60 Meters St., Madbah, University of Science and Technology
Sanaa, S, (15201 - 13064), Yemen
NCT Number: NCT07436533
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
This study is active but is not currently recruiting participants.
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Sanaa, S, (15201 - 13064), Yemen
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Osseodensification-Assisted Implant-Site Preparation, Densah burs, Densifying osteotomy preparation, Non-subtractive drilling protocol, Osseodensification drilling technique
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Preoperative CBCT assessment and intraoperative baseline measurement before osseodensification.
Agreement between preoperative CBCT-derived alveolar ridge-width measurements and direct intraoperative baseline measurements obtained using Micro Castroviejo bone calipers was assessed at the crestal level and at 5 mm and 10 mm apical to the crest.
The comparison included paired differences, rank correlations, and descriptive Bland-Altman limits of agreement. The analysis assessed baseline measurement correspondence and did not compare postoperative caliper measurements with postoperative CBCT.
University of Science and Technology, Yemen
Other
Expansion of Narrow Alveolar Ridges Using Osseodensification Burs for Dental Implant Placement: A Prospective Single-Arm Interventional Clinical Study
Acronym: OD-RridgeExp
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