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Outcome of root canal therapy and pulpotomy on permanent mature molars

Comparison of the outcome of pulpotomy on permanent mature molars with carious pulp exposure with conventional root canal therapy: A comparative randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151226025695N3
Enrollment
900
Registered
2019-02-06
Start date
2017-03-05
Completion date
Unknown
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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. Diseases of pulp and periapical tissues Pulpitis Necrosis of pulp Pulp degeneration Acute apical periodontitis of pulpal origin Chronic apical per

Interventions

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.

Sponsors

Vice Chancellor for Research, Ministry of Health and Medical Education, Islamic Republic of Iran
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Haeri

Department of Endoodntics, Shahid Beheshti Dental School

Haeri.a@yahoo.com+98 21 2241 3897

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026