CBCT Assessment of Peri-Implant Marginal Bone Changes Following Adjunctive Local Ozone Therapy: A Randomized Split-Mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Marginal Bone Level Around Dental Implants
研究概览
简要总结
This study examined whether adding local gaseous ozone to standard dental implant treatment could reduce early bone loss around implants. Fifty adults requiring matched implants on opposite sides of the same jaw participated. Within each participant, matched implant sites were randomly assigned to ozone treatment or standard treatment without ozone. Ozone was applied to the prepared implant socket during surgery and to the peri-implant surgical site after suturing and on postoperative days 1, 3, 5, and 7. Changes in marginal bone levels from baseline to 6 months were assessed using cone-beam computed tomography (CBCT).
详细描述
This prospective, split-mouth randomized clinical trial was conducted at the Department of Periodontology, Faculty of Dentistry, Adıyaman University. Participants required implant placement at matched contralateral posterior sites within the same jaw. Within each participant, matched implant sites were randomly allocated to adjunctive local gaseous ozone treatment or standard treatment without ozone. Ozone was applied to the prepared implant socket during surgery and to the peri-implant surgical site after suturing and on postoperative days 1, 3, 5, and 7. Fifty participants were enrolled; two were lost to follow-up, and 48 participants with 152 implants completed the study. The final analysis included 76 ozone-treated and 76 control implants. The primary outcome was the change in peri-implant marginal bone level from baseline to 6 months, assessed using cone-beam computed tomography at the buccal, palatal/lingual, mesial, and distal implant surfaces. The outcome assessor was blinded to treatment allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The radiographic outcome assessor was blinded to treatment allocation. The operating surgeon was not blinded because of the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 to 65 years.
- •Systemically healthy individuals.
- •Ability to comply with the study procedures and follow-up visits.
- •Requirement for implant placement at matched contralateral posterior sites within the same jaw.
- •Healed edentulous sites suitable for conventional implant placement.
- •Adequate alveolar bone volume for placement of implants measuring 3.5-4.0 mm in diameter and 8-12 mm in length without the need for advanced bone augmentation, with at least 1.5 mm of surrounding bone.
- •Initial soft-tissue thickness of at least 2 mm and keratinized mucosal width of at least 2 mm at the implant sites.
- •Provision of written informed consent.
排除标准
- •Systemic diseases or medical conditions contraindicating implant surgery.
- •Pregnancy.
- •Active oral infection or advanced periodontal disease.
- •Insufficient bone volume requiring advanced bone augmentation.
- •Incomplete healing at the intended implant site following recent tooth extraction.
- •Previous implant failure at the intended implant site.
- •Any contraindication to ozone therapy.
研究组 & 干预措施
Gaseous Ozone Application
Within each participant, one or more matched implant sites were randomly allocated to adjunctive local gaseous ozone treatment. Ozone was applied to the surgically prepared implant socket before implant placement and to the peri-implant surgical site after suturing and on postoperative days 1, 3, 5, and 7. All sites also received standard surgical and postoperative care.
干预措施: Gaseous Ozone Application (Procedure)
Conventional Implant Placement
Within each participant, the corresponding contralateral matched implant site or sites were allocated to the control treatment. These sites received conventional implant placement and standard postoperative care without ozone application at any time point.
干预措施: Conventional Implant Placement (Procedure)
结局指标
主要结局
Change in Marginal Bone Level Around Dental Implants
时间窗: Baseline and 6 months after implant placement
Using cone-beam computed tomography (CBCT), the vertical distance from the implant shoulder to the first bone-to-implant contact was measured in millimeters at the buccal, palatal/lingual, mesial, and distal surfaces at baseline and 6 months. For each surface, marginal bone level change was calculated as the 6-month distance minus the baseline distance; positive values indicated greater marginal bone loss. Combined buccolingual and mesiodistal measurements were calculated by averaging the corresponding surface measurements. Changes were compared between matched ozone-treated and control implant sites.
次要结局
未报告次要终点
研究者
Zeliha Başak Çakır Erdil
Research Assistant in Periodontology
Adiyaman University