Effects of root canal treatment with or without manual-dynamic irrigation on post-operative pain and periapical healing
- Conditions
- Apical periodontitisOral Health
- Registration Number
- ISRCTN67306656
- Lead Sponsor
- niversity College London/UCLH NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
Those patients on the waiting list for non-surgical root canal treatment or root canal retreatment in the Department of Endodontics, Eastman Dental Hospital, London, UK and fulfilling the following inclusion criteria (based on the notes from the New Patient Consultation Clinic and findings from the pre-treatment assessment session) will be invited to participate.
1. Age 18 years or older
2. Absence of history of diabetes and/or a medical condition which requires long-term steroid or anti-inflammatory/analgesic medication
3. Absence of history of chronic orofacial pain, major traumatic injuries, or major maxillo-facial surgery
4. Absence of persistent or spontaneous pre-operative pain at New Patient Clinic
5. Able to attend two consecutive appointments for treatment to be completed within 1 month
6. The teeth should be permanent with mature apex (apices)
7. The teeth should have a non-vital pulp (negative response to pulp testing) and associated with a periapical radiolucency observable on a periapical radiograph
8. In cases of teeth requiring root canal retreatment, the predicted treatment complexity should be low based on radiographic examination. The features include:
8.1. Less than 15º canal curvature
8.2. The root canal system anatomy minimally altered by previous treatment
8.3. Only gutta-percha filling present in the root canal
8.4. Low density of previous root filling
8.5. Root filling material confined within the root canal limits
8.6. Absence of procedural errors
8.7. Previous apical surgery not evident
9. Teeth should have been deemed restorable without the need for intra-radicular retention for the final restoration, and have sufficient tooth structure to allow an adequate form of temporization (capable of providing a barrier against leakage during treatment and/or between appointments)
10. The teeth should not be associated with active periodontal disease
11. The teeth and root apices should not be in proximity (less than 1 mm on a periapical radiograph) to the maxillary sinus, inferior dental nerve or the mental foramen
1. Pregnant patients
2. Patients without a good understanding of the verbal explanations or written information given in English, as well as patients with special communication needs (in view of the descriptive nature of this self-funded Master student research project, there is insufficient funding to support the cost for translation services and validation of consent form information sheets, questionnaires)
3. Teeth with observable cracks or suspicion of root fracture
4. Teeth in which mechanical patency could not be achieved at the apical terminus of at least one canal
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The pain experienced at 12-24, 24-48, 48-72 hours after each root canal treatment visit will be measured using a Visual Analogue Scale score (0 = no pain; 10 = worst patient imaginable)
- Secondary Outcome Measures
Name Time Method Periapical healing at 12 months after completion of the root canal treatment will be judged to be successful if there is absence of clinical (pain, swelling, presence of a 'gum boil') or radiographic (dark area around the root) signs of disease at follow-up