Dental Implantation Clinical Trial
— RCTOfficial title:
Immediate Implant Placement in the Posterior Region Combining Sealing Socket Abutment and Peri-implant Socket Filling.A Randomized Controlled Clinical Trial
The primary endpoint of this study is to compare the soft tissue contour changes after immediate implant placement combined to peri-implant socket filling with a sealing socket abutment (SSA) versus a standard healing abutment. The hypothesis is that the SSA better preserves the alveolar ridge profile in the cervical region compared to a conventional healing abutment. The secondary objectives aim to evaluate 3D hard tissue changes, peri-implant bone remodeling, soft tissue health, esthetic outcomes and the patients related outcome measures.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 1, 2026 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Good general health (ASA I/II), - More than 18 years old, - Smoker < 10c/day, one hopeless tooth, - Healthy periodontal condition, - Presence of at least 2 mm of keratinized gingiva - Intact buccal bone wall - Adequate plaque control (FMPS = 25%) - Adequate bone quantity allowing an immediate implant procedure (apical bone height of at - Least 5 mm or presence of interradicular septum) - Written consent provided Exclusion Criteria: - Auto-immune disease or immunocompromised patients - Uncontrolled diabetes - Use of steroids or biphosphonates - Local or systemic infection (medical treatment needed prior to entrance to the study) - Pregnancy or breastfeeding - Alcoholism or chronically drug abuse - Bone availability requiring an angulated abutment - Untreated local inflammation - Cyst - Mucosal disease or oral lesions - Local irradiation therapy - Oral communication with sinus after the extraction |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU de Liège | Liège |
Lead Sponsor | Collaborator |
---|---|
University of Liege |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Soft Tissue Contour from baseline to 3 months, 6 months and 1 year | Compare the soft tissue contour changes after immediate implant placement combined to peri-implant socket filling with a sealing socket abutment (SSA) versus a standard healing abutment. | 3 months, 6 months, 1 year | |
Secondary | 3D hard tissue changes | Assessment of bone dimension changes | Baseline, 1 year | |
Secondary | Peri-implant bone remodeling | Assessment of bone height changes | 3 months, 6 months, 1 year | |
Secondary | Soft tissue health changes assessed by Probing Pocket Depth | Assessed of probing depth | 3 months, 6 months, 1 year | |
Secondary | Soft tissue health changes assessed by Bleeding on Probing | Assessment of the bleeding percentage | 3 months, 6 months, 1 year | |
Secondary | Soft tissue health changes assessed by Plaque Index | Assessment of plaque percentage | 3 months, 6 months, 1 year | |
Secondary | Esthetic outcomes changes | Assessed by Pink Esthetic Score (Papilla presence, tissue contour, gingival level, alveolar process, colouring and texture) as well as intra-oral photographs | 10 days, 3 months, 6 months, 12 months | |
Secondary | Patients Related Outcome Measures | Assessed by questionnaire | 6 months, 1 year |
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