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NCT04340830 Clinical Trial

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

Smoking Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04340830
Other study ID # 2016-DIS-011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date August 2017

Study information
Verified date April 2020
Source Ege University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ege University

Outcome
Type Measure Description Time frame Safety issue
Primary dimensional change of free gingival graft 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
Primary change in total free gingival graft area total free gingival graft area was calculated on digital photographs using specific software. 0, 7th day, 1,3, 6 months
Secondary Depth of vestibule sulcus 0, 7th day, 1,3, 6 months
Secondary tissue thickness of recipient and donor sites 0, 7th day, 1,3, 6 months
Secondary VAS 0,1,2,3,4,5,6,7. days
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