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

SVS Institute of Dental Sciences30 enrolled

Overview

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 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Periodontitis

Interventions

RhEGFDRUG

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.

Plain CollagenDRUG

A collagen membrane without FGF-2 will be used.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

R V Chandra

Hyderabad, Telangana, India

RECRUITING

Outcomes

Primary Outcomes

Recession depth (RD)

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

Time frame: Base line to 6months.

Secondary Outcomes

Width of keratinized gingiva (KGW)

Width of keratinized gingiva (KGW) - distance between gingival margin and mucogingival junction will be evaluated.

Time frame: Base line to 6months.

Central Contacts

R V Chandra, MDS;DNB;PHD

CONTACT

9908183071 viswachandra@hotmail.com

Data from ClinicalTrials.gov

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