NCT04397315

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1.5 years

First QC Date

May 12, 2020

Last Update Submit

May 23, 2020

Conditions

Pulpitis - Irreversible

Keywords

Irreversible PulpitisComplete PulpotomyPartial PulpotomyVital Pulp Therapy

Outcome Measures

Primary Outcomes (1)

  • Clinical Success and radiographic success

    CLINICAL 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.

    Baseline to 12 Months

Secondary Outcomes (1)

  • Pain analysis

    Baseline to 7 days

Study Arms (2)

Complete Pulpotomy

ACTIVE COMPARATOR

In case of complete pulpotomy procedure the exposed pulp tissue will be amputated using sterile bur in high speed hand piece to the level of canal orifices.

Procedure: Pulpotomy to the level of canal orifices

Partial Pulpotomy

ACTIVE COMPARATOR

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

Procedure: Pulpotomy up to superficial 2-3 mm of pulp chamber

Interventions

Pulpotomy to the level of canal orificesPROCEDURE

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

Complete Pulpotomy
Pulpotomy up to superficial 2-3 mm of pulp chamberPROCEDURE

Only superficial pulp from the chamber will be removed

Partial Pulpotomy

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankita Ramani

Rohtak, Haryana, 124001, India

Location

Related Publications (2)

  • Ramani A, Sangwan P. Outcome Following Complete and Partial Pulpotomy in Managing Cariously Exposed Mature Permanent Molars With Symptomatic Irreversible Pulpitis: A 5-Year Follow-Up of a Randomised Clinical Trial. Int Endod J. 2025 Dec;58(12):1835-1848. doi: 10.1111/iej.70028. Epub 2025 Sep 2.

    PMID: 40898413DERIVED

  • 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.

    PMID: 35226769DERIVED

Study Officials

  • ANKITA RAMANI

    POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 21, 2020

Study Start

January 1, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

May 27, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)