Clinical and Radiographic Evaluation of Topical Vitamin D Application on Immediate Dental Implants: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Implant Stability (ISQ)
研究概览
简要总结
This study evaluates the clinical and radiographic outcomes of topical vitamin D application on immediate dental implants in patients undergoing single-rooted tooth extraction in the anterior mandibular region.
详细描述
This randomized clinical trial investigates the clinical and radiographic outcomes of topical vitamin D application on immediate dental implants in patients undergoing single-rooted tooth extraction in the anterior mandibular region. Osseointegration, the direct structural and functional connection between bone and implant surface, is a critical factor in implant success. Recent studies suggest that vitamin D3 plays a significant role in bone metabolism, promoting osteoblast differentiation and enhancing mineralization. The aim of this study is to evaluate whether the adjunctive use of topical vitamin D3 gel can improve implant stability, peri-implant soft tissue health, and bone density around immediate dental implants.
Surgical Protocol:
- All surgical procedures were performed under strict infection control protocols at the Faculty of Dentistry, Suez Canal University.
- Patients rinsed with 0.1% chlorhexidine (Hexitol antiseptic mouthwash) for one minute before the procedure.
- The perioral area was disinfected using 10% povidone-iodine (Betadine).
- Local anesthesia was administered using 4% articaine hydrochloride with 1:100,000 epinephrine (Artinibsa) via the infiltration technique.
- Atraumatic tooth extractions were performed using periotomes and anterior forceps, preserving the surrounding alveolar bone.
- The dimensions of the extraction socket and residual bone were evaluated using a periodontal probe to ensure compatibility with the implant size.
- Osteotomy preparation followed a standardized protocol using sequential drills at 950-1100 rpm with 35 Ncm torque under copious irrigation to prevent overheating and bone necrosis.
- Study Group: Sterile vitamin D3 (calcitriol) gel was applied to both the implant surface and the osteotomy site immediately before implant placement.
- Control Group: No additional adjuncts were applied before implant placement.
- ROOTT R-line implants were selected based on socket dimensions.
- Implants were inserted into fresh extraction sockets, and proper alignment was meticulously confirmed to ensure ideal positioning.
Postoperative and Follow-up Evaluations:
- Clinical Assessments:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both genders.
- •Middle-aged adults (from 21 years to 40 years).
- •Healthy American Society of Anesthesiologists patients (ASA I).
- •Patients with teeth or roots indicated for extraction at the lower anterior region.
排除标准
- •Pregnant or lactating females.
- •Patients with parafunctional or bad oral habits such as bruxism or smoking (more than 10 cigarettes per day).
- •Patients with bad oral hygiene.
- •Patients with severe periodontal diseases (severe vertical or horizontal bone loss).
- •Pathological changes or infections related to teeth indicated for immediate implant placement.
研究组 & 干预措施
Control Group
12 implants were placed immediately after teeth extraction.
干预措施: Immediate Dental Implant Placement without Adjunctive Treatments (Procedure)
Vitamin D Group
12 implants were placed immediately after teeth extraction, combined with topical vitamin D gel application.
干预措施: Immediate Dental Implant Placement with Topical Vitamin D Gel Application (Procedure)
结局指标
主要结局
Implant Stability (ISQ)
时间窗: Baseline, 3, and 6 months postoperatively
Implant stability was measured using the Osstell ISQ device, providing precise, non-invasive, and objective assessments for monitoring osseointegration. A SmartPeg was securely attached to the implant, and a probe connected to the device was positioned at a right angle toward the implant. The Implant Stability Quotient (ISQ) was measured on a scale from 1 to 100, with values above 70 indicating high stability, 60-69 indicating medium stability, and values below 60 suggesting low stability. Stability was assessed immediately after surgery and then reassessed at 3 and 6 months.
Bone Density
时间窗: Baseline, 3 and 6 months postoperatively
Radiographic evaluations were conducted using direct digital periapical radiographs, captured with the KaVo Scan eXam™ One system and Rinn XCP device. Radiographs were taken immediately postoperatively, and at 3 and 6 months. Bone density around the implants was analyzed using IDRISI Kilimanjaro software, which measured grayscale values to quantify density. Bone density was quantified on a 255-point grayscale, with 0 representing black regions and 255 representing white regions. Two zones were assessed: the osseointegration zone adjacent to the implant and the surrounding bone. This approach provided precise monitoring of bone density changes over time.
次要结局
- Visual Analogue Scale for Pain (VAS)(Days 1, 3, and 7 postoperatively)
- Bleeding Index (BI)(3 and 6 months postoperatively)
- Peri-implant Probing Depth (PD)(3 and 6 months postoperatively)
研究者
Bassem M. Ayyad
Bassem M. Ayyad
Suez Canal University