A Split-Mouth Randomized Controlled Trial Comparing Soft Tissue Healing and Crestal Bone Levels Around Photo-Functionalized Versus Non-Functionalized Dental Implants in Patients with Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Soft Tissue Healing
研究概览
简要总结
This study is a split-mouth randomized controlled clinical trial designed to evaluate and compare soft tissue healing and crestal bone level changes around photo-functionalized (UV-treated) and non-functionalized dental implants in controlled Type II diabetic patients. A total of 9 patients requiring at least two immediate implants were selected, resulting in 18 implant sites. Each patient received one UV-treated implant and one non-treated implant on opposite sides of the dental arch. Soft tissue healing was clinically assessed on Days 0, 3, 6, and 15, while crestal bone levels were measured radiographically using RVG at baseline, 2 months, and 4 months post-placement. The study aims to determine the effectiveness of photofunctionalization in enhancing early soft and hard tissue healing in diabetic individuals, with the goal of improving implant outcomes in this medically compromised group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Minimum of two teeth indicated for extraction on each side of the arch.
- •Age between 30 to 59 year controlled diabetic status: HbA1c : 6.5 percent to 8.0 percent Fasting glucose : 90 to 130 mg per dl postprandial glucose : less than 180 mg per dl Nonsmokers Presence of functional opposing dentition.
排除标准
- ••Individuals with uncontrolled systemic disease like hypertension.
- ••Patients presenting abuse of drugs or alcohol, use of tobacco.
- ••Patients presenting with handicap condition that would adversely affect the capacity to maintain satisfactory oral hygiene or complete the study protocol.
- ••Patient with immunocompromised conditions, including HIV.
结局指标
主要结局
Soft Tissue Healing
时间窗: Soft Tissue Healing | Clinical evaluation of soft tissue healing- Day 0 (baseline), Day 3, Day 6, and Day 15 | Crestal Bone Level Changes | Radiographic assessment of bone levels - at baseline (implant placement), 2 months, and 4 months postoperatively.
Clinical evaluation of soft tissue healing around photofunctionalized and non-photofunctionalized implants.
时间窗: Soft Tissue Healing | Clinical evaluation of soft tissue healing- Day 0 (baseline), Day 3, Day 6, and Day 15 | Crestal Bone Level Changes | Radiographic assessment of bone levels - at baseline (implant placement), 2 months, and 4 months postoperatively.
Assessed on Day 0 (baseline), Day 3, Day 6, and Day 15 using standardized clinical parameters (e.g., redness, swelling, bleeding).
时间窗: Soft Tissue Healing | Clinical evaluation of soft tissue healing- Day 0 (baseline), Day 3, Day 6, and Day 15 | Crestal Bone Level Changes | Radiographic assessment of bone levels - at baseline (implant placement), 2 months, and 4 months postoperatively.
Crestal Bone Level Changes
时间窗: Soft Tissue Healing | Clinical evaluation of soft tissue healing- Day 0 (baseline), Day 3, Day 6, and Day 15 | Crestal Bone Level Changes | Radiographic assessment of bone levels - at baseline (implant placement), 2 months, and 4 months postoperatively.
Radiographic assessment of bone levels around the implants using Radiovisiography (RVG).
时间窗: Soft Tissue Healing | Clinical evaluation of soft tissue healing- Day 0 (baseline), Day 3, Day 6, and Day 15 | Crestal Bone Level Changes | Radiographic assessment of bone levels - at baseline (implant placement), 2 months, and 4 months postoperatively.
Measurements taken at baseline (implant placement), 2 months, and 4 months postoperatively.
时间窗: Soft Tissue Healing | Clinical evaluation of soft tissue healing- Day 0 (baseline), Day 3, Day 6, and Day 15 | Crestal Bone Level Changes | Radiographic assessment of bone levels - at baseline (implant placement), 2 months, and 4 months postoperatively.
次要结局
- Comparison between Test and Control Sites (Split-Mouth)(Comparison of healing outcomes between the UV-treated (photofunctionalized) and non-treated implants within the same patient.)
研究者
ANKITA RAMESH GOMARE
Santosh deemed to be university, Ghaziabad