A COMPARATIVE EVALUATION OF CRESTAL BONE LEVELS AROUND ENDOSSEOUS IMPLANTS WITH AND WITHOUT PHOTOBIOSTIMULATION: A CONE BEAM COMPUTED TOMOGRAPHY BASED RANDOMIZED CLINICAL TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Dental implants have become the gold standard for the rehabilitation of edentulous sites, owing to their high success rates and ability to restore both function and esthetics. However, early crestal bone remodelling remains a critical determinant of long-term implant stability. Loss of crestal bone compromises osseointegration, prosthetic longevity, and esthetic outcomes, making it a key parameter in implant research and clinical practice.
Photobiostimulation (PBS), delivered via low-level laser or light-emitting diodes, has emerged as a promising adjunctive modality to enhance peri-implant healing. PBS operates through the absorption of red to near-infrared light (600-1000 nm) by mitochondrial chromophores, leading to increased ATP production, modulation of reactive oxygen species, and activation of transcription factors. These cellular events promote osteoblastic activity, angiogenesis, and soft tissue repair.
Recent randomized controlled trials and systematic reviews have reported that photobiostimulation may improve implant stability, reduce crestal bone loss, and accelerate soft tissue healing. A systematic review and meta-analysis concluded that photobiostimulation significantly enhances implant stability and reduce crestal bone loss in healed sites. Similarly, randomized double-blind clinical studies demonstrated improved bone density and reduced inflammation around implants following photobiostimulation.
Radiographic evaluation, particularly using cone beam computed tomography(CBCT), provides a three-dimensional and quantitative assessment of peri-implant bone changes. The studies employing CBCT have shown that photobiostimulation can positively influence crestal bone density after implant placement. Photobiostimulation enhances alveolar bone repair by reducing pain and inflammation, stimulating angiogenesis, and accelerating new bone matrix formation-supporting ridge height and thickness.
While preliminary evidence supports photobiostimulation’s benefits, the scarcity of prospective clinical trials using CBCT leaves unanswered questions about its multidimensional effects on crestal bone levels, bucco-lingual dimensional stability, and bone density. This prospective, CBCT-controlled trial fills this critical evidence gap with comprehensive peri-implant bone assessments.
Therefore, the purpose of this study is to comparatively evaluate the effect of photobiostimulation on peri-implant crestal bone levels, bucco-lingual dimensional stability, and peri-implant bone density around endosseous implants using CBCT. Specifically, radiographic changes will be assessed to determine differences between implants treated with photobiostimulation (intervention group) and those without photobiostimulation (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age range 18-70 years Single missing anterior or posterior tooth with an adequate width and height of edentulous space available for the placement of implant.
- •Systemically healthy patients ASA Grade I and II (American Society of Anesthesiology).
- •Healed alveolar ridge (at least 3 months after tooth extraction).
- •Adjacent tooth intact with aesthetically and functionally good restoration.
排除标准
- •Patients with systemic conditions affecting bone metabolism, such as diabetes mellitus, osteoporosis, malignancy, renal or liver dysfunction, endocrine disorders, or those receiving bisphosphonate therapy.
- •Patients with severe parafunctional habits (e.g., bruxism).
- •Pregnant or lactating women.
- •Patients unable to maintain proper oral hygiene.
- •Presence of any pathologic condition in the area intended for implant placement.
- •Patients with tobacco/smoking habits, psychological disorders, or unrealistic expectations regarding treatment outcomes.
- •Patients undergoing or with a history of chemotherapy or radiotherapy.
- •Patients on medications known to alter bone metabolism.
- •Patients unwilling to provide informed consent to participate in the study.
研究者
DR RAGHAVENDRA METRI
Maharashtra Institute of Dental Sciences and Research