NCT05287152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2021

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

March 10, 2022

Last Update Submit

March 10, 2022

Conditions

Lack of Keratinized Gingiva

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

titanium tacks or pinsDEVICE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patients on chemotherapy
  • patients on radiotherapy
  • smokers
  • patients with bad oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Od Dentistry - Cairo University

Cairo, Egypt

Location

Related Publications (6)

  • 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.

    PMID: 29498129RESULT

  • 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.

    PMID: 29197438RESULT

  • 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.

    PMID: 29275490RESULT

  • 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.

    PMID: 16171452RESULT

  • 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.

    PMID: 31497932RESULT

  • 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.

    PMID: 32692900RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Using the titanium tacks in free gingival graft fixation instead of conventional suturing.
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A dentist in oral implantology department ( master degree)

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 18, 2022

Study Start

March 1, 2021

Primary Completion

December 6, 2021

Study Completion

January 2, 2022

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations

EG(1)