CTRI/2025/07/089989
Not yet recruiting
Phase 3
Clinical and radiographic outcomes of full and partial pulpotomy using Biodentine in the management of carious mature permanent molars diagnosed with symptomatic irreversible pulpitis: A Randomized Controlled Trail
Dr Chahat1 site in 1 country30 target enrollmentStarted: July 15, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Dr Chahat
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Outcome will be assessed on Clinical Evaluation and Radiographic Assesment.
Overview
Brief Summary
This study evaluates the effectiveness of full and partial pulpotomy using Biodentine in treating decayed mature permanent molars diagnosed with symptomatic irreversible pulpitis. Both clinical and radiographic outcomes were assessed to determine which technique better preserves tooth vitality and promotes healing. The results suggest that both approaches can be successful alternatives to root canal treatment, offering effective pain relief and maintaining the health of the remaining pulp tissue.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Mature first and second (upper and lower) molar tooth.
- •Patients with clinical presentation of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (interpreted as lingering pain) and which could be reproduced using cold testing or EPT.
- •Positive response to cold testing with no signs of pulpal necrosis including swelling or sinus tract.
- •The tooth is restorable with no need for a crown or post retained restoration.
- •Normal probing pocket depth and tooth mobility.
- •Patients with radiographic evidence of caries involving the entire thickness of dentine.
- •Normal periapical structures.
Exclusion Criteria
- •Immature molars with open apex.
- •Radiolucency at the periapical zones or furcation.
- •Existence of calcification (pulp stone, diffuse calcification, disk-like chamber) and internal or external resorption.
- •Existence of swelling of the sinus tract and the negative response to testing.
- •Uncontrolled bleeding after pulpotomy lasting for more than 10 minutes.
- •Bleeding is not sufficient after pulp exposure, the pulp is judged partially necrotic.
- •Non restorable teeth.
Outcomes
Primary Outcomes
Outcome will be assessed on Clinical Evaluation and Radiographic Assesment.
Time Frame: At 1 week, 3 months and 6 months
Secondary Outcomes
- Outcome will be assessed on Radiographic Assessment.(3 months)
Investigators
Dr Chahat
Deaprtment of Conservative Dentistry and Endodontics, Himachal Dental College and Hospital
Study Sites (1)
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