Expansion of Narrow Alveolar Ridges Using Osseodensification Burs for Dental Implant Placement: A Prospective Single-Arm Interventional Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Alveolar Ridge Width Following Osseodensification
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
osseodensification Group
Participants with healed edentulous sites and limited horizontal alveolar ridge width underwent dental implant-site preparation using the osseodensification technique. Baseline ridge-width measurements were obtained using standardized Micro Castroviejo bone calipers at the crestal level and at 5 mm and 10 mm apical to the crest. Following osseodensification-assisted osteotomy preparation, ridge-width measurements were repeated at the same reference levels before implant insertion.
干预措施: Densah burs (Osseodensification Technique) (Procedure)
结局指标
主要结局
Change in Alveolar Ridge Width Following Osseodensification
时间窗: 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.
次要结局
- Insertion Torque at Dental Implant Placement(Intraoperative assessment at the time of implant placement.)
- Occurrence of Postoperative Clinical Complications(From the surgical procedure through the 12-week postoperative follow-up period.)
研究者
Essamali Alsaidi
Master's Degree Candidate, F aculty of Dentistry
University of Science and Technology, Yemen