Osseodensification for Narrow Alveolar Ridge Expansion
Yemen35 participantsStarted 2025-02-01
Plain-language 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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Alveolar Ridge Width Following Osseodensification
Timeframe: Intraoperative assessment: immediately before and immediately after osseodensification during the same surgical procedure
Trial details
NCT IDNCT07436533
SponsorUniversity of Science and Technology, Yemen