"Deep Caries Management with Er:YAG Laser: A Multifaceted Randomized Controlled Trial Comparing Er Laser Technology with Conventional Methods for Predictive Deep Caries Management in Restorative Dentistry"
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- 1. Effects of Er
研究概览
简要总结
Comparative Assessment of Er
Laser Therapy Versus Conventional Methods in Deep Caries ManagementO
bjectives:
- To evaluate the antimicrobial effects of Erlaser therapy on cariogenic microorganisms and microbial load within therapeutic cavities compared to conventional methods (manual excavation and rotary methods).
- To compare patient experiences and objective assessments of Erlaser versus rotary bur methods in terms of excavation time, patient comfort, and acceptability.
- To analyze the longevity and clinical outcomes of restorations prepared with Erlaser cavities compared to conventional cavity preparation over a defined follow-up period.
- To investigate outcomes of direct pulp capping using Erlaser technology versus conventional methods in the management of deep caries.
- To assess the impact of adjunctive photobiomodulation with a diode laser alongside Erlaser therapy for managing deep caries lesions, with and without pulp involvement.
Primary Outcomes:
**1.**Reduction in microbial load
-
Patient comfort and procedural time
-
Restoration success rate over time
-
Pulp vitality in direct pulp capping
-
Success of photobiomodulation in lesion resolution
Timeline:
Immediate and short-term follow-up (within 1 week) for microbial reduction and patient comfort.
Regular follow-ups at 3 months, 6 months, 1 year, and 2 years for assessing restoration longevity, pulp vitality, and clinical outcomes of photobiomodulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with at least one deep carious lesion (class I occlusal decay and extending into dentin) in a permanent tooth.
- •Teeth testing normal to sensibility tests (tested with electric pulp tester and cold test)
- •Teeth having no visible changes in the radiograph at the apical area.
排除标准
- •Pregnant or lactating individuals.
- •Individuals with extensive tooth decay requiring endodontic treatment or tooth extraction.
- •Teeth testing abnormal to sensibility tests.
- •Participants with a history of previous laser treatment on the same tooth.
- •Participants with known allergies or hypersensitivity to any of the materials used in the study.
- •Participants with severe periodontal disease, active oral infections, or conditions affecting the oral mucosa.
- •Individuals with systemic health conditions or immunocompromised status that may affect the study outcomes.
- •Participants unable to provide informed consent or understand the study requirements due to language barriers, cognitive impairments, or any other reasons.
- •Individuals with a history of any medical or dental conditions that could interfere with the success of dental restorations.
结局指标
主要结局
1. Effects of Er
时间窗: Regular follow-ups at 3 months, 6 months, 1 year, and 2 years
laser on cariogenic microorganisms and microbial load
时间窗: Regular follow-ups at 3 months, 6 months, 1 year, and 2 years
Primary Outcome: Reduction in cariogenic microorganisms (e.g., Streptococcus mutans counts, overall microbial load within the cavity).
时间窗: Regular follow-ups at 3 months, 6 months, 1 year, and 2 years
2. Comparison of patient experiences and assessments between Er
时间窗: Regular follow-ups at 3 months, 6 months, 1 year, and 2 years
laser and rotary bur
时间窗: Regular follow-ups at 3 months, 6 months, 1 year, and 2 years
Primary Outcome: Patient comfort (measured via Visual Analog Scale (VAS) for pain), procedure acceptability, and time required for caries excavation.
时间窗: Regular follow-ups at 3 months, 6 months, 1 year, and 2 years
3. Longevity and clinical outcomes of restorations
时间窗: Regular follow-ups at 3 months, 6 months, 1 year, and 2 years
Primary Outcome: Restoration success rate (no secondary caries, integrity of the restoration).
时间窗: Regular follow-ups at 3 months, 6 months, 1 year, and 2 years
4. Outcome for successful direct pulp capping using Er
时间窗: Regular follow-ups at 3 months, 6 months, 1 year, and 2 years
laser vs. conventional methods
时间窗: Regular follow-ups at 3 months, 6 months, 1 year, and 2 years
Primary Outcome: Pulp vitality and successful healing (assessed via clinical and radiographic signs of pulp health).
时间窗: Regular follow-ups at 3 months, 6 months, 1 year, and 2 years
5. Effects of photobiomodulation with diode laser in conjunction with Er
时间窗: Regular follow-ups at 3 months, 6 months, 1 year, and 2 years
laser therapy
时间窗: Regular follow-ups at 3 months, 6 months, 1 year, and 2 years
次要结局
- The secondary outcomes include cavity cleanliness, patient comfort (anesthesia needs, anxiety), and postoperative sensitivity, alongside clinical metrics like secondary caries, restoration integrity, and pulpal healing. Additional focus is given to patient satisfaction and healing when photobiomodulation is used with Er(laser therapy. These outcomes offer a broader perspective on treatment efficacy and patient experience.)
研究者
Dr Sourabh T J
government dental college and research institute