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

Periodontitis Clinical Trial

Official title:

Efficacy of Recombinant Human Epidermal Growth Factor (RhEGF) Incorporated in An Absorbable Collagen Membrane for The Management of Gingival Recession Defects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04375618
• Other study ID #: SVSIDS/perio/5/2019
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2019
• Est. completion date: November 2021

Study information

• Verified date: May 2020
• Source: SVS Institute of Dental Sciences
• Contact: R V Chandra, MDS;DNB;PHD
• Phone: 9908183071
• Email: viswachandra[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Periodontitis

Intervention

Drug:
• RhEGF
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 Collagen
A collagen membrane without FGF-2 will be used.

Locations

Country	Name	City	State
India	R V Chandra	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
SVS Institute of Dental Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recession depth (RD)	Recession depth (RD) - measured from cementoenamel junction to most apical extension of gingival margin.	Base line to 6months.
Secondary	Width of keratinized gingiva (KGW)	Width of keratinized gingiva (KGW) - distance between gingival margin and mucogingival junction will be evaluated.	Base line to 6months.