CClinicalTrials.gg
Status unknownNCT04375618Updated May 5, 2020

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

A Phase 1 interventional study of RhEGF and Plain Collagen in Periodontitis, sponsored by SVS Institute of Dental Sciences. Status unknown at 1 site in India. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-05-05.

Sponsored by SVS Institute of Dental Sciences · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2019, registered Apr 2020).
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Periodontitis

Keywords

  • epidermal growth factor
  • gingival recession
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's planned enrollment of 30 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

SVS Institute of Dental Sciences is the lead sponsor of 21 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients who are medically compromised and Subjects who underwent radiotherapy or chemotherapy and who are Smokers are excluded from the study
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    EGF impregnated in collagen membrane

    EGF impregnated in collagen membrane is placed in gingival recession defects

    Drug: RhEGF

  • Active comparator
    plain collagen membrane

    plain collagen membrane is placed in gingival recession defects

    Drug: Plain Collagen

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.

    Also known as: EGF+Collagen

  • DrugPlain Collagen

    A collagen membrane without FGF-2 will be used.

    Also known as: Control group

06

What researchers measure

Primary outcomes

  1. 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

  1. 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.

07

Study locations

1 of 1 sites recruiting
  • R V Chandra
    Hyderabad, Telangana 509002, India
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04375618
Lead sponsor
SVS Institute of Dental Sciences
Responsible party
Dr R Viswa Chandra (Primary Investigator, SVS Institute of Dental Sciences) — Principal investigator
First posted
May 5, 2020
Start date
Oct 1, 2019
Primary completion
Oct 2020 (estimated)
Completion
Nov 2021 (estimated)
Last update
May 5, 2020

Study contacts

R V Chandra, MDS;DNB;PHD
Contact
viswachandra@hotmail.com
9908183071

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion