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

GINGIVAL RECESSION Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05782751
• Other study ID #: 6
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: March 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• GINGIVAL RECESSION

Intervention

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

Locations

Country	Name	City	State
Egypt	Malak Mohamed Shoukheba	Tanta
Egypt	Malak Yousef Mohamed Shoukheba	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recession width	the distance between the mesial and distal papillae along the CEJ measured at baseline , 1, 3, and 6 months	up to 6 months
Primary	recession depth	The distance between the CEJ and the gingival margin at the midbuccal aspect of the involved tooth measured at baseline , 1, 3, and 6 months	up to 6 months
Primary	Height of keratinized tissue	distance from the most apical point of the free gingival margin to the mucogingival junction mid-facially measured at baseline , 1, 3, and 6 months	up to 6 months
Primary	Gingival thickness (Gingival biotype)	measured at mid-buccal area 2 mm apical to the free gingival margin measured at baseline, and 6 months postoperatively	up to 6 months
Primary	radiographic measurements of facial bone level, thickness and density	from cone beam CT radiography measured at baseline, and 6 months postoperative	up to 6 months
Primary	Percentage of root coverage	according to the following formula: (RD at baseline - RD at 6 months) / RD at baseline)x100 was calculated after 6 months	up to 6 months
Secondary	probing pocket depth	measured from gingival margin to the bottom of the pocket measured at baseline, 3, and 6 months	up to 6 months
Secondary	clinical attachment level	measured from CEJ to the bottom of the pocket measured at baseline, 3, and 6 months	up to 6 months
Secondary	Digital measurements	all 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	up to 6 months
Secondary	healing index	recorded at 1, 3 and 6 months postoperatively (Score 1: uneventful healing while score 3: poor wound healing	up to 6 months