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

Not Applicable

Completed

• Conditions: Dental Implants; Transplants
• Interventions: Other: Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness; Other: Efficacy of free gingival 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

• Registration Number: NCT06065254
• Lead Sponsor: Damascus University

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.

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 Timeline

• Study Start: 2022-05-10
• Primary Completion: 2023-02-14
• Study Completion: 2023-08-25
• Status Verified: 2023-09
• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-09-27
• Last Update Submitted: 2023-09-27
• Study First Posted: 2023-10-03
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Connective tissue graft	Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness	Connective tissue graft will be applied and and followed for 3 months
Free gingival graft	Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness	Free gingival graft will be applied and and followed for 3 months
No grafts will be applied.	No types of grafts will be made to improve the quality of the peri-implant mucosa	No grafts of any types will be applied.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Damascus University; 🇸🇾 Damascus, Syrian Arab Republic