RecruitingNot ApplicableNCT05537545

Timing of Soft Tissue Grafting Following Immediate Implant Placement

A Randomized Controlled Trial on the Timing of Soft Tissue Grafting Following Immediate Implant Placement


Sponsor

University Ghent

Enrollment

40 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Patients undergoing single immediate implant placement (IIP) in the premaxilla will be invited to participate in this randomized controlled trial (RCT). Prior to surgery, a small- field low-dose cone beam computed tomography (CBCT) is taken to verify the integrity of the facial bone wall and an adequate amount of apical and palatal bone availability for implant anchorage. In all of the patients, a connective tissue graft (CTG) will be harvested and inserted into the buccal mucosa to increase soft tissue thickness around the immediately installed implant. However, included patients will be randomly allocated to either receive the CTG immediately after implant installation (Immediate soft tissue grafting, ISG = control group) or 3 months after implant installation (Delayed soft tissue grafting, DSG = test group). Forty sealed envelopes are prepared for that purpose, of which 20 are internally labeled as "DSG" and 20 as "ISG". Following IIP, a sealed envelope will be opened to reveal the treatment concept In both groups, a cutting implant is installed in an optimal 3D position. Socket grafting is performed with deproteinized bovine bone mineral to limit buccal bone resorption and to optimize soft tissue stability. In the ISG group, a pouch is made in the buccal mucosa using microsurgical instruments. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a CTG of about 1 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is brought into the pouch and fixed with two single sutures onto the buccal mucosa. Finally, a healing abutment is installed, which is replaced by a provisional implant crown 2 days later. In the DSG group, implant placement, socket grafting and installation of a provisional implant crown occur as described above. In contrast, a buccal pouch is performed 3 months after implant installation. Graft harvesting, adaptation and fixation are performed as described above. A small-field low-dose CBCT is taken at the 1-year and 5-year follow-up in order to measure buccal bone resorption as compared to the baseline dimensions in designated software.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This dental study is looking at the best timing for a soft tissue graft (a small gum surgery) when a dental implant is placed immediately after tooth extraction. Researchers want to find out whether doing the gum graft at the same time as the implant, or waiting a few months, gives better cosmetic and functional results. You may be eligible if: - You are 20 years old or older - You have good oral hygiene - You have a front or side tooth in the upper jaw that needs to be extracted, with at least one neighboring tooth present - Your bone structure around the extraction site is adequate for an implant You may NOT be eligible if: - You are pregnant - You smoke - You have systemic (whole-body) diseases - You have untreated gum disease, tooth decay, or active infection (suppuration) - There is an existing difference in gum levels between the failing and opposite tooth of more than 1 mm Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESoft tissue grafting

A pouch is made in the buccal mucosa using microsurgical instruments. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a CTG of about 1 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is brought into the pouch and fixed with two single sutures (Seralon 6/0, Serag Wiessner, Naila, Germany) onto the buccal mucosa.


Locations(1)

Ghent University

Ghent, Oost-Vlaanderen, Belgium

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NCT05537545


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