]>
IRCT20151226025695N3 IRCT 2019-02-06 Vice Chancellor for Research, Ministry of Health and Medical Education, Islamic Republic of Iran Outcome of root canal therapy and pulpotomy on permanent mature molars Root canal therapy and pulpotomy Comparison of the outcome of pulpotomy on permanent mature molars with carious pulp exposure with conventional root canal therapy: A comparative randomized clinical trial 2017-03-05 anticipated 900 Complete https://irct.ir/trial/21441 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a software has been designed to randomize the treatment group of participating patients. For each practitioner, eligible patients will be randomized into three study arms, using a computer-generated system; Randomization performed online via www.mcrct.ir website right after the recording of patient's demographic data and before the starting of treatment (allocation concealment). Patients stratified with 1:1:1 allocation in the three study arms. 3 Condition 1: Diseases of pulp and periapical tissues. Condition 2: Inflammation of the pulp. Condition 3: Necrosis of pulp. Condition 4: Pulp degeneration. Condition 5: Acute apical periodontitis of pulpal origin. Condition 6: Chronic apical periodontitis. Condition 7: Periapical abscess with sinus. Condition 8: Periapical abscess without sinus. Intervention 1: Intervention group 1: Pulpotomy with CEM Cement. Intervention 2: Intervention group 2: Pulpotomy with ProRoot MTA. Intervention 3: Control group: Root canal therapy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Ali Haeri
Shahid Beheshti Dental School, Daneshjoo Boulevard, Evin
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2241 3897 Haeri.a@yahoo.com Department of Endoodntics, Shahid Beheshti Dental School scientific Mohammad Jafar Eghbal
Shahid Beheshti Dental School, Danshjoo Boulevard, Evin
Tehran Iran (Islamic Republic of) 1983963113 00219822413897 mje782002@yahoo.com Department of Endodontics, Shahid Beheshti Dental School Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) A vital molar tooth (confirmed with cold spray and electric pulp tester before treatment and visual inspection of pulpal hemorrhage after access cavity preparation) A history of pain indicating irreversible pulpitis (i.e. spontaneous localized/generalized pain, pain stimulated by hot and cold fluids that lasts after elimination of the stimulus and is reproducible with cold testing) Pulp exposure during caries removal when no sign of irreversible pulpitis is present Patients in the range of 12 to 65 years Patients who accept to attend for recalls Patients who approve and sign the written informed consent 12 years 65 years Both Patients with systemic conditions that disturbe tissue healing process (including diabetes, cancer, endocrine diseases, AIDS and consumption of corticosteroids) Patients with epinephrine intolerance Pregnant/nursing women Physically disabled or mentally retarded patients Patients with poor oral hygiene or those with periodontal diseases, where the long term preservation of the tooth may not be possible Immigrants such as those from Afghanistan, who are likely to leave the country during the subsequent two years Patients younger than 12 (for 1st molar treatment) and 17 (for 2nd molar treatment) and patients older than 65; Non-vital/partially necrotic teeth confirmed with primary examinations or diagnosed after access cavity preparation Teeth with pulpal inflammation spreading beyond the canal orifices, and continuous bleeding after placement of cotton pellet soaked in 2.5% sodium hypochlorite for a maximum of 10 minutes Teeth that are not appropriate candidates for class I and II (Occlusal, MO, DO, MOD) restoration and require complicated build-ups, crown lengthening or prosthetic crown Teeth with localized periodontal disease (i.e. probing depth more than 3 mm) where the tooth survival is not endangered but pulpal irritation and disturbed healing due to root exposure is likely Internal/external root resorption or pulp calcification detectable in periapical radiography Teeth with history of trauma Swelling of surrounding soft tissues Teeth with immature apices Presence of sinus tract K04 K04.0 K04.1 K04.2 K04.4 K04.5 K04.6 K04.7 Diseases of pulp and periapical tissues Pulpitis Necrosis of pulp Pulp degeneration Acute apical periodontitis of pulpal origin Chronic apical periodontitis Periapical abscess with sinus Periapical abscess without sinus Prevention Prevention Prevention Intervention group 1: Pulpotomy with CEM Cement Intervention group 2: Pulpotomy with ProRoot MTA Control group: Root canal therapy Sign and symptoms of pulpal inflammation/infection (spontaneous unstimulated pain). Timepoint: One week and 6, 12 and 24 months after intervention. Method of measurement: Clinical examination and VAS (visual analogue scale) questionnaire. Sign and symptoms of pulpal inflammation (internal/external resorption). Timepoint: One week and 6, 12 and 24 months after intervention. Method of measurement: Periapical radiographs. Sign and symptoms of periapical inflammation (pain on percussion and palpation). Timepoint: One week and 6, 12 and 24 months after intervention. Method of measurement: Clinical examination and VAS (visual analogue scale) questionnaire. Sign and symptoms of periapical infection (pain, redness, swelling or formation of sinus tract). Timepoint: One week and 6, 12 and 24 months after intervention. Method of measurement: Clinical examination and VAS (visual analogue scale) questionnaire. Vice Chancellor for Research, Ministry of Health and Medical Education, Islamic Republic of Iran Approved 2017-01-12 Ethics Committee, Research Institute of Dental Sciences, Iranian Center for Endodontic Research, Sha Research Institute of Dental Sciences, Shahid Beheshti Dental School, Evin Tehran Tehran Iran (Islamic Republic of)