The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants

April 7, 2020 updated by: Oya Turkoglu, Ege University
There are studies investigating the dimensional changes following free gingival graft (FGG) around teeth with inadequate attached gingiva, however no study investigating the effect of smoking on dimensional changes following FGG around dental implants exists. In the present study, we hypothesized that smoking might increase the dimensional change of FGG around dental implants and affect the healing of donor site.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Implants with inadequate attached gingiva on the buccal site, which placed in posterior region at least 1 year ago, and loaded with a fixed prosthetic restoration at least 6 months ago.

Exclusion Criteria:

Implants with peri-implantitis, patients who had previously the soft or hard tissue graft surgery at the site in question, patients who had previously operated from the donor site, patients with systemic disease that may interfere with periodontal surgery, patients taking any medication that can prolong bleeding, patients with immune system disease, infectious diseases such as hepatitis or HIV, individuals under the age of 18, and women with pregnant or breastfeeding.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: smoker
Those consuming at least 10 cigarette a day for ten years were included in smoker group.
Procedure: Free gingival graft
Following recipient site preparation, free gingival graft obtained from palatal mucosa was applied to buccal sites of dental implants having inadequate keratinized attached mucosa.
Active Comparator: non-smoker
Patients who never smoke were included in non-smoker group. Patients who quit smoking were not included in this group.
Procedure: Free gingival graft
Following recipient site preparation, free gingival graft obtained from palatal mucosa was applied to buccal sites of dental implants having inadequate keratinized attached mucosa.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dimensional change of free gingival graft
Time Frame: 0,1, 3, 6 months
the changes in vertical dimension of free gingival graft was measured by functional and visual methods intra-orally by individual stents, and horizontal dimension of free gingival graft was measured on digital photographs using specific software.
0,1, 3, 6 months
change in total free gingival graft area
Time Frame: 0, 7th day, 1,3, 6 months
total free gingival graft area was calculated on digital photographs using specific software.
0, 7th day, 1,3, 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Depth of vestibule sulcus
Time Frame: 0, 7th day, 1,3, 6 months
0, 7th day, 1,3, 6 months
tissue thickness of recipient and donor sites
Time Frame: 0, 7th day, 1,3, 6 months
0, 7th day, 1,3, 6 months
VAS
Time Frame: 0,1,2,3,4,5,6,7. days
0,1,2,3,4,5,6,7. days

Collaborators and Investigators

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

Sponsor

Ege University

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 (Actual)

September 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 7, 2020

First Posted (Actual)

April 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 10, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-DIS-011

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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