- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05287152
Titanium Tacked Soft Tissue Stabilization : A Novel Technique For Free Gingival Graft Fixation
March 10, 2022 updated by: Mohamed Khairy Mohammed Tammam, Egyptian Biomedical Research Network
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
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
-
-
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Cairo, Egypt
- Faculty Od Dentistry - Cairo University
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
evaluation of the amount of the free gingival graft contraction when being fixed using the titanium tacks( bone tacks)
Time Frame: 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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
- Thoma DS, Naenni N, Figuero E, Hammerle CHF, Schwarz F, Jung RE, Sanz-Sanchez I. Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Mar;29 Suppl 15:32-49. doi: 10.1111/clr.13114.
- Dragan IF, Hotlzman LP, Karimbux NY, Morin RA, Bassir SH. Clinical Outcomes of Comparing Soft Tissue Alternatives to Free Gingival Graft: A Systematic Review and Meta-Analysis . J Evid Based Dent Pract. 2017 Dec;17(4):370-380.e3. doi: 10.1016/j.jebdp.2017.05.008. Epub 2017 May 26.
- Lim HC, An SC, Lee DW. A retrospective comparison of three modalities for vestibuloplasty in the posterior mandible: apically positioned flap only vs. free gingival graft vs. collagen matrix. Clin Oral Investig. 2018 Jun;22(5):2121-2128. doi: 10.1007/s00784-017-2320-y. Epub 2017 Dec 23.
- Greenwell H, Fiorellini J, Giannobile W, Offenbacher S, Salkin L, Townsend C, Sheridan P, Genco R; Research, Science and Therapy Committee. Oral reconstructive and corrective considerations in periodontal therapy. J Periodontol. 2005 Sep;76(9):1588-600. doi: 10.1902/jop.2005.76.9.1588.
- Korkis S, Thompson TN, Vizirakis MA, Lamble M, Zimmerman D, Neely AL, Kinaia BM. Stabilization Techniques for Soft Tissue Grafting Around Dental Implants: Case Report. Clin Adv Periodontics. 2019 Dec;9(4):192-195. doi: 10.1002/cap.10071. Epub 2019 Sep 23.
- Shi Y, Segelnick SL, El Chaar ES. A Modified Technique of Tacking Acellular Dermal Matrix to Increase Keratinized Mucosa Around Dental Implants as an Alternative to a Free Gingival Graft: A Case Report. Clin Adv Periodontics. 2020 Dec;10(4):175-180. doi: 10.1002/cap.10113. Epub 2020 Aug 13.
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)
March 1, 2021
Primary Completion (Actual)
December 6, 2021
Study Completion (Actual)
January 2, 2022
Study Registration Dates
First Submitted
March 10, 2022
First Submitted That Met QC Criteria
March 10, 2022
First Posted (Actual)
March 18, 2022
Study Record Updates
Last Update Posted (Actual)
March 18, 2022
Last Update Submitted That Met QC Criteria
March 10, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- free gingival graft fixation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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