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IRCT20220305054200N1 IRCT 2022-04-25 Zahedan University of Medical Sciences Outcome of root canal therapy and pulpotomy on permanent mature molars Root canal therapy and pulpotomy Evaluation of full pulpotomy in cariously exposed mature permanent molar teeth with new calcium silicate cement : A Randomized Clinical Trial 2022-04-24 anticipated 90 Complete https://irct.ir/trial/62342 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 right after the recording of patient's demographic data and before the starting of treatment. Patients stratified with 1:1:1 allocation in the three study arms. N/A Condition 1: Diseases of pulp and periapical tissues. Condition 2: Pulpitis. Intervention 1: Control group: Root canal therapy. Intervention 2: Intervention group 1: Pulpotomy with new calcium silicate cement. Intervention 3: Intervention group 2: Pulpotomy with MTA. 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 Farnaz Faramarzian
Dental Faculty Of Zahedan, Azadegan Sharghi Ave.
Zahedan Iran (Islamic Republic of) 9817699693 +98 54 3344 1814 farnazfaramarzian@gmail.com Zahedan University of Medical Sciences scientific Farnaz Faramarzian
Dental Faculty Of Zahedan, Azadegan Sharghi Ave.
Zahedan Iran (Islamic Republic of) 9817699693 +98 54 3344 1814 farnazfaramarzian@gmail.com Zahedan University of Medical Sciences 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 50 years Patients who accept to attend for recalls Patients who approve and sign the written informed consent 12 years 50 years Both Patients with systemic conditions that disturb 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 15 (for 2nd molar treatment) and patients older than 50 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 Diseases of pulp and periapical tissues Pulpitis Prevention Prevention Prevention Control group: Root canal therapy Intervention group 1: Pulpotomy with new calcium silicate cement Intervention group 2: Pulpotomy with MTA Sign and symptoms of pulpal inflammation/infection (spontaneous unstimulated pain). Timepoint: Six months after treatmentOne week and 6 months after intervention. Method of measurement: Clinical examination and VAS (visual analogue scale) questionnaire. Sign and symptoms of pulpal inflammation (internal/external resorption). Timepoint: Six months after treatmentOne week and 6 months after intervention. Method of measurement: Periapical radiographs. Sign and symptoms of periapical inflammation (pain on percussion and palpation). Timepoint: Six months after treatmentOne week and 6 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: Six months after treatmentOne week and 6 months after intervention. Method of measurement: Clinical examination and VAS (visual analogue scale) questionnaire. Zahedan University of Medical Sciences Approved 2022-02-26 Ethics committee of Zahedan University of Medical Sciences Dental Faculty Of Zahedan, Azadegan Sharghi Ave. Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)