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

NCT04340830 | Completed

• 1 other identifier: 2016-DIS-011
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Smoking; Free Gingival Graft; Dental Implant

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Depth of vestibule sulcus

  0, 7th day, 1,3, 6 months

• tissue thickness of recipient and donor sites

  0, 7th day, 1,3, 6 months

• VAS

  0,1,2,3,4,5,6,7. days

Study Arms (2)

smoker

EXPERIMENTAL

Those consuming at least 10 cigarette a day for ten years were included in smoker group.

Procedure: Free gingival graft

non-smoker

ACTIVE COMPARATOR

Patients who never smoke were included in non-smoker group. Patients who quit smoking were not included in this group.

Procedure: Free gingival graft

Interventions

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.

non-smoker; smoker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: September 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 10, 2020

Record last verified: 2020-04