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Comparing Laser and Conventional Pulpotomy Treatments in Patients with Tooth Pain

Comparative Evaluation of Healing Outcomes of LASER and Conventional Pulpotomy in Patients with Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087133
Enrollment
40
Registered
2025-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Laser Pulpotomy: The device used will be a diode laser, Epic X, with a wavelength of 940nm. The procedure will be performed under local anesthesia and rubber dam isolation. The laser en

Sponsors

Dr Divya Naik
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants who accept the study goals and requirements and are willing to participate in the study All Participants are in good health, based on their written health histories and oral interviews Participants range in age from 18 to 50 yrs old with both male and female Participants Participants with moderate to severe pain involving one tooth All vital teeth with irreversible pulpitis whether associated with or without apical periodontitis Participant with PAI index score of 1 Thermal and electric pulp tests yielded a positive result Only teeth with favorable conditions for rubber dam application are considered Teeth with fully developed apex Teeth with healthy periodontium with periodontal probing depth less than 3mm Permanent human teeth Intact teeth with no cracks or defects

Exclusion criteria

Exclusion criteria: Participants who will not accept the study freely Participants who do not provide authorization for participation Participants below 18 years and above 50 years of age Participants who have taken antibiotics in past 1 month Participants who have taken analgesic within past 48 hours Pregnant women and nursing mothers Participants with non-vital teeth Participants with acute or chronic dentoalveolar abscess or cellulitis Participants whose tooth has been accessed previously or endodontically treated Participants with inflamed pulp in which bleeding could not be controlled within 10 minutes Participants who have taken medications which in the opinion of the investigator could interfere with the conduct of the study eg corticosteroids antibiotics and analgesics in the past month Participants with known systemic disorders or immunocompromised conditions eg diabetes AIDS Participants who have a current or recent history of alcohol or other substance abuse Participants with PAI index score Participants with an intraoral and extraoral sinus tract Teeth with aggressive periodontitis and grade III mobility periodontal probing depth greater than 3mm Severe labially or lingually malposition teeth in which clinical access will be difficult

Design outcomes

Primary

MeasureTime frame
Evaluate the healing outcomes of laser pulpotomy compared with conventional pulpotomy in the management of patients with symptomatic irreversible pulpitis. Timepoint: 1 year follow up

Secondary

MeasureTime frame
outcome of radiographic success will be classified using a Orstavik s Periapical Index score (PAI). teeth with normal contour or width of PDL will be deliberated as success, and teeth with periapical radiolucency will be reported as failure. Timepoint: 1 year followup;the preoperative and post-operative pain levels will be recorded by using a visual analogue scale (VAS). Timepoint: The post operative pain levels will be recorded at intervals of 6 hours, 24 hours, and 7 days after the initial visit.

Countries

India

Contacts

Public ContactDr Divya Naik

MGM Dental College and Hospital Kamothe Navi Mumbai

drdolly02@gmail.com9967826262

Outcome results

None listed

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