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

NCT04375618 | Unknown Phase 1

• 1 other identifier: SVSIDS/perio/5/2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

epidermal growth factor; gingival recession

Outcome Measures

Primary Outcomes (1)

• Recession depth (RD)

  Recession depth (RD) - measured from cementoenamel junction to most apical extension of gingival margin.

  Base line to 6months.

Secondary Outcomes (1)

• Width of keratinized gingiva (KGW)

  Base line to 6months.

Study Arms (2)

EGF impregnated in collagen membrane

EXPERIMENTAL

EGF impregnated in collagen membrane is placed in gingival recession defects

Drug: RhEGF

plain collagen membrane

ACTIVE COMPARATOR

plain collagen membrane is placed in gingival recession defects

Drug: Plain Collagen

Interventions

RhEGF DRUG

The EGF impregnated membrane will be placed upon the recession site and will be stabilized by suturing it to the lingual papillae using 4-0 absorbable sutures. The flap will be coronally advanced as far as possible to cover the membrane and will be sutured to the buccal interdental papillae with 4-0 absorbable sutures (Trulenetm, Healthium Medtech Pvt Ltd, Bangalore, India). Standard recall and maintenance regimen will be followed and subjects will be encouraged to report to the department on a monthly basis.

Also known as: EGF+Collagen

EGF impregnated in collagen membrane

Plain Collagen DRUG

A collagen membrane without FGF-2 will be used.

Also known as: Control group

plain collagen membrane

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead

Study Sites (1)

R V Chandra

Hyderabad, Telangana, 509002, India

RECRUITING

MeSH Terms

Conditions

Periodontitis; Gingival Recession

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

R V Chandra, MDS;DNB;PHD

CONTACT

9908183071; viswachandra@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 5, 2020
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: November 1, 2021
• Last Updated: May 5, 2020

Record last verified: 2020-05

Locations

IN (1)