Interdental Guided Creeping Technique

February 15, 2024 updated by: Ahmed Y Gamal, October 6 University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IGCT + CTG
Interdental guided creeping technique (IGCT) + Connective tissue graft (CTG)
Procedure: Interdental guided creeping technique (IGCT) and connective tissue graft (CTG)
Interdental guided creeping technique (IGCT) and connective tissue graft (CTG)
Experimental: IGCT + CM
Interdental guided creeping technique (IGCT) + Collagen membrane (CM)
Procedure: Interdental guided creeping technique (IGCT) and collagen membrane (CM)
Interdental guided creeping technique (IGCT) and collagen membrane (CM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Black triangle height
Time Frame: Baseline, 1, 3 and 6 months.
In mm
Baseline, 1, 3 and 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of interdental papillary fill
Time Frame: Baseline, 1, 3 and 6 months.
In %
Baseline, 1, 3 and 6 months.
Papillary gain, black triangle reduction
Time Frame: Baseline, 1, 3 and 6 months.
In mm, %
Baseline, 1, 3 and 6 months.
Papillary height, attached gingiva width
Time Frame: Baseline, 1, 3 and 6 months.
In mm
Baseline, 1, 3 and 6 months.
Pocket depth, clinical attachment level, keratinized tissue thickness
Time Frame: Baseline, 3 and 6 months.
In mm
Baseline, 3 and 6 months.
Plaque index
Time Frame: Baseline, 1, 3 and 6 months.
Scores
Baseline, 1, 3 and 6 months.
Gingival index
Time Frame: Baseline, 1, 3 and 6 months.
Scores
Baseline, 1, 3 and 6 months.
Duration of surgery
Time Frame: At time of surgery
In minutes
At time of surgery
Patient Reported Outcome
Time Frame: At the day of surgery and the 1st 10 days postoperative.
VAS score for pain
At the day of surgery and the 1st 10 days postoperative.
Patient Reported Outcome
Time Frame: 1, 3 and 6 months.
Patient satisfaction (score)
1, 3 and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October 6 University

Investigators

  • Principal Investigator: Ghada G A.GamalElDin, Dr., PhD Student of Periodontology, Faculty of Dentistry, Cairo University
  • Principal Investigator: Mohamed S. Morgan, Dr., Master Student of Periodontology, Faculty of Dentistry, Ain Shams University
  • Study Director: Ahmed Y Gamal, Prof., 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 141123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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