Titanium Tacked Soft Tissue Stabilization : A Novel Technique For Free Gingival Graft Fixation

• Sponsor: Egyptian Biomedical Research Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT05287152
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Actual Duration (Months): 10.1
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

A case series study on ten patients with lack of keratinization in the non-esthetic area .the purpose of the study is the evaluation of using the titanium tacks in free gingival graft fixation as an alternative to the conventional suturing techniques or the tissue adhesives.

Condition or Disease	Intervention/Treatment	Phase
Lack of Keratinized Gingiva	Device: titanium tacks or pins	N/A

Detailed Description

A case series study conducted on 10 patients with lack of keratinization in the non- esthetic areas for clinical evaluation of the effeciancy of the titanium tacks in free gingival graft fixation in terms of the amount of the graft shrinkage through out a six months follow up period . the records will be taken through imagej software for comparing the graft surface area at 1 , 3 and six months .

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Using the titanium tacks in free gingival graft fixation instead of conventional suturing.Using the titanium tacks in free gingival graft fixation instead of conventional suturing.
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Titanium Tacked Soft Tissue Stabilization : A Novel Technique For Free Gingival Graft Fixation
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: Dec 6, 2021
• Actual Study Completion Date: Jan 2, 2022

Outcome Measures

Primary Outcome Measures

1. evaluation of the amount of the free gingival graft contraction when being fixed using the titanium tacks( bone tacks) [6 months]

   evaluating the amount of graft contraction by a software standardized surface area calibration of digital photographs taken at one, three, and six months postoperatively

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patient with lack of keratinization in the non-esthetic areas

Exclusion Criteria:

• patients on chemotherapy

• patients on radiotherapy

• smokers

• patients with bad oral hygiene

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty Od Dentistry - Cairo University	Cairo		Egypt

Sponsors and Collaborators

• Egyptian Biomedical Research Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Khairy Mohammed Tammam, A dentist in oral implantology department ( master degree), Egyptian Biomedical Research Network
• ClinicalTrials.gov Identifier: NCT05287152
• Other Study ID Numbers: free gingival graft fixation
• First Posted: Mar 18, 2022
• Last Update Posted: Mar 18, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 18, 2022