Comparing Laser and Conventional Pulpotomy Treatments in Patients with Tooth Pain

Phase 3

Not yet recruiting

Conditions: Pulpitis,

Registration Number: CTRI/2025/05/087133

Lead Sponsor: Dr Divya Naik

Brief Summary: This randomized controlled trial investigates the comparativehealing outcomes of diode laser pulpotomy versus conventional pulpotomy inmature permanent teeth diagnosed with symptomatic irreversible pulpitis. As avital pulp therapy (VPT) technique, pulpotomy has gained traction as aminimally invasive alternative to root canal therapy (RCT), aiming to preservepulpal vitality while reducing procedural complexity, treatment costs, andpatient discomfort.

The diodelaser offers unique benefits, including precise tissue ablation, effectivehemostasis, and antibacterial properties, potentially minimizing bleeding,bacterial contamination, and mechanical damage during the procedure.Conventional pulpotomy, on the other hand, relies on well-establishedprotocols, including the use of sodium hypochlorite for hemostasis andmaterials like mineral trioxide aggregate (MTA) for pulp sealing and healing.

Keyobjectives of the study include assessing the clinical and radiographic successrates of both techniques, evaluating postoperative pain levels, and analyzinghealing dynamics over time. Additionally, the study examines whether diodelaser pulpotomy offers a more efficient and predictable approach to managingirreversible pulpitis or if conventional pulpotomy remains the standard ofcare.

The findingsaim to provide clarity on the optimal approach for treating symptomaticirreversible pulpitis in mature permanent teeth, potentially influencingclinical guidelines, improving patient outcomes, and expanding treatmentoptions beyond traditional root canal therapy.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the healing outcomes of laser pulpotomy compared with conventional pulpotomy in the management of patients with symptomatic irreversible pulpitis.	1 year follow up

Secondary Outcome Measures

Name	Time	Method
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.
the preoperative and post-operative pain levels will be recorded by using a visual analogue scale (VAS).

Trial Locations

Locations (1): MGM Dental College and Hospital
🇮🇳
Raigarh, MAHARASHTRA, India
MGM Dental College and Hospital
🇮🇳Raigarh, MAHARASHTRA, India
Dr Divya Naik
Principal investigator
9967826262
drdolly02@gmail.com