RhEGF Incorporated in An Absorbable Collagen Membrane for The Management Of Gingival Recession Defects

Phase 1

• Conditions: Periodontitis
• Interventions: Drug: Plain Collagen; Drug: RhEGF

• Registration Number: NCT04375618
• Lead Sponsor: SVS Institute of Dental Sciences

Brief Summary

A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.

Detailed Description

IN TEST SITE :

Local anesthesia will be administered and Vertical incisions will be given at interdental papillae away from recession defect site and a pouch will be created. A sulcular incision will be made through each recession area and the tissues will be gradually undermined including the base of the interdental papilla. At the recession sites rhEGF incorporated absorbable collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.

IN CONTROL SITE:

Same procedure will be done as the test site but plain collagen membrane will be gradually manipulated into the pouch through the tunnel till it covers the recession sites and will be stabilized with sutures.

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2020-04-29
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-02
• Last Update Submitted: 2020-05-02
• Study First Posted: 2020-05-05
• Last Update Posted: 2020-05-05
• Primary Completion: 2020-10
• Study Completion: 2021-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Systemically healthy male and female patients of age 20-55 yrs with Millers class I or class II gingival recession are included in the study.

Exclusion Criteria

• Patients who are medically compromised and Subjects who underwent radiotherapy or chemotherapy and who are Smokers are excluded from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
plain collagen membrane	Plain Collagen	plain collagen membrane is placed in gingival recession defects
EGF impregnated in collagen membrane	RhEGF	EGF impregnated in collagen membrane is placed in gingival recession defects

Primary Outcome Measures

Name	Time	Method
Recession depth (RD)	Base line to 6months.	Recession depth (RD) - measured from cementoenamel junction to most apical extension of gingival margin.

Secondary Outcome Measures

Name	Time	Method
Width of keratinized gingiva (KGW)	Base line to 6months.	Width of keratinized gingiva (KGW) - distance between gingival margin and mucogingival junction will be evaluated.

Trial Locations

Locations (1)

R V Chandra; 🇮🇳 Hyderabad, Telangana, India