The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life

March 23, 2021 updated by: Serap Karakış Akcan, University of Beykent

The Evaluation of Free Gingival Graft Operations Around Implant or Teeth on Quality of Life: Parallel-controlled Prospective Clinical Trial

The purpose of this study is to evaluate the quality of life of patients who underwent FGG surgery around the natural tooth and as a second surgery after the implant operation, in comparison with general oral health assesment index(GOHAI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirty-two participants were included who were referred to the periodontology clinic suffering insufficient keratinized gingiva / mucosa deficiency around the implant and / or tooth/teeth. GOHAI-total and GOHAI psychological impact, functional limitation, pain and discomfort, behavioral impact subcategories were recorded at before and postoperative first week and 30th day. Also, satisfaction questionnaires, number of painkillers and visual analog scale values were recorded.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34500
        • Beykent University Faculty of Dentistry

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-smoking
  • Teeth and implants with keratinized gingiva width <1 mm
  • A healthy periodontal and peri-implant condition
  • Patients who didn't have ever experience periodontal surgery had first oral surgery experience with dental FGG operation for the first time
  • Patients who underwent implant surgery for the first oral surgery experience
  • Maximum two teeth/implants on recipient area

Exclusion Criteria:

  • Patients receiving any medication to disrupt wound healing
  • Lactation or pregnancy
  • Caries or defects on the tooth root surface
  • Periapical lesion in the recipient area active periodontal disease
  • Patients who have previously had periodontal or oral surgery experiences

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Free gingival graft around dental implant patients
Test Group (TG) consists of patients have free gingival graft around dental implant patients
Procedure: Free Gingival Graft
In the recipient area, a half-thickness flap with two vertical incision widths was removed with a horizontal incision with 15C blades from the mucogingival junction. The recipient site was determined such that one or two teeth or one tooth extends into the mesial and distal regions of the tooth. Muscle attachments were dissected and FGG was placed on recipient bed and non-resorbable monofilament sutures were used for fixing the four corners of the graft.
Active Comparator: Free gingival graft around the teeth
Control Group (CG) consists of patients have free gingival graft around the teeth.
Procedure: Free Gingival Graft
In the recipient area, a half-thickness flap with two vertical incision widths was removed with a horizontal incision with 15C blades from the mucogingival junction. The recipient site was determined such that one or two teeth or one tooth extends into the mesial and distal regions of the tooth. Muscle attachments were dissected and FGG was placed on recipient bed and non-resorbable monofilament sutures were used for fixing the four corners of the graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Oral Health Assesment Index (GOHAI) scores- intragroup comparisons change between from baseline to other follow-up times and intergroup comparisons all follow-up times
Time Frame: Baseline, postoperative 1., 2., 3., 4., 5., 6. and 7. days and first month.
The questions that contains 12 items and that give subcategorized about functional limitations, pain and discomfort, psychological impacts, and behavioral impact.
Baseline, postoperative 1., 2., 3., 4., 5., 6. and 7. days and first month.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: baseline
18-65 years
baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gender
Time Frame: baseline
male, female
baseline
Keratinized gingival width (KGW)
Time Frame: baseline, first month
the distance between the gingival margin and mucogingival junction from tooth/implant in operation area
baseline, first month
Graft volume (GV)
Time Frame: during surgery
graft vertical height X graft mesiodistal length X graft thickness
during surgery
Surgery localization
Time Frame: baseline
maxilla, mandible, anterior, posterior
baseline
Operation time
Time Frame: during surgery
operation time between of first incision and last suture
during surgery
Satisfaction questionnaires
Time Frame: first month
A questionnaire designed by authors with 12 questions was used to assess patient satisfaction. Answers were either categorized as "positive" or "negative".
first month
Visual Analog Scale (VAS)
Time Frame: postoperative 1., 2., 3., 4., 5., 6. and 7. days
a 100-mm horizontal scale and classify the level of postoperative pain experience from 0 (no pain) to 100 (the worst pain ever experienced)
postoperative 1., 2., 3., 4., 5., 6. and 7. days
Painkiller consumption
Time Frame: postoperative 1., 2., 3., 4., 5., 6. and 7. days
the total number of painkillers for each follow-up day
postoperative 1., 2., 3., 4., 5., 6. and 7. days

Collaborators and Investigators

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

Sponsor

University of Beykent

Collaborators

Kutahya Health Sciences University
Istanbul Aydın University

Investigators

  • Principal Investigator: berceste güler, phd, Kutahya Health Sciences University
  • Study Director: serap karakış akcan, phd, Beykent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2017

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

March 4, 2019

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B.30.2.AYD.0.00.00-480.2/184

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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