Effect Of Combination of Calcium Hydroxide And Chlorhexidine Gel 2% as Intracanal Medication in Comparison to Calcium Hydroxide Paste as Intracanal Medication on Postoperative Pain And Bacterial Endotoxins in Necrotic Teeth:
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 主要终点
- postoperative pain
研究概览
简要总结
The aim of this prospective in vivo randomized clinical trial to evaluate influence of combination of calcium Hydroxide (CALCIPAST Paste, Poland) and chlorhexidine Gel 2% (Gluco-Chex 2%, Cerkamed, Poland) in comparison to calcium hydroxide paste (CALCIPAST Paste, Poland) as Intracanal Medication on post operative pain (incidence, degree, duration) and reduction of bacterial endotoxins (quantitative) after endodontic treatment in single rooted necrotic teeth.
According to the inclusion criteria the patients enrolled in the study and allocated randomly into three groups either combination of calcium hydroxide paste intracanal medication with 2% chlorhexidine gel. (group A) or calcium hydroxide paste intracanal medication only (group B) or mechanical preparation without intracanal medications (group C) the endodontic treatment is done at two visits.
The samples of endotoxin divided into three groups: after access (S1), after mechanical instrumentations (S2), after removal intracanal medication (S3), all samples taken by a sterile paper points introduced in the root canal for the working length for 60 seconds.
firstly the patient's medical and dental history is taken. the patients assign on informed consent. and then anaesthetized and access cavity performed and root canal preparation is done by Revo-s system then irrigation and intracanal medication placement inside to canal. the patient's record the post operative pain in sheet with NRS after 4, 24, 48 hours and 2 weeks after first visit. the operator will recall the patient to check the records
second visit After 2 weeks from application of ICM, rubber dam will be applied then removal of the temporary dressing, then a sterile paper point (S3) will be introduced into the canals after irrigation and removal of the remnants of the intracanal medicament with the saline solution.
- Removal of the paper sample to determine the endotoxin concentration.
- The canals will be obturated by single cone technique using gutta percha point tapered 0.4% (Gutta percha point, Revo-S MicroMega CO., LTD, France) corresponding to the final apical size of the file and the root canal sealer will be resin sealer (Adseal, META BIOMED CO., LTD, Korea).
- Pain will be assessed by numerical pain rating scale (NRS) after 14 days from the first visit (at the day of the Obturation) before the beginning of Obturation.
详细描述
Medical and dental history: diagnostic charts will be collected in a case report from by the investigators and confirmed for eligibility with the assistant supervisor.
Radiographic examination: preoperative radiographs will be taken to examine the tooth structure, caries detection, periapical status.
Clinical examination: intraoral examination include visual examination for caries, restorations, swelling, fistula, mobility, percussion were done.
Diagnostic criteria for necrotic tooth:
- The patient marks moderate to severe pain on the numerical rating scale (NRS)a horizontal line of 11 marks and 10 intervals each takes number form 0 - 10 0 reading represents "no pain", 1- 3 readings represent "mild pain", 4- 6 readings represent "moderate pain", 7- 10 readings represent "severe pain".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in Good Health(American Society Of Anaesthesiology Class II or higher).
- •Adult patients from both genders older than 18-50 years old suffering from chronic periapical periodontitis with necrotic pulp.
- •single rooted teeth (maxillary and mandibular).
- •Patients who can understand numerical rating scale (NRS)
- •Patients able to sign informed consent
排除标准
- •Patients with Vital tooth.
- •Patients having active pain in more than one tooth.
- •Patients who had taken analgesics in 12 hours preceding the preparation.
- •Any type of teeth with multi roots.
- •Pulp hyperemia or any other conditions other than pulp necrosis like pulpitis or previously accessed teeth with temporary fillings and patients suffering from chronic disease (systemic diseases).
- •Pregnant or mentally retarded patients.
研究组 & 干预措施
Calcium Hydroxide Mixed With Chlorhexidin
efficacy of calcium hydroxide and 2 % chlorhexidine gel and combination of both on the anaerobic bacteria, It was clear from the study that calcium hydroxide had limited efficacy against facultative anaerobes, but effective against obligate anaerobes while chlorhexidine only and combination group were effective against all species of anaerobic bacteria.
干预措施: Chlorhexidine 2% gel - Calcium Hydroxide Paste - Non-Setting (Drug)
Calcium Hydroxide
The antimicrobial activity of calcium hydroxide Ca(OH)2 is related to the release of hydroxyl ions in an aqueous environment leading to damage in the bacterial cytoplasmic membrane, protein denaturation and DNA damage
干预措施: Calcium Hydroxide Paste - Non-Setting (Drug)
Placebo
Mechanical preparation without intracanal medications.
干预措施: Chlorhexidine 2% gel - Calcium Hydroxide Paste - Non-Setting (Drug)
Placebo
Mechanical preparation without intracanal medications.
干预措施: Calcium Hydroxide Paste - Non-Setting (Drug)
结局指标
主要结局
postoperative pain
时间窗: 4, 24, 48 hrs and 2 weeks after completion of treatment
intensity of postoperative pain between visits by numerical Rating Scale (0- 10)
次要结局
- bacterial endotoxins reductions(After access cavity, after mechanical preparation and after removal of intracanal medication (2 weeks after the first visit))
研究者
Mohammed Saadi Alarbeed
master candidate at endodontic department faculty of oral and dental medicine CU
Cairo University