Clinical trial NCT05782751: Growth Factor Enhanced Matrix With Subepithelial Connective Tissue Graft or Collagen Membrane in Treatment of Gingival Recession
Official title: Growth Factor Enhanced Matrix Combined Either With Free Connective Tissue Graft or With Collagen Membrane in the Treatment of Miller Class II Gingival Recession
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: GINGIVAL RECESSION
Keywords: Gingival recession
free subepithelial connective tissue graft
collagen membrane
growth factor enhanced matrix 21 s
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Recession width
timeFrame: up to 6 months
measure: recession depth
timeFrame: up to 6 months
measure: Height of keratinized tissue
timeFrame: up to 6 months
measure: Gingival thickness (Gingival biotype)
timeFrame: up to 6 months
measure: radiographic measurements of facial bone level, thickness and density
timeFrame: up to 6 months
measure: Percentage of root coverage
timeFrame: up to 6 months
Secondary outcomes:
measure: probing pocket depth
timeFrame: up to 6 months
measure: clinical attachment level
timeFrame: up to 6 months
measure: Digital measurements
timeFrame: up to 6 months
measure: healing index
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Malak Mohamed Shoukheba
city: Tanta
country: Egypt
facility: Malak Yousef Mohamed Shoukheba
Study officials:
References: