Immediate implant placement with alveolar ridge preservation or partial root retention: a randomized controlled clinical trial assessing biological long-term complications, three-dimensional ridge alterations and patient-reported outcome measures
- Conditions
- Patients with a hopeless tooth in need of single tooth implant replacement between canine and canine in the upper jaw.None
- Registration Number
- DRKS00014324
- Lead Sponsor
- Gemeinschaftspraxis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
Male and female, systemically healthy patients, at least 18 years of age, presenting hopeless teeth in need of single tooth implant replacement between canine and canine in the upper jaw
- Periodontally healthy conditions including the ability to achieve good oral hygiene and control gingivitis with FMPS and FMBS = 25% (full-mouth plaque (FMPS) and bleeding (FMBS) scores)
- No medication known to interfere with periodontal tissue health or healing.
- No pregnancy
- Ability to understand study procedures and to comply with them for the entire duration of the study. Ability and willingness to give written informed consent
- Presence of less than 50% of a hypothetically idealised buccal bone height relative to the vertical distance between the base of the extraction socket and the midpalatal alveolar bone margin extension based on digital cone beam computed tomography (CBCT) measurements.
- Patients smoking more than 20 cigarettes per day
- Participation in another clinical trial
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method on-inferiority of test versus control surgical intervention with respect to loss in marginal bone level after 1y post-implantation assessed on standardized periapical radiographs
- Secondary Outcome Measures
Name Time Method - Clinical assessment of plaque and bleeding, height of keratinized tissue, probing pocket depth (using dental probe and standard forms)<br>- Ridge contour changes (based on dental impressions)<br>- Pink esthetic score (based on photographs)<br>- Patient Reported Outcome Measures (PROMs) (based on standardized surveys)<br>