Alveolar Bone Loss, Bone Expansion, Jaw, Edentulous, Partially, Osseodensification
Conditions
Keywords
osseodensification, Dental implants, Implant-site preparation, Insertion torque, Narrow alveolar ridge, Alveolar ridge expansion, Micro Castroviejo bone caliper
Brief 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
Detailed description
This study used a prospective, single-arm, non-randomized interventional design to assess immediate alveolar ridge-width changes following osseodensification-assisted implant-site preparation. Eligible adult participants had healed edentulous sites requiring dental implant placement and presented with limited horizontal alveolar ridge width. Implant sites were located in either the maxilla or mandible and included anterior and posterior regions. Preoperative CBCT examination was performed for implant planning and assessment of ridge dimensions. During surgery, local anesthesia was administered and a full-thickness mucoperiosteal flap was reflected. Baseline ridge width was measured directly using standardized Micro Castroviejo bone calipers at the crestal level and at 5 mm and 10 mm apical to the crest. Implant-site preparation began with a pilot drill, followed by sequential osseodensification burs operated in counterclockwise densifying mode under copious irrigation. After completion of the osteotomy and before implant insertion, ridge-width measurements were repeated at the same predefined reference levels. The primary assessment was the within-site difference between the post-osseodensification and baseline clinical measurements at each level. Dental implants were subsequently placed, and primary mechanical stability was assessed using insertion torque. Postoperative events were recorded during the scheduled follow-up period. Some participants contributed more than one implant site. Enrollment therefore refers to the number of participants, whereas ridge-width and implant-related measurements were recorded at the implant-site level.
Interventions
PROCEDUREDensah burs (Osseodensification Technique)
Dental implant osteotomies were prepared using sequential osseodensification burs operated in counterclockwise densifying mode under copious irrigation. The burs were advanced using a controlled pumping motion according to the study protocol. Ridge width was measured immediately before and after completion of the osteotomy at three predefined levels, followed by dental implant placement and insertion-torque recording.
Sponsors
University of Science and Technology, Yemen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study used a prospective, single-arm, non-randomized interventional design. All enrolled participants underwent dental implant-site preparation using the osseodensification technique. No conventional-drilling or alternative ridge-expansion comparison group was included. Alveolar ridge width was measured within the same implant site immediately before and immediately after osseodensification-assisted osteotomy preparation. Measurements were obtained at the crestal level and at 5 mm and 10 mm apical to the crest. Multiple implant sites were permitted within the same participant.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alveolar Ridge Width Following Osseodensification | Intraoperative assessment: immediately before and immediately after osseodensification during the same surgical procedure | Change in alveolar ridge width, measured in millimeters, using standardized Micro Castroviejo bone calipers at three predefined reference levels: (1) the crestal bone level, (2) 5 mm apical to the crest, and (3) 10 mm apical to the crest. Measurements were obtained immediately before osteotomy preparation and immediately after completion of osseodensification-assisted osteotomy preparation, before implant insertion. The outcome was calculated separately at each level as the post-osseodensification measurement minus the corresponding baseline measurement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insertion Torque at Dental Implant Placement | Intraoperative assessment at the time of implant placement. | Primary mechanical implant stability was assessed by recording the maximum insertion torque, measured in Newton-centimeters (Ncm), at the time of dental implant placement following osseodensification-assisted osteotomy preparation. |
| Occurrence of Postoperative Clinical Complications | From the surgical procedure through the 12-week postoperative follow-up period. | The occurrence of recorded postoperative clinical events was assessed after implant placement. Events included pain, edema, infection, paresthesia, supuration, and other clinically documented complications. Each event was recorded using the prespecified study definitions and reported using the number of participants and implant sites with available follow-up data. |
Countries
Yemen
Outcome results
None listed