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Comparative Evaluation of Partial and Complete Pulpotomy in Permanent Molars

Primary Purpose

Pulpitis - Irreversible

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Pulpotomy to the level of canal orifices
Pulpotomy up to superficial 2-3 mm of pulp chamber
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis - Irreversible focused on measuring Irreversible Pulpitis, Complete Pulpotomy, Partial Pulpotomy, Vital Pulp Therapy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ankita Ramani

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Complete Pulpotomy

Partial Pulpotomy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain analysis
To 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.

Full Information

First Posted
May 12, 2020
Last Updated
May 23, 2020
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT04397315
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible
Keywords
Irreversible Pulpitis, Complete Pulpotomy, Partial Pulpotomy, Vital Pulp Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Complete Pulpotomy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Partial Pulpotomy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pulpotomy to the level of canal orifices
Intervention Description
Pulp tissue will be removed till the level of canal orifices.
Intervention Type
Procedure
Intervention Name(s)
Pulpotomy up to superficial 2-3 mm of pulp chamber
Intervention Description
Only superficial pulp from the chamber will be removed
Primary Outcome Measure Information:
Title
Clinical Success and radiographic success
Description
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.
Time Frame
Baseline to 12 Months
Secondary Outcome Measure Information:
Title
Pain analysis
Description
To 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.
Time Frame
Baseline to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANKITA RAMANI
Organizational Affiliation
POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankita Ramani
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35226769
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.
Results Reference
derived

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Comparative Evaluation of Partial and Complete Pulpotomy in Permanent Molars

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