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

Dental Implants Clinical Trial

Official title:

Efficacy of Gingival Grafts During the Implantation Process in the Increasing of Peri-implant Keratinized Tissue Width and Soft Tissues Thickness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06065254
• Other study ID #: UDDS-Perio-01-2023
• Status: Completed
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: August 25, 2023

Study information

• Verified date: September 2023
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 25, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 83 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implants
• Transplants

Intervention

Other:
• Efficacy 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.
• Efficacy 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.
• No 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.

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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