gingival recession instead of harvesting from the patients connective tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The zone of keratinized gingiva	The distance from the tip of the papilla to the mucogingival junction minus the probing depth measured in mm using graduated periodontal probe.	6 months after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal probing depth	measured from the gingival margin to the depth of the gingival sulcus in six sites per tooth and measured in mm.	6 months after the surgery
Clinical attachment loss	measured from the cementoenamel junction to the depth of the sulcus in six sites per tooth and measured in mm.	6 months after the surgery
Gingival recession	The depth measured from the gingival margin to the cementoenamel junction in mm.	6 months after the surgery
Patient satisfaction of the esthetics	measured using the visual analog scale.	6 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: root coverage; mucoderm; connective tissue; grafts
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: FDBSUREC/08042021/FA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No