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Partial Versus Miniature Pulpotomy in Teeth With Irreversible Pulpitis

Outcome Comparing Partial and Miniature Pulpotomy in Mature Permanent Molars With Symptomatic Partial Irreversible Pulpitis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05406557
Enrollment
86
Registered
2022-06-06
Start date
2022-05-12
Completion date
2023-07-31
Last updated
2022-06-06

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, Partial pulpotomy, Miniature pulpotomy, Vital pulp therapy

Brief summary

This study will compare the outcome of partial and miniature pulpotomy in mature permanent molars with symptomatic partial irreversible pulpitis

Detailed description

After thorough history and clinical and radiographic examination, and confirmation of eligibility for the study, written informed consent will be obtained from study participants after explaining the procedure and its associated risks and benefits. Clinical diagnosis of symptomatic partial 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 Miniature Pulpotomy group or Partial Pulpotomy group. MTA (Mineral Trioxide Aggregate) 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 same 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 clinical and radiographic success at 6 and 12 months from baseline.

Interventions

In case of partial pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece with water coolant to a depth of superficial 2-3 mm of pulp chamber.

PROCEDUREMiniature pulpotomy

In case of miniature pulpotomy procedure the exposed pulp tissue will be amputated using a sterile bur in the high speed hand piece with water coolant to a depth of superficial 2-3 mm of only affected pulp horn

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 45 Years
Healthy volunteers
Yes

Inclusion criteria

* The patient with18 -45 years of age. * Restorable molar teeth. * Tooth should give positive response to pulp sensibility testing. * Clinical diagnosis of symptomatic partial 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 and radiographic successBaseline to 12 MonthsAbsence 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 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain
Pulp sensibility testingBaseline to 12 monthsTo assess pulp tissue response using cold and electric pulp test at 6 and 12 months

Countries

India

Contacts

Primary ContactDR. ANKITA RAMANI, MDS
ramaniankita95@gmail.com+919582841539
Backup ContactDR. PANKAJ SANGWAN, MDS
drps_1@yahoo.com9996112202

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026