Clinical trial NCT04397315: Comparative Evaluation of Partial and Complete Pulpotomy in Permanent Molars
Official title: Comparative Evaluation of Partial and Complete Pulpotomy in Mature Permanent Molars With Clinical Signs Indicative of Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulpitis - Irreversible
Keywords: Irreversible Pulpitis
Complete Pulpotomy
Partial Pulpotomy
Vital Pulp Therapy
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the outcome of partial pulpotomy and complete pulpotomy in mature permanent molars with clinical signs indicative of irreversible pulpitis

Detailed description: After thorough history and clinical and radio graphic examination, and confirmation of eligibility for the study, written informed consent will be taken after explaining the procedure and its associated risks and benefits. Clinical diagnosis of irreversible pulpitis will be established based on a history of spontaneous pain or pain exacerbated by cold stimuli and lasting for a few seconds to several hours (lingering pain) compared to control teeth and which is reproducible using cold testing. Once included, study subjects will be randomly allocated to either Complete Pulpotomy group or Partial Pulpotomy group. (Mineral Trioxide Aggregate) MTA will be used as pulpotomy agent. A layer of resin modified Glass Ionomer liner will be placed over the MTA and tooth will be permanently restored with composite resin in second appointment.

Pain analysis will be carried out preoperatively and postoperatively at every 24 hours till 7 days after intervention. All the subjects will be followed up for evaluation of success at every 3 months from baseline to 1 year.

Eligibility criteria: Inclusion Criteria: Inclusion criteria

* The patient should be ≥18 years of age.
* Restorable molar teeth.
* Tooth should give positive response to pulp sensibility testing.
* Clinical diagnosis of irreversible pulpitis.
* Tooth with probing pocket depth and mobility are within normal limits.
* No signs of pulpal necrosis including sinus tract or swelling.
* Non-contributory medical history

Exclusion Criteria:

* Teeth with immature roots.
* No pulp exposure after caries excavation.
* Bleeding could not be controlled in 6 minutes.
* Insufficient bleeding after pulp exposure, the pulp is judged necrotic or partially necrotic.

Primary outcomes:
measure: Clinical Success and radiographic success
timeFrame: Baseline to 12 Months
Secondary outcomes:
measure: Pain analysis
timeFrame: Baseline to 7 days
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Ankita Ramani
state: Haryana
Study officials:
affiliation: POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
name: ANKITA RAMANI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramani A, Sangwan P, Tewari S, Duhan J, Mittal S, Kumar V. Comparative evaluation of complete and partial pulpotomy in mature permanent teeth with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2022 May;55(5):430-440. doi: 10.1111/iej.13714. Epub 2022 Mar 10.