Efficacy of Photobiomodulation (PBM) on stability and crestal bone remodelling in immediate implant placement following socket shielding technique: Randomised Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Impant Stability
研究概览
简要总结
Title
Efficacy of Photobiomodulation on stability and crestal bone remodelling in immediate implant placement following socket shielding technique: Randomised Controlled Clinical Trial
Introduction
Socket shielding was introduced to preserve buccal bone after extraction by leaving a thin root fragment as a barrier.
Photobiomodulation (PBM) uses low-level red or near-infrared light to accelerate tissue regeneration, reduce inflammation, and improve bone and soft tissue healing around implants.
Combining socket shielding with PBM aims to improve implant stability and maintain bone and aesthetics.
Problem Statement
Socket shield technique may face issues like shield exposure and root fragment resorption due to inflammation.
PBM can minimize inflammation and promote osseointegration.
Need for study
Limited literature compares bone changes and implant stability in socket shielding with and without PBM.
Aim
To evaluate and compare crestal bone remodelling and implant stability between conventional socket shielding and socket shielding with PBM.
Objectives
Compare implant stability quotients at baseline, 1 month, and 3 months.
Compare crestal bone remodelling at baseline and 6 months.
Hypothesis
Null: No difference between the two groups.
Research: PBM will improve stability and bone preservation.
Research Question
Will there be a difference in implant stability and crestal bone remodelling between conventional socket shielding and socket shielding with PBM in maxillary single-rooted teeth?
Sample Size
Final sample size: 22 subjects (11 per group).
Inclusion Criteria
Patients 20–60 years, ASA I, single-rooted maxillary teeth for extraction, intact buccal tissues, any periodontal phenotype.
Exclusion Criteria
Patients with systemic diseases, radiotherapy, active infection, teeth with alveolar fracture, or roots into sinus.
Methodology
Random allocation into experimental and control groups.
Informed consent, CBCT assessment, plaque control.
Socket shield preparation and implant placement.
Experimental group: PBM with diode laser (810 nm, 10 mW, 60 sec).
Suturing and follow-up.
Follow-up
Implant stability: 0, 1, 3 months.
Crestal bone levels: 6 months via CBCT.
PBM second session during suture removal.
Statistical analysis using ANOVA, t-test, or Friedman’s test.
Outcome
Expected to show improved implant stability and crestal bone preservation with PBM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient with age 20 – 60 years.
- •2.American Society of Anaesthesiologists (ASA) I category.
- •3.Bilateral or unilateral with one or more teeth advised for extraction in the maxillary single rooted teeth region.
- •4.Non-restorable carious lesion.
- •5.Fairly intact buccal periodontal tissues.
- •6.Any periodontal phenotype (thin or thick) was included.
排除标准
- •1.Patients subjected to radiotherapy in the head and neck.
- •2.ASA – II, III, IV, V patients.
- •3.Teeth with Periodontal disease, fracture involving the alveolus and mobile teeth.
- •4.Active local or systemic infection.
- •5.Roots extending into maxillary sinus.
结局指标
主要结局
Impant Stability
时间窗: Implant Stability at 0, 3, 6 months
次要结局
- Crestal bone remodelling(Basal line and 6th month)
研究者
Dr Reyya Arun Prakash
Vishnu Dental college