Evaluation of Effect of Hemostasis Time on Partial Pulpotomy in Mature Permanent Teeth With Clinical Signs Indicative of Irreversible Pulpitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- 1.Clinical success rate
研究概览
简要总结
The aim of this prospective study is to investigate the influence of time taken to achieve hemostasis on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
OBJECTIVE:-
- To evaluate clinical and radiographic success of time taken to achieve hemostasis on outcome of partial pulpotomy in mature permanent teeth with clinical signs indicative of irreversible pulpitis.
- To evaluate OHRQoL and pain incidence & severity after partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
Participants will of age group 18 to 45 years will be included and divided into two groups based on hemostasis time:
I(Intervention) - 6minutes C (Comparison) - 7-12 minutes
详细描述
TITLE:- Evaluation of hemostasis time on partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.
P (Population) - Mature permanent molars with clinical signs of irreversible pulpitis.
I (Intervention) - 6minutes C (Comparison) - 7-12 minutes O (Outcome) - Assessment of clinical and radiographic success at 12 months of follow up .
Assessment of OHRQoL at baseline, post-operatively every 24 hours for 1 week & incidence and severity of pain at baseline and post-operatively every 24 hours till 1 week.
Time taken to achieve hemostasis has been suggested as a reliable surrogate measure to determine the depth of inflammation in the pulp. In absence of any other intraoperative indicator, it serves as a useful guide to the extent of pulp tissue removal required during pulpotomy. This trial will help formulate evidence based guideline regarding time for hemostasis advisable to achieve optimum success during pulpotomy in teeth with signs indicative of irreversible pulpitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mature permanent mandibular molars with carious pulp exposures and signs suggestive of irreversible pulpitis.
- •vital pulp with demonstrable bleeding upon entry.
- •The tooth is restorable.
- •Tooth with mobility and probing depth within normal limits.
- •Soft tissues around the tooth are normal with no swelling or sinus tract.
- •No evidence of chronic apical periodontitis (PAI 1,2)
排除标准
- •patients who report history of antibiotic intake in past 1 month or analgesic intake in past 3 days.
- •pregnant women.
- •absence of opposing teeth
- •3rd molars
- •medically compromised patients .
- •Tenderness on percussion positive
- •pathologic mobility
研究组 & 干预措施
Hemostasis time upto 6 minutes
after partial pulpotomy, procedure pulp wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 minutes and will be repeated if required and time taken to achieve hemostasis will be recorded using stop watch.
干预措施: effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. (Procedure)
hemostasis time 7 to 12 minutes
after partial pulpotomy, procedure pulp wound will be irrigated with 3% NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3% NaOCl over the pulpal wound for 2 minutes and will be repeated if required and time taken to achieve hemostasis will be recorded using stop watch.Root canal therapy will be initiated in cases in which haemostasis is not achieved even after 12 minutes.
干预措施: effect of hemostasis time on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis. (Procedure)
结局指标
主要结局
1.Clinical success rate
时间窗: baseline to 12 months
Clinical criteria of success:- 1. No pain or discomfort except for the first few days after treatment. 2. No tenderness to palpation or percussion and the tooth is functional. 3. Normal mobility and probing pocket depth. 4. Healthy soft tissues around teeth with no swelling, sinus tract.
2.Radiographic success rate
时间窗: baseline to 12 months
Radiographic success criteria:- 1. No pathosis such as root resorption, furcal pathosis or new periapical pathosis evident on the radiograph. 2. Complete radiographic healing
次要结局
- Post Operative Pain(Baseline to 7 days])
- OHRQoL assessment(baseline and at 24 hours, day 2, day 3, day4, day 5, day 6 and day 7 after the treatment.)