Growth Factor Enhanced Matrix With Subepithelial Connective Tissue Graft or Collagen Membrane in Treatment of Gingival Recession

Phase 4

Completed

• Conditions: GINGIVAL RECESSION
• Interventions: Procedure: GROUP II; Procedure: GROUPI

• Registration Number: NCT05782751
• Lead Sponsor: Tanta University

Brief Summary

The study aimed to compare, the effectiveness of Growth Factor Enhanced Matrix (GEM 21s) ® combined either with free connective tissue graft or collagen membrane in the treatment of Miller class II gingival recession.

Detailed Description

Materials and Methods: Twenty sites in 10 patients, with class II Miller gingival recession were allocated randomly to be treated by (GEM 21s) ® with free connective tissue graft (groupI) or GEM 21s with collagen membrane (groupII). Plaque index, bleeding on probing, recession width, recession depth, height of keratinized tissue and digital measurements were recorded at baseline, 1, 3 and 6-months'. Probing pocket depth, clinical attachment level, gingival thickness and Radiographic parameters were recorded at baseline and 6 months'. Root coverage percentage were recorded 6 months postoperative and wound healing index were recorded at 1,3 and 6-months' post-operative .

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Study First Submitted: 2023-02-27
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-21
• Last Update Submitted: 2023-03-21
• Study First Posted: 2023-03-24
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• lack of any related medical issues that contraindicate periodontal surgery,
• optimum adherence as confirmed by a positive attitude towards oral hygiene, and successfully showing up for treatment appointments.
• No history of any medications in the previous six months that may interfere with periodontal surgery Gingival thickness for the selected sites should be > 1mm (as measured 2mm apical to gingival margin),
• Clinical attachment level ≥ 4mm measured from cemento-enamel junction till the deepest probing depth.

Exclusion Criteria

• the presence of class V caries or restoration in the site to be treated,
• previous mucogingival surgery at the selected site.
• Teeth that are tilted, rotated, or have any occlusal abnormalities.
• Smokers and pregnant patients were excluded from the participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(groupII)	GROUP II	10 recession sites GEM 21s with collagen membrane
(groupI)	GROUPI	10 recession sites treated by (GEM 21s) ® with free connective tissue graft

Primary Outcome Measures

Name	Time	Method
Gingival thickness (Gingival biotype)	up to 6 months	measured at mid-buccal area 2 mm apical to the free gingival margin measured at baseline, and 6 months postoperatively
Recession width	up to 6 months	the distance between the mesial and distal papillae along the CEJ measured at baseline , 1, 3, and 6 months
radiographic measurements of facial bone level, thickness and density	up to 6 months	from cone beam CT radiography measured at baseline, and 6 months postoperative
Percentage of root coverage	up to 6 months	according to the following formula: (RD at baseline - RD at 6 months) / RD at baseline)x100 was calculated after 6 months
recession depth	up to 6 months	The distance between the CEJ and the gingival margin at the midbuccal aspect of the involved tooth measured at baseline , 1, 3, and 6 months
Height of keratinized tissue	up to 6 months	distance from the most apical point of the free gingival margin to the mucogingival junction mid-facially measured at baseline , 1, 3, and 6 months

Secondary Outcome Measures

Name	Time	Method
probing pocket depth	up to 6 months	measured from gingival margin to the bottom of the pocket measured at baseline, 3, and 6 months
healing index	up to 6 months	recorded at 1, 3 and 6 months postoperatively (Score 1: uneventful healing while score 3: poor wound healing
Digital measurements	up to 6 months	all recession areas were photographed The photos were taken by a digital camera at a fixed resolution (mega pixel) taken at baseline, 1,3,and 6 months postoperative
clinical attachment level	up to 6 months	measured from CEJ to the bottom of the pocket measured at baseline, 3, and 6 months

Trial Locations

Locations (2)

Malak Yousef Mohamed Shoukheba; 🇪🇬 Tanta, Egypt

Malak Mohamed Shoukheba; 🇪🇬 Tanta, Egypt