Randomized Study Comparing Three Soft-Tissue Techniques for Immediate Implant Placement in the Front Upper Jaw
Led by University Ghent · Updated on 2026-01-09
54
Participants Needed
1
Research Sites
260 weeks
Total Duration
AI-Summary
What this Trial Is About
This research evaluates three different soft-tissue augmentation methods for patients receiving a single immediate implant placement in the front upper jaw premaxilla. The study aims to find which method best prevents soft tissue loss around the implant one millimeter below the implant shoulder. It compares conventional connective tissue grafting with two newer techniques, scarf connective tissue graft and the dual zone concept, in a randomized controlled trial involving adults with good oral health. The study is led by University Ghent and involves 54 patients randomly assigned to one of the three treatment groups.
All participants receive immediate implant placement combined with socket grafting. The three groups differ in their soft-tissue augmentation approach the conventional method places a connective tissue graft inside a pouch on the buccal side the scarf graft fixes a smaller tissue graft directly onto the buccal mucosa without a pouch and the dual zone technique condenses bone material up to the soft tissue margin without using a connective tissue graft. After implant placement, a healing abutment is installed and replaced by a provisional crown two days later. Sutures are managed depending on the group and surgical needs.
Participants are evaluated through cone-beam CT scans, clinical measurements, intra-oral scans, and photos at baseline and follow-ups at one and five years. The main outcome is successful regeneration measured by tissue maintenance at the specified level. Additional outcomes include bone loss, soft tissue thickness, patient pain reports, oral health indicators, and esthetic scores. Data analysis uses statistical tests to compare results across groups, with safety and esthetic results monitored over time.
CONDITIONS
Brief Title
Comparison of Three Transmucosal Augmentation Techniques in Immediate Implant Placement
Research Team
V
Véronique Christiaens, PhD
J
Jan Cosyn, PhD
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Good oral hygiene defined as full-mouth plaque score C= 25%
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 (type I) or limited buccal bone dehiscence (type IIa or IIb) 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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 1 week
Participants receive immediate implant placement with one of three soft-tissue augmentation techniques: conventional connective tissue graft in a buccal pouch, scarf connective tissue graft fixed onto the buccal mucosa, or bone material condensed up to the buccal soft tissue margin. A healing abutment is installed and replaced by a provisional implant crown 2 days later. Sutures are removed about 1 week after surgery when applicable.
1 surgery visit and follow-up visits within 1 week
Follow-up
Duration - 5 years
Participants have clinical and imaging assessments to evaluate tissue changes, esthetic outcomes, and patient-reported results at 1 and 5 years after treatment.
Multiple follow-up visits including assessments at 1 year and 5 years
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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