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