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Clinical Trials/NCT06264869
NCT06264869UnknownNot Applicable

A Novel Approach of Interdental Guided Creeping Technique (IGCT) for Augmentation of Deficient Interdental Papillae: Randomized Clinical Trial

October 6 University0 sites20 target enrollmentStarted: February 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Primary Endpoint
Black triangle height

Study Overview

Brief Summary

The aim of this randomized clinical trial is to treat interdental papillary deficiency with minimally invasive interdental guided creeping technique (IGCT) comparing collagen membrane versus connective tissue graft.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Healthy patients having interdental papilla deficiency.
  • •Good Oral Hygiene.
  • •Age range: 18 - 50 years.

Exclusion Criteria

  • •Pregnancy or lactation.
  • •Alcoholic patients and drug abusers.
  • •Handicapped and prisoners.

Arms & Interventions

IGCT + CTG

Experimental

Interdental guided creeping technique (IGCT) + Connective tissue graft (CTG)

Intervention: Interdental guided creeping technique (IGCT) and connective tissue graft (CTG) (Procedure)

IGCT + CM

Experimental

Interdental guided creeping technique (IGCT) + Collagen membrane (CM)

Intervention: Interdental guided creeping technique (IGCT) and collagen membrane (CM) (Procedure)

Outcomes

Primary Outcomes

Black triangle height

Time Frame: Baseline, 1, 3 and 6 months.

In mm

Secondary Outcomes

  • Papillary height, attached gingiva width(Baseline, 1, 3 and 6 months.)
  • Papillary gain, black triangle reduction(Baseline, 1, 3 and 6 months.)
  • Gingival index(Baseline, 1, 3 and 6 months.)
  • Patient Reported Outcome(1, 3 and 6 months.)
  • Percentage of interdental papillary fill(Baseline, 1, 3 and 6 months.)
  • Duration of surgery(At time of surgery)
  • Pocket depth, clinical attachment level, keratinized tissue thickness(Baseline, 3 and 6 months.)
  • Plaque index(Baseline, 1, 3 and 6 months.)
  • Patient Reported Outcome(At the day of surgery and the 1st 10 days postoperative.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Y Gamal

Professor of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Ain Shams University. Professor of Periodontology, College of Oral and Dental Surgery, Misr University for Science and Technology.

Ain Shams University

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