Actively Recruiting
Immediate Implant Placement in the Posterior Region Combining Sealing Socket Abutment and Peri-implant Socket Filling A Randomized Controlled Clinical Trial
Led by University of Liege · Updated on 2023-02-23
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two approaches for immediate dental implant placement in patients needing molar replacement in the upper or lower jaw. The study evaluates whether using a sealing socket abutment (SSA) with peri-implant socket filling better preserves the soft tissue contour around the implant compared to a standard healing abutment. Secondary goals include assessing changes in bone structure, soft tissue health, aesthetics, and patient-reported outcomes over time. Participants undergo minimally invasive tooth extraction followed by immediate implant placement using Straumann implants. The socket is filled with a bone graft material, and patients are randomly assigned to receive either a conventional healing abutment with collagen matrix closure or a customized SSA made chair-side using composite shaping and polishing. Antibiotics, anti-inflammatories, and oral hygiene instructions are provided. After three months, the abutments are removed, implant integration checked, and final zirconia crowns placed, replicating the abutment design. Participants will be monitored with follow-up visits at 7-10 days, 3 months, 6 months, and 12 months after surgery. Evaluations include standardized radiographs, 3D imaging to assess bone changes, soft tissue measurements such as probing depth and bleeding, aesthetic assessments, and patient questionnaires. The primary outcome is the change in soft tissue contour over one year, with ongoing monitoring of bone remodeling and soft tissue health to understand the implant's effects and patient satisfaction.
CONDITIONS
Brief Title
Immediate Implant Placement in the Posterior Region Combining Sealing Socket Abutment and Peri-implant Socket Filling.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Good general health (ASA I/II)
- Age 18 years or older
- Smokes fewer than 10 cigarettes per day
- Has one hopeless molar tooth needing replacement
- Healthy periodontal (gum) condition
- At least 2 mm of keratinized gingiva present
- Intact buccal bone wall
- Adequate plaque control (FMPS ≤ 25%)
- Sufficient bone quantity for immediate implant (apical bone height ≥ 5 mm or presence of interradicular septum)
- Provided written informed consent
You will not qualify if you...
- Auto-immune disease or immunocompromised status
- Uncontrolled diabetes
- Use of steroids or bisphosphonates
- Local or systemic infection requiring treatment before study
- Pregnancy or breastfeeding
- Alcoholism or chronic drug abuse
- Bone conditions needing angulated abutment
- Untreated local inflammation
- Presence of cysts
- Mucosal disease or oral lesions
- Prior local irradiation therapy
- Oral communication with sinus after tooth extraction
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day of surgery plus approximately 10 to 12 days post-operative care
Participants undergo minimally invasive tooth extraction and immediate implant placement with either a conventional healing abutment or a customized socket seal abutment. Post-operative care includes antibiotics, anti-inflammatories, and oral hygiene instructions.
1 surgery visit and 1 follow-up visit 7 to 10 days after surgery (in-person)
Duration - 3 months
Participants receive implant treatment with the assigned abutment, followed by placement of a CAD-CAM zirconia crown at 3 months after implantation. The crown design reflects the type of abutment used.
1 visit at 3 months for abutment removal, implant check, and crown placement (in-person)
Duration - 9 months after crown placement
Participants have follow-up evaluations to assess soft tissue contour, bone remodeling, soft tissue health, esthetic outcomes, and patient-related outcomes.
Visits at 6 months and 12 months after surgery (in-person)
Trial Site Locations
Total: 1 location
1
CHU de Liège
Liège, Belgium, 4000
Actively Recruiting
Research Team
B
Bruno De Carvalho, DDS, Ms, PhD Fellow
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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