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Completed

NCT Number: NCT04340830

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

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.

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Key information

Conditions

Smoking Behavior Dental Implant Free Gingival Graft

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Free gingival graft

Procedure

Following recipient site preparation, free gingival graft obtained from palatal mucosa was applied to buccal sites of dental implants having inadequate keratinized attached mucosa.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Depth of vestibule sulcus

    Time frame: 0, 7th day, 1,3, 6 months

  2. tissue thickness of recipient and donor sites

    Time frame: 0, 7th day, 1,3, 6 months

  3. VAS

    Time frame: 0,1,2,3,4,5,6,7. days

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 10, 2020
Registry last updated
Apr 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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