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Clinical Trials/NCT06065254
NCT06065254CompletedNot Applicable

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

Damascus University1 site in 1 country18 target enrollmentStarted: May 10, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
1
Primary Endpoint
The thickness of the peri-implant soft tissues

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 83 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Free gingival graft

Experimental

Free gingival graft will be applied and and followed for 3 months

Intervention: Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness (Other)

Connective tissue graft

Experimental

Connective tissue graft will be applied and and followed for 3 months

Intervention: Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness (Other)

No grafts will be applied.

Other

No grafts of any types will be applied.

Intervention: No types of grafts will be made to improve the quality of the peri-implant mucosa (Other)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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