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

Sponsor
Damascus University (Other)
Overall Status
Completed
CT.gov ID
NCT06065254
Collaborator
(none)
18
1
3
15.5
1.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness
  • Other: Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness
  • Other: No types of grafts will be made to improve the quality of the peri-implant mucosa
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Gingival Grafts During the Implantation Process in the Increasing of Peri-implant Keratinized Tissue Width and Soft Tissues Thickness
Actual Study Start Date :
May 10, 2022
Actual Primary Completion Date :
Feb 14, 2023
Actual Study Completion Date :
Aug 25, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The width of the keratinized gingiva [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.

  2. The thickness of the peri-implant soft tissues [after 1 month and 3 months]

    The thickness of the peri-implant soft tissues will be measured clinically by the direct transgingival propping method.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 83 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Damascus University Damascus Syrian Arab Republic

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Damascus University
ClinicalTrials.gov Identifier:
NCT06065254
Other Study ID Numbers:
  • UDDS-Perio-01-2023
First Posted:
Oct 3, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Damascus University

Study Results

No Results Posted as of Oct 3, 2023