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

Tanta University

Status and phase: Completed; Phase 4

Conditions: GINGIVAL RECESSION

Treatments: Procedure: GROUP II; Procedure: GROUPI

Study type: Interventional

Funder types: Other

Identifiers

NCT05782751

6

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 10 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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10 participants in 2 patient groups

(groupI)

Experimental group

Description:

10 recession sites treated by (GEM 21s) ® with free connective tissue graft

Treatment:

Procedure: GROUPI

(groupII)

Active Comparator group

Description:

10 recession sites GEM 21s with collagen membrane

Treatment:

Procedure: GROUP II