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

Primary Purpose

Periodontitis

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
RhEGF
Plain Collagen
Sponsored by
SVS Institute of Dental Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring epidermal growth factor, gingival recession

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • R V ChandraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EGF impregnated in collagen membrane

plain collagen membrane

Arm Description

EGF impregnated in collagen membrane is placed in gingival recession defects

plain collagen membrane is placed in gingival recession defects

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 29, 2020
Last Updated
May 2, 2020
Sponsor
SVS Institute of Dental Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04375618
Brief Title
RhEGF Incorporated in An Absorbable Collagen Membrane for The Management Of Gingival Recession Defects
Official Title
Efficacy of Recombinant Human Epidermal Growth Factor (RhEGF) Incorporated in An Absorbable Collagen Membrane for The Management of Gingival Recession Defects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SVS Institute of Dental Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
epidermal growth factor, gingival recession

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EGF impregnated in collagen membrane
Arm Type
Experimental
Arm Description
EGF impregnated in collagen membrane is placed in gingival recession defects
Arm Title
plain collagen membrane
Arm Type
Active Comparator
Arm Description
plain collagen membrane is placed in gingival recession defects
Intervention Type
Drug
Intervention Name(s)
RhEGF
Other Intervention Name(s)
EGF+Collagen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Plain Collagen
Other Intervention Name(s)
Control group
Intervention Description
A collagen membrane without FGF-2 will be used.
Primary Outcome Measure Information:
Title
Recession depth (RD)
Description
Recession depth (RD) - measured from cementoenamel junction to most apical extension of gingival margin.
Time Frame
Base line to 6months.
Secondary Outcome Measure Information:
Title
Width of keratinized gingiva (KGW)
Description
Width of keratinized gingiva (KGW) - distance between gingival margin and mucogingival junction will be evaluated.
Time Frame
Base line to 6months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
R V Chandra, MDS;DNB;PHD
Phone
9908183071
Email
viswachandra@hotmail.com
Facility Information:
Facility Name
R V Chandra
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
509002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R V Chandra, MDS;DNB;PhD
Phone
9908183071
Email
viswachandra@hotmail.com

12. IPD Sharing Statement

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

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