Clinical trial NCT06065254: Efficacy of Gingival Grafts During the Implantation Process on the Peri-implant Mucosa
Official title: Efficacy of Gingival Grafts During the Implantation Process in the Increasing of Peri-implant Keratinized Tissue Width and Soft Tissues Thickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Transplants
Keywords: Keratinized Mucosa
Connective Tissue Graft
Free Gingival Graft
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: The width of the keratinized gingiva
timeFrame: after 1 month and 3 months
measure: The thickness of the peri-implant soft tissues
timeFrame: after 1 month and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
affiliation: MSc student in Periodontology Departement, University of Damascus
name: Ahmad Alshouaa, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Periodontology, Department of Periodontology, University of Damascus
name: Mohammed Alsabbagh
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.