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

NCT ID: NCT05782751

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-08-30

Brief Summary

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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

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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

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GINGIVAL RECESSION

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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(groupI)

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

Group Type EXPERIMENTAL

GROUPI

Intervention Type PROCEDURE

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

(groupII)

10 recession sites GEM 21s with collagen membrane

Group Type ACTIVE_COMPARATOR

GROUP II

Intervention Type PROCEDURE

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

Interventions

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GROUPI

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

Intervention Type PROCEDURE

GROUP II

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

Intervention Type PROCEDURE

Other Intervention Names

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free connective tissue graft growth factors enhanced matrix 21s (GEM21s) coronally advanced flap collagen membrane coronally advanced flap

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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malak mohamed shoukheba

professor of oral medicine, oral periodontology, oral diagnosis and diagnosis

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Malak Mohamed Shoukheba

Tanta, , Egypt

Site Status

Malak Yousef Mohamed Shoukheba

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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6

Identifier Type: -

Identifier Source: org_study_id

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