NCT06065254

Brief Summary

This study aims to compare the changes in the peri-implant mucosa during the application of two soft tissue grafting methods, which are free gingival graft (FGG) and connective tissue graft (CTG) taken from the palatine in terms of the width of the keratinized mucosa and the thickness of the peri-implant soft tissues.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 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

May 10, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 27, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

September 27, 2023

Last Update Submit

September 27, 2023

Conditions

Dental ImplantsTransplants

Keywords

Keratinized MucosaConnective Tissue GraftFree Gingival Graft

Outcome Measures

Primary Outcomes (2)

  • The width of the keratinized gingiva

    The width of the keratinized gingiva will be measured using a UNC-15 probe from the middle of the alveolar process at the site studied to the mucogingival junction, which was determined by the rollover technique.

    after 1 month and 3 months

  • The thickness of the peri-implant soft tissues

    The thickness of the peri-implant soft tissues will be measured clinically by the direct transgingival propping method.

    after 1 month and 3 months

Study Arms (3)

Free gingival graft

EXPERIMENTAL

Free gingival graft will be applied and and followed for 3 months

Other: Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness

Connective tissue graft

EXPERIMENTAL

Connective tissue graft will be applied and and followed for 3 months

Other: Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness

No grafts will be applied.

OTHER

No grafts of any types will be applied.

Other: No types of grafts will be made to improve the quality of the peri-implant mucosa

Interventions

Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thicknessOTHER

Two vertical incisions will be made in the previously elevated flap against the placed implant , where these two incisions will be 10 mm apart from each other, and the free graft to will be placed in this distance (10 x 10 mm). The graft will be obtained from the donor site (the hard palate), and will be thinned to obtain a regular graft with the required thickness. After that, the graft will be moved to its correct place accurately, while avoiding leaving a distance between the graft and the tissue underneath, and the graft will be sutured well to ensure its stability and correct placement.

Free gingival graft
Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thicknessOTHER

Vertical incisions will not be made in the previously elevated flap against the placed implant, where there is no need to suture the flap apically of the grafting place because the graft will be covered with it after fixing it in place. The area will be washed with the serum to remove the clot before fixing the graft.The graft will be obtained from the donor site according to the previously mentioned method. Then the epithelium will be removed to leave the connective tissue underneath, and then the graft will be moved to its place (buccally dental implant site) and the flap will be sutured over it.

Connective tissue graft
No types of grafts will be made to improve the quality of the peri-implant mucosaOTHER

The simple suturing of the two surgical incisions will be done after the completion of the dental implant process, with no procedure will be made to improve the quality of the peri-implant mucosa.

No grafts will be applied.

Eligibility Criteria

Age21 Years - 83 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who have lost posterior teeth (premolars or molars).
  • A decrease in the amount of keratinized gingiva (less than 2 mm from the alveolar process to the mucogingival junction).
  • good oral health (plaque index ≤1).

You may not qualify if:

  • heavy smokers (more than 10 cigarettes per day)
  • uncontrolled diabetes or other systemic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damascus University

Damascus, Syria

Location

Related Publications (5)

  • De Angelis P, De Angelis S, Passarelli PC, Liguori MG, Pompa G, Papi P, Manicone PF, D'Addona A. Clinical comparison of a xenogeneic collagen matrix versus subepithelial autogenous connective tissue graft for augmentation of soft tissue around implants. Int J Oral Maxillofac Surg. 2021 Jul;50(7):956-963. doi: 10.1016/j.ijom.2020.11.014. Epub 2020 Dec 2.

    PMID: 33279377BACKGROUND

  • Schmitt CM, Bruckbauer P, Schlegel KA, Buchbender M, Adler W, Matta RE. Volumetric soft tissue alterations in the early healing phase after peri- implant soft tissue contour augmentation with a porcine collagen matrix versus the autologous connective tissue graft: A controlled clinical trial. J Clin Periodontol. 2021 Jan;48(1):145-162. doi: 10.1111/jcpe.13387. Epub 2020 Nov 12.

    PMID: 33047372BACKGROUND

  • Raoofi S, Asadinejad SM, Khorshidi H. Evaluation of Color and Width of Attached Gingiva Gain in Two Surgical Techniques: Free Gingival Graft and Connective Tissue Graft Covered By Thin Mucosal Flap, a Clinical Trial. J Dent (Shiraz). 2019 Dec;20(4):224-231. doi: 10.30476/DENTJODS.2019.44916.

    PMID: 31875168BACKGROUND

  • Happe A, Stimmelmayr M, Schlee M, Rothamel D. Surgical management of peri-implant soft tissue color mismatch caused by shine-through effects of restorative materials: one-year follow-up. Int J Periodontics Restorative Dent. 2013 Jan-Feb;33(1):81-8. doi: 10.11607/prd.1344.

    PMID: 23342350BACKGROUND

  • Thoma DS, Buranawat B, Hammerle CH, Held U, Jung RE. Efficacy of soft tissue augmentation around dental implants and in partially edentulous areas: a systematic review. J Clin Periodontol. 2014 Apr;41 Suppl 15:S77-91. doi: 10.1111/jcpe.12220.

    PMID: 24641003BACKGROUND

Study Officials

  • Ahmad Alshouaa, MSc

    MSc student in Periodontology Departement, University of Damascus

    PRINCIPAL INVESTIGATOR

  • Mohammed Alsabbagh

    Professor of Periodontology, Department of Periodontology, University of Damascus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 3, 2023

Study Start

May 10, 2022

Primary Completion

February 14, 2023

Study Completion

August 25, 2023

Last Updated

October 3, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

SY(1)