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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05782751
Enrollment
10
Registered
2023-03-24
Start date
2019-01-01
Completion date
2022-08-30
Last updated
2023-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GINGIVAL RECESSION

Keywords

Gingival recession, free subepithelial connective tissue graft, collagen membrane, growth factor enhanced matrix 21 s

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 .

Interventions

PROCEDUREGROUPI

10 sites treated with Free connective tissue graft (FCTG) + growth factors enhanced matrix 21 s GEM 21S + coronally advanced flap (CAF)

PROCEDUREGROUP II

10 sites treated withCollagen membrane + GEM 21S + coronally advanced flap (CAF)

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of root coverageup to 6 monthsaccording to the following formula: (RD at baseline - RD at 6 months) / RD at baseline)x100 was calculated after 6 months
recession depthup to 6 monthsThe 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 tissueup to 6 monthsdistance from the most apical point of the free gingival margin to the mucogingival junction mid-facially measured at baseline , 1, 3, and 6 months
Gingival thickness (Gingival biotype)up to 6 monthsmeasured at mid-buccal area 2 mm apical to the free gingival margin measured at baseline, and 6 months postoperatively
radiographic measurements of facial bone level, thickness and densityup to 6 monthsfrom cone beam CT radiography measured at baseline, and 6 months postoperative
Recession widthup to 6 monthsthe distance between the mesial and distal papillae along the CEJ measured at baseline , 1, 3, and 6 months

Secondary

MeasureTime frameDescription
clinical attachment levelup to 6 monthsmeasured from CEJ to the bottom of the pocket measured at baseline, 3, and 6 months
Digital measurementsup to 6 monthsall 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
healing indexup to 6 monthsrecorded at 1, 3 and 6 months postoperatively (Score 1: uneventful healing while score 3: poor wound healing
probing pocket depthup to 6 monthsmeasured from gingival margin to the bottom of the pocket measured at baseline, 3, and 6 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026