Clinical trial NCT05287152: Titanium Tacked Soft Tissue Stabilization : A Novel Technique For Free Gingival Graft Fixation
Official title: Titanium Tacked Soft Tissue Stabilization : A Novel Technique For Free Gingival Graft Fixation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lack of Keratinized Gingiva
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2022-03-18
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Using the titanium tacks in free gingival graft fixation instead of conventional suturing.
Primary purpose: DEVICE_FEASIBILITY

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.

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 .

Eligibility criteria: 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

Primary outcomes:
measure: evaluation of the amount of the free gingival graft contraction when being fixed using the titanium tacks( bone tacks)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty Od Dentistry - Cairo University
Study officials:
References:
citation: 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.
citation: 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.
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/s00784-017-2320-y. Epub 2017 Dec 23.
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. doi: 10.1902/jop.2005.76.9.1588.
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.
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: 10.1002/cap.10113. Epub 2020 Aug 13.