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CompletedNCT06065254Updated Oct 3, 2023

Efficacy of Gingival Grafts During the Implantation Process on the Peri-implant Mucosa

An interventional study of Efficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness and Efficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness in Dental Implants and Transplants, sponsored by Damascus University. Completed at 1 site in Syria. Open to participants aged 21 Years to 83 Years. Per ClinicalTrials.gov, last updated 2023-10-03.

Sponsored by Damascus University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled May 2022, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
21 Years to 83 Years
Sex
All
01

Study 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.

Read the detailed description

The presence of adequate width of the keratinized gingiva may be necessary in some special cases such as the presence of fixed prostheses on the teeth with sublingual margins or peri implants. There is an association between insufficiency of the keratinized tissues peri implants with greater plaque accumulation, signs of inflammation, soft tissue recession, and loss of attachment. The sample will consist of 33 dental implant sites and divide randomly into three groups: Group I (Experiential, n=11): FGG; Group II: (Experiential, n=11): CTG; and Group III: (Control, n=11): No procedure will be done to improve the quality of the peri-implant tissues. The width of the keratinized gingiva will be measured preoperative with a UNC-15 and the thickness of the peri-implant soft tissues will be measured clinically by direct transgingival propping method. These measurements will be repeated after 1 and 3 months.

02

Conditions studied

  • Dental Implants
  • Transplants

Keywords

  • Keratinized Mucosa
  • Connective Tissue Graft
  • Free Gingival Graft
03

In context

Lead sponsor

Damascus University is the lead sponsor of 210 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 83 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. heavy smokers (more than 10 cigarettes per day)
  2. uncontrolled diabetes or other systemic diseases.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Free gingival graft

    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

  • Experimental
    Connective tissue graft

    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

  • Other
    No grafts will be applied.

    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

  • OtherEfficacy of free gingival grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness

    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.

  • OtherEfficacy of connective tissue grafts during in the increasing of peri-implant keratinized tissue width and soft tissues thickness

    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.

  • OtherNo types of grafts will be made to improve the quality of the peri-implant mucosa

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: after 1 month and 3 months

  2. 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.

    Time frame: after 1 month and 3 months

07

Study locations

1 site
  • Damascus University
    Damascus, Syria
08

References and documents

Publications

  • 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. PubMed 33279377 ↗
  • 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. PubMed 33047372 ↗
  • 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. PubMed 31875168 ↗
  • 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. PubMed 23342350 ↗
  • 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. PubMed 24641003 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2022 to primary completion in Feb 2023, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 27, 2023
First posted
Oct 3, 2023
StartActual
May 10, 2022
Primary completionActual
Feb 14, 2023
CompletionActual
Aug 25, 2023
Last update
Oct 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06065254
Responsible party
Sponsor
First posted
Oct 3, 2023
Start date
May 10, 2022
Primary completion
Feb 14, 2023
Completion
Aug 25, 2023
Last update
Oct 3, 2023

Study contacts

Ahmad Alshouaa, MSc
principal investigator · MSc student in Periodontology Departement, University of Damascus
Mohammed Alsabbagh
study chair · Professor of Periodontology, Department of Periodontology, University of Damascus

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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