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NCT04099680 · ClinicalTrials.gov registry record · NA

Free Gingival Grafts (FGGs) in Mandibular Posterior Sites

A NA study of Lack of Keratinized Tissue, sponsored by Ohio State University.

Active
Registry status
NA
Development phase
13
Enrollment target
1
Study location

NCT04099680: Active NA study of Lack of Keratinized Tissue, sponsored by Ohio State University.

NCT04099680 is a NA study of Lack of Keratinized Tissue that is active but no longer recruiting, run by Ohio State University. The registered enrollment target is 13 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04099680, a NA study of Lack of Keratinized Tissue, is active but no longer recruiting, sponsored by Ohio State University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
13 participants
Enrollment target
1
Study location

Study Summary

In this proposed study a novel technique that utilizes bone screws as an anchorage device will be used to facilitate suturing and ensure graft tissue immobilization on full thickness recipient bed preparation sites. Currently, no information is available on free gingival graft treatment outcomes comparing full thickness recipient bed preparation, i.e., no periosteum remaining under the free gingival graft, with the aid of bone screws versus a conventional partial thickness recipient bed preparation with periosteum remaining under the graft. The purpose of the present study is to investigate the effect of these two different recipient bed preparations on soft tissue dimension change, graft and surgical wound healing, patient comfort, surgical complication frequency and operator satisfaction after free gingival graft to increase the width of keratinized gingival tissue in mandibular posterior sites. The purpose of the present study is to investigate the effect of these two different recipient bed preparations on soft tissue dimension change, graft and surgical wound healing, patient comfort, surgical complication frequency and operator satisfaction after free gingival graft procedure to increase the width of keratinized gingival tissue in mandibular posterior sites. The specific aims of this research study contain two aspects: 1. To compare the wound healing of a free gingival graft using either a partial thickness flap or full-thickness flap preparation with bone screws at the recipient site around mandibular posterior areas. 2. To assess patient comfort and surgeon satisfaction with a free gingival graft procedure using these two different recipient bed preparations.

Conditions Studied

Interventions

  • PROCEDURE Partial thickness recipient bed
  • PROCEDURE Full thickness recipient bed
  • DEVICE Bone screw (FDA approved bone screw)
  • PROCEDURE Periosteal sutures
  • PROCEDURE Sling sutures

Study Locations (1)

Ohio

  • The Ohio State University College of Dentistry - Columbus

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2020-12-31
Est. Completion 2025-04-15
Phase NA
Ohio State University

552 total trials

What the registry record for NCT04099680 still lists

NCT04099680 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Lack of Keratinized Tissue appearing as the primary indexed condition, and to 5 interventions - of which Partial thickness recipient bed is the first listed.

NCT04099680 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT04099680 about?

NCT04099680 is a clinical study titled "Free Gingival Grafts (FGGs) in Mandibular Posterior Sites". In this proposed study a novel technique that utilizes bone screws as an anchorage device will be used to facilitate suturing and ensure graft tissue immobilization on full thickness recipient bed preparation sites. Currently, no information is available on free gingival graft treatment outcomes com...

What is the current status of trial NCT04099680?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 13 participants. The study started on 2020-12-31. Estimated completion is 2025-04-15.

What conditions does trial NCT04099680 study?

This clinical trial studies the following conditions: Lack of Keratinized Tissue.

What interventions are being tested in trial NCT04099680?

The interventions under investigation include: Partial thickness recipient bed (PROCEDURE), Full thickness recipient bed (PROCEDURE), Bone screw (FDA approved bone screw) (DEVICE), Periosteal sutures (PROCEDURE), Sling sutures (PROCEDURE).

Who is sponsoring clinical trial NCT04099680?

This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04099680 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04099680's enrollment target sits among peer trials

13 1911th of 2000 higher than 88 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04099680, the US trial registry maintained by the National Library of Medicine. NCT04099680 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.