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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04375618

Enrollment

Registered

2020-05-05

Start date

2019-10-01

Completion date

2021-11-30

Last updated

2020-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

epidermal growth factor, gingival recession

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.

Interventions

DRUGRhEGF

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.

DRUGPlain Collagen

A collagen membrane without FGF-2 will be used.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Recession depth (RD)	Base line to 6months.	Recession depth (RD) - measured from cementoenamel junction to most apical extension of gingival margin.

Secondary

Measure	Time frame	Description
Width of keratinized gingiva (KGW)	Base line to 6months.	Width of keratinized gingiva (KGW) - distance between gingival margin and mucogingival junction will be evaluated.

Countries

India

Contacts

Primary ContactR V Chandra, MDS;DNB;PHD

viswachandra@hotmail.com9908183071

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026