NCT05782751

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

Growth Factor Enhanced Matrix Combined Either With Free Connective Tissue Graft or With Collagen Membrane in the Treatment of Miller Class II Gingival Recession

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 25 Years – 50 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• GINGIVAL RECESSION

Interventions

Type	Name	Description
PROCEDURE	GROUPI	10 sites treated with Free connective tissue graft (FCTG) + growth factors enhanced matrix 21 s GEM 21S + coronally advanced flap (CAF)
PROCEDURE	GROUP II	10 sites treated withCollagen membrane + GEM 21S + coronally advanced flap (CAF)

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-08-30
• Completion: 2022-08-30
• First posted: 2023-03-24
• Last updated: 2023-03-24

Locations

2 sites across 1 country: Egypt

Regulatory

• FDA-regulated drug study
• FDA-regulated device study