NCT05406557

Brief Summary

This study will compare the outcome of partial and miniature pulpotomy in mature permanent molars with symptomatic partial 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
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 6, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

May 29, 2022

Last Update Submit

June 2, 2022

Conditions

Pulpitis - Irreversible

Keywords

Irreversible pulpitisPartial pulpotomyMiniature pulpotomyVital pulp therapy

Outcome Measures

Primary Outcomes (1)

  • Clinical and radiographic success

    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 (2)

  • Pain analysis

    Baseline to 7 days

  • Pulp sensibility testing

    Baseline to 12 months

Study Arms (2)

Partial pulpotomy

ACTIVE COMPARATOR

Removal of superficial 2-3 mm of pulp tissue from entire pulp chamber

Procedure: Partial pulpotomy

Miniature pulpotomy

ACTIVE COMPARATOR

Removal of superficial 2-3 mm of pulp tissue from only affected pulp horn

Procedure: Miniature pulpotomy

Interventions

Partial pulpotomyPROCEDURE

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.

Partial pulpotomy
Miniature pulpotomyPROCEDURE

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

Miniature pulpotomy

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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)

Dr. Ankita Ramani

Rohtak, Haryana, 124001, India

RECRUITING

Related Publications (1)

  • Ramani A, Sangwan P, Duhan J, Popat S, Sangwan A. Effect of lateral extent of pulp tissue removal on the outcome of partial pulpotomy for managing cariously exposed mature permanent molars with symptomatic irreversible pulpitis: A randomized clinical trial. Int Endod J. 2025 Jan;58(1):71-83. doi: 10.1111/iej.14152. Epub 2024 Oct 1.

    PMID: 39352296DERIVED

Study Officials

  • DR. ANKITA RAMANI, MDS

    PGIDS, ROHTAK, HARYANA, INDIA-124001

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DR. ANKITA RAMANI, MDS

CONTACT

+919582841539ramaniankita95@gmail.com

DR. PANKAJ SANGWAN, MDS

CONTACT

9996112202drps_1@yahoo.com

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 29, 2022

First Posted

June 6, 2022

Study Start

May 12, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

June 6, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)