Actively Recruiting
Timing of Soft Tissue Grafting Following Immediate Implant Placement
Led by University Ghent · Updated on 2023-10-03
40
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Timing of Soft Tissue Grafting Following Immediate Implant Placement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 20 years old
- Good oral hygiene defined as full-mouth plaque score 64 25% (O'Leary et al. 1972)
- Presence of an incisor, cuspid or premolar in the maxilla that needs to be extracted for any reason with at least one neighboring tooth present
- At least 3 mm bone available at the apical or palatal aspect of the alveolus as assessed on CBCT to ensure primary implant stability
- Intact buccal bone wall at the time of extraction
- Written informed consent
You will not qualify if you...
- Pregnancy
- Systemic diseases
- Smoking
- Suppuration
-
1 mm gingival asymmetry between the failing and contralateral tooth
- Untreated periodontal disease; untreated caries lesions
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ghent University
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
Research Team
J
Jan Cosyn, Professor
CONTACT
L
Lorenz Seyssens, Phd candidate
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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