Effect of modified Photo Biomodulation protocols on post operative endodontic pain following single visit endodontics in patients with symptomatic irreversible pulpitis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pre and post operative pain score on non graded VAS scale between 0 to 10
研究概览
简要总结
60 patients requiring endodontic treatments in vital mandibular molar teeth with symptomatic irreversible pulpitis are selected . The patients’ demographic data including age, gender and tooth number are recorded. Patients are provided with a non-numeral 10cm VAS to record their tooth pain. Their preoperative pain values are recorded. A single visit endodontic treatment is advised. The root canal procedures are performed by following a standardized protocol. A final radiograph is taken to confirm the quality of the root filling. Then the patients are randomly allocated for real or sham laser irradiation. Low level laser is irradiated to the buccal mucosa overlying the apices of the target tooth in the study groups. In the sham group patients received placebo laser to eliminate the probable psychological effects of laser. After laser/sham treatment, each patient is given a home questionnaire and a second appointment is scheduled for permanent tooth restoration one week later. Each patient is given 10 tablets of 500 mg acetaminophen and are instructed to take them in case of pain. The patients are instructed to record their postoperative pain levels at 4, 8, 12 ,24 and 48h after treatment on separate VAS scales. The patients are contacted by phone on specific hours to remind them to record their pain level. They are also asked to record consumption of analgesic on the questionnaire (dosage and exact time of taking the analgesic).Patients are free to ask for an unscheduled appointment, if needed, which will also be recorded. At the second visit scheduled 1 week later, the patients are asked to return the questionnaires, and their chair side level of pain on palpation and percussion are also recorded on VAS scale.
GROUP 1 :Laser irradiation is done with 940 nm laser post treatment with a dosage of 8J energy.
GROUP 2 :Laser irradiation is done with 810nm laser post treatment with a dosage of 8J energy.
GROUP 3 :Laser irradiation is done with 940nm laser pre & post treatment with a dosage of 4J energy each.
GROUP 4 : Laser irradiation is done with 810nm laser pre & post treatment with a dosage of 4J energy each.
GROUP 5: is the sham group where laser is placed but not activated
**EXPECTED OUTCOME-**There will be a difference in reduction of post operative endodontic pain intensity following irradiation using 940nm and 810nm lasers and their modified protocols
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients scheduled for root canal treatment for symptomatic irreversible pulpitis on first or second mandibular molars are included Patients scheduled for root canal treatment for symptomatic irreversible pulpitis on first or second mandibular molars are included.
排除标准
- •Patients are not included into the study if one of the following criteria applied: severe general disease (ASA classes 3 and 4), pregnancy, known allergies to local anaesthetics , and NSAIDs, acute apical periodontitis , recent history of chronic pain medication Patients are excluded in case of periodontal probing greater than 3 mm, swelling or sinus tract and tenderness on palpation.
结局指标
主要结局
pre and post operative pain score on non graded VAS scale between 0 to 10
时间窗: 4h,8h,12h,24h and 48h after treatment
次要结局
- post operative pain score on non graded VAS scale between 0 to 10(7 days after treatment)
研究者
Dr KEERTHY P K
Malabar dental college and research centre, Edappal,Malappuram, Kerala