NCT06101524

Brief Summary

The primary aim of this study is to evaluate the clinical results of free gingival graft and gingival unit graft by indirect method. To evaluate the 6-month results linearly and volumetrically using an intraoral scanner (TRİOS, 3Shape, Copenhagen, Denmark) (using measurements and on a plaster model).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

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

February 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 20, 2023

Last Update Submit

October 20, 2023

Conditions

Keywords

Free gingival greftFree gingival unitScanner

Outcome Measures

Primary Outcomes (2)

  • Keratinized gingival width

    The change in keratinized tissue width after free gingival graft and gingival graft unit operations was evaluated.

    İnitial and postoperative 6 months

  • Average gingival thickness change (mm)

    The change in average gingival thickness change after free gingival graft and gingival graft unit operations was evaluated.

    İnitial and postoperative 6 months

Study Arms (2)

Free Gingival greft Group

EXPERIMENTAL

Patients who are found to have keratinized mucosa insufficiency as a result of the examination, undergo free gingival graft to increase the keratinized mucosa. procedures will be done and you will be called for a check-up after 6 months. The keratinized tissue volume formed after the procedure will be evaluated.

Procedure: Free gingival unit, free gingival greft

Gingival Unit Greft Group

EXPERIMENTAL

Patients who are found to have keratinized mucosa insufficiency as a result of the examination, undergo gingival unit graft to increase the keratinized mucosa. procedures will be done and you will be called for a check-up after 6 months. The keratinized tissue volume formed after the procedure will be evaluated.

Procedure: Free gingival unit, free gingival greft

Interventions

The free gingival graft and the free gingival unit taken from the upper jaw palatal mucosa were sutured to the lower jaw anterior region.

Free Gingival greft GroupGingival Unit Greft Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are systemically healty,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü İmam University

Kahramanmaraş, Turkey (Türkiye)

Location

Related Publications (7)

  • Agarwal C, Tarun Kumar AB, Mehta DS. Comparative evaluation of free gingival graft and AlloDerm((R)) in enhancing the width of attached gingival: A clinical study. Contemp Clin Dent. 2015 Oct-Dec;6(4):483-8. doi: 10.4103/0976-237X.169838.

    PMID: 26681852BACKGROUND
  • Agudio G, Chambrone L, Selvaggi F, Pini-Prato GP. Effect of gingival augmentation procedure (free gingival graft) on reducing the risk of non-carious cervical lesions: A 25- to 30-year follow-up study. J Periodontol. 2019 Nov;90(11):1235-1243. doi: 10.1002/JPER.19-0032. Epub 2019 Jul 19.

    PMID: 31194255BACKGROUND
  • Arzouman A, Deas DE, Mills MP, Huynh-Ba G, Prihoda TJ, Mealey BL. Impact of different surgical protocols on dimensional changes of free soft tissue autografts: A randomized controlled trial. J Periodontol. 2021 Jan;92(1):45-53. doi: 10.1002/JPER.20-0033. Epub 2020 Oct 16.

    PMID: 32716061BACKGROUND
  • Cabanes-Gumbau G, Pascual-Moscardo A, Penarrocha-Oltra D, Garcia-Mira B, Aizcorbe-Vicente J, Penarrocha-Diago MA. Volumetric variation of peri-implant soft tissues in convergent collar implants and crowns using the biologically oriented preparation technique (BOPT). Med Oral Patol Oral Cir Bucal. 2019 Sep 1;24(5):e643-e651. doi: 10.4317/medoral.22946.

    PMID: 31422410BACKGROUND
  • Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.

    PMID: 21507033BACKGROUND
  • Cevallos CAR, de Resende DRB, Damante CA, Sant'Ana ACP, de Rezende MLR, Greghi SLA, Zangrando MSR. Free gingival graft and acellular dermal matrix for gingival augmentation: a 15-year clinical study. Clin Oral Investig. 2020 Mar;24(3):1197-1203. doi: 10.1007/s00784-019-02983-0. Epub 2019 Jul 12.

    PMID: 31300879BACKGROUND
  • De Bruyckere T, Cabeza RG, Eghbali A, Younes F, Cleymaet R, Cosyn J. A randomized controlled study comparing guided bone regeneration with connective tissue graft to reestablish buccal convexity at implant sites: A 1-year volumetric analysis. Clin Implant Dent Relat Res. 2020 Aug;22(4):468-476. doi: 10.1111/cid.12934. Epub 2020 Jul 19.

    PMID: 32686234BACKGROUND

Study Officials

  • Eda Çetin Özdemir

    Kahramanmaras Sutcu Imam University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 26, 2023

Study Start

February 1, 2022

Primary Completion

January 1, 2023

Study Completion

June 1, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

We have other studies using this data

Locations