Efficacy of Gingival Grafts During the Implantation Process on the Peri-implant Mucosa

September 27, 2023 updated by: Damascus University

Efficacy of Gingival Grafts During the Implantation Process in the Increasing of Peri-implant Keratinized Tissue Width and Soft Tissues Thickness

This study aims to compare the changes in the peri-implant mucosa during the application of two soft tissue grafting methods, which are free gingival graft (FGG) and connective tissue graft (CTG) taken from the palatine in terms of the width of the keratinized mucosa and the thickness of the peri-implant soft tissues.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The presence of adequate width of the keratinized gingiva may be necessary in some special cases such as the presence of fixed prostheses on the teeth with sublingual margins or peri implants. There is an association between insufficiency of the keratinized tissues peri implants with greater plaque accumulation, signs of inflammation, soft tissue recession, and loss of attachment. The sample will consist of 33 dental implant sites and divide randomly into three groups: Group I (Experiential, n=11): FGG; Group II: (Experiential, n=11): CTG; and Group III: (Control, n=11): No procedure will be done to improve the quality of the peri-implant tissues. The width of the keratinized gingiva will be measured preoperative with a UNC-15 and the thickness of the peri-implant soft tissues will be measured clinically by direct transgingival propping method. These measurements will be repeated after 1 and 3 months.

Study Type

Interventional

Enrollment (Actual)

18

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. patients who have lost posterior teeth (premolars or molars).
  2. A decrease in the amount of keratinized gingiva (less than 2 mm from the alveolar process to the mucogingival junction).
  3. good oral health (plaque index ≤1).

Exclusion Criteria:

  1. heavy smokers (more than 10 cigarettes per day)
  2. uncontrolled diabetes or other systemic diseases.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Free gingival graft
Free gingival graft will be applied and and followed for 3 months
Other: Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness
Two vertical incisions will be made in the previously elevated flap against the placed implant , where these two incisions will be 10 mm apart from each other, and the free graft to will be placed in this distance (10 x 10 mm). The graft will be obtained from the donor site (the hard palate), and will be thinned to obtain a regular graft with the required thickness. After that, the graft will be moved to its correct place accurately, while avoiding leaving a distance between the graft and the tissue underneath, and the graft will be sutured well to ensure its stability and correct placement.
Experimental: Connective tissue graft
Connective tissue graft will be applied and and followed for 3 months
Other: Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness
Vertical incisions will not be made in the previously elevated flap against the placed implant, where there is no need to suture the flap apically of the grafting place because the graft will be covered with it after fixing it in place. The area will be washed with the serum to remove the clot before fixing the graft.The graft will be obtained from the donor site according to the previously mentioned method. Then the epithelium will be removed to leave the connective tissue underneath, and then the graft will be moved to its place (buccally dental implant site) and the flap will be sutured over it.
Other: No grafts will be applied.
No grafts of any types will be applied.
Other: No types of grafts will be made to improve the quality of the peri-implant mucosa
The simple suturing of the two surgical incisions will be done after the completion of the dental implant process, with no procedure will be made to improve the quality of the peri-implant mucosa.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The width of the keratinized gingiva
Time Frame: after 1 month and 3 months
The width of the keratinized gingiva will be measured using a UNC-15 probe from the middle of the alveolar process at the site studied to the mucogingival junction, which was determined by the rollover technique.
after 1 month and 3 months
The thickness of the peri-implant soft tissues
Time Frame: after 1 month and 3 months
The thickness of the peri-implant soft tissues will be measured clinically by the direct transgingival propping method.
after 1 month and 3 months

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Principal Investigator: Ahmad Alshouaa, MSc, MSc student in Periodontology Departement, University of Damascus
  • Study Chair: Mohammed Alsabbagh, Professor of Periodontology, Department of Periodontology, University of Damascus

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 10, 2022

Primary Completion (Actual)

February 14, 2023

Study Completion (Actual)

August 25, 2023

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

September 27, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UDDS-Perio-01-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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