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Comparative Evaluation of Partial and Complete Pulpotomy in Permanent Molars

Comparative Evaluation of Partial and Complete Pulpotomy in Mature Permanent Molars With Clinical Signs Indicative of Irreversible Pulpitis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04397315
Enrollment
74
Registered
2020-05-21
Start date
2019-01-01
Completion date
2020-06-30
Last updated
2020-05-27

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

Conditions

Pulpitis - Irreversible

Keywords

Irreversible Pulpitis, Complete Pulpotomy, Partial Pulpotomy, Vital Pulp Therapy

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.

Interventions

PROCEDUREPulpotomy to the level of canal orifices

Pulp tissue will be removed till the level of canal orifices.

PROCEDUREPulpotomy up to superficial 2-3 mm of pulp chamber

Only superficial pulp from the chamber will be removed

Sponsors

Postgraduate Institute of Dental Sciences Rohtak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical Success and radiographic successBaseline to 12 MonthsCLINICAL SUCCESS CRITERIA: Absence of spontaneous pain, discomfort, swelling, sinus tract or tenderness to palpation or percussion. RADIOGRAPHIC SUCCESS CRITERIA: No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic et al. Evaluation of both clinical and radiographic outcome is must for analyzing the actual success of therapeutic technique. Number of participants fulfilling both clinical as well as radiographic success criteria will be considered in success category.

Secondary

MeasureTime frameDescription
Pain analysisBaseline to 7 daysTo assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 10 Centimetere line. Score 0 means no pain and Score 10 means maximum pain.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026