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Active Not Recruiting NCT07436533

Osseodensification for Narrow Alveolar Ridge Expansion

Conditions: Osseodensification, Bone Expansion, Alveolar Bone Loss, Jaw, Edentulous, Partially

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 35
Sponsor: University of Science and Technology, Yemen

Location: 60 Meters St., Madbah, University of Science and Technology Sanaa S

Summary

This prospective, single-arm, non-randomized interventional clinical study was designed to evaluate the immediate horizontal dimensional change in narrow alveolar ridges following osseodensification-assisted dental implant-site preparation. Eligible participants with healed edentulous sites in the maxilla or mandible underwent implant-site preparation using osseodensification burs operated in densifying mode. Alveolar ridge width was measured directly using standardized Micro Castroviejo bone calipers at three predefined levels: the crestal level and 5 mm and 10 mm apical to the crest. Measurements were obtained immediately before and immediately after osseodensification-assisted osteotomy preparation. The primary outcome was the within-site change in alveolar ridge width at the three measurement levels. Additional assessments included insertion torque at implant placement and recorded postoperative complications. The study included a single treatment group and did not include a conventional-drilling or alternative ridge-expansion comparison group

Eligibility Criteria

Inclusion Criteria: * Adults aged 18 years or older and within the upper age limit specified in the final ethics-approved protocol. * Healed edentulous sites involving single or multiple missing teeth in the maxillary or mandibular arches. * A post-extraction healing period of at least 6 months before implant placement. * Adequate vertical bone dimensions for dental implant placement, as assessed using CBCT. * Absence of active local infection or pathological lesions at the proposed implant site. * Clinical suitability for dental implant placement and osseodensification-assisted osteotomy preparation. * Ability and willingness to provide informed consent and attend the scheduled follow-up visits. * Maintenance of acceptable oral hygiene. * Alveolar ridge width of ≤8 mm at the crestal level, measured buccolingually, and considered to require horizontal expansion during implant-site preparation. * Implant sites classified as Misch D1-D4 according to the protocol-specified bone-quality assessment. Exclusion Criteria: * Acute or chronic infection or a pathological condition at the proposed implant site. * Severe buccal plate undercut or ridge concavity that precluded safe implant-site preparation. * Insufficient vertical bone height for the planned dental implant. * Inadequate interarch distance for implant-supported rehabilitation. * Severe parafunctional habits, including clinically significant bruxism or clenching. * Heavy smoking, defined as more than 10 cigarettes per day. * Use of medications considered likely to compromise bone healing according to the approved protocol, including relevant corticosteroid or antiresorptive therapy. * Uncontrolled systemic disease or a medical condition that could materially affect surgical healing or implant treatment. * History of radiotherapy to the head and neck or chemotherapy within the preceding 5 years. * Current pregnancy at the time of the surgical procedure. * Inability or unwillingness to provide informed consent or attend the required follow-up visits

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07436533). StuddyBuddy aggregates publicly available trial information.