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

S

SVS Institute of Dental Sciences

Status and phase

Unknown
Phase 1

Conditions

Periodontitis

Treatments

Drug: Plain Collagen
Drug: RhEGF

Study type

Interventional

Funder types

Other

Identifiers

NCT04375618
SVSIDS/perio/5/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

EGF impregnated in collagen membrane
Experimental group
Description:
EGF impregnated in collagen membrane is placed in gingival recession defects
Treatment:
Drug: RhEGF
plain collagen membrane
Active Comparator group
Description:
plain collagen membrane is placed in gingival recession defects
Treatment:
Drug: Plain Collagen

Trial contacts and locations

1

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Central trial contact

R V Chandra, MDS;DNB;PHD

Data sourced from clinicaltrials.gov

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