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

Lack of Keratinized Gingiva Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05287152
• Other study ID #: free gingival graft fixation
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 2, 2022

Study information

• Verified date: March 2022
• Source: Egyptian Biomedical Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2, 2022
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lack of Keratinized Gingiva

Intervention

Device:
• titanium tacks or pins
using tacks or pins made of titanium 2.5 mm diameter and 4mm length for free gingival graft fixation.

Locations

Country	Name	City	State
Egypt	Faculty Od Dentistry - Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Egyptian Biomedical Research Network

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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 — View Citation

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. R — View Citation

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. — View Citation

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/s007 — View Citation

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: — View Citation

Thoma DS, Naenni N, Figuero E, Hämmerle CHF, Schwarz F, Jung RE, Sanz-Sánchez 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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of the amount of the free gingival graft contraction when being fixed using the titanium tacks( bone tacks)	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