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Partial Versus Miniature Pulpotomy in Teeth With Irreversible Pulpitis

Primary Purpose

Pulpitis - Irreversible

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Partial pulpotomy
Miniature pulpotomy
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, Partial pulpotomy, Miniature pulpotomy, Vital pulp therapy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dr. Ankita RamaniRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Partial pulpotomy

Miniature pulpotomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain
Pulp sensibility testing
To assess pulp tissue response using cold and electric pulp test at 6 and 12 months

Full Information

First Posted
May 29, 2022
Last Updated
June 2, 2022
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT05406557
Brief Title
Partial Versus Miniature Pulpotomy in Teeth With Irreversible Pulpitis
Official Title
Outcome Comparing Partial and Miniature Pulpotomy in Mature Permanent Molars With Symptomatic Partial Irreversible Pulpitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible
Keywords
Irreversible pulpitis, Partial pulpotomy, Miniature 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
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Partial pulpotomy
Arm Type
Active Comparator
Arm Description
Removal of superficial 2-3 mm of pulp tissue from entire pulp chamber
Arm Title
Miniature pulpotomy
Arm Type
Active Comparator
Arm Description
Removal of superficial 2-3 mm of pulp tissue from only affected pulp horn
Intervention Type
Procedure
Intervention Name(s)
Partial pulpotomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Miniature pulpotomy
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical and radiographic success
Description
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 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain
Time Frame
Baseline to 7 days
Title
Pulp sensibility testing
Description
To assess pulp tissue response using cold and electric pulp test at 6 and 12 months
Time Frame
Baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DR. ANKITA RAMANI, MDS
Phone
+919582841539
Email
ramaniankita95@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
DR. PANKAJ SANGWAN, MDS
Phone
9996112202
Email
drps_1@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DR. ANKITA RAMANI, MDS
Organizational Affiliation
PGIDS, ROHTAK, HARYANA, INDIA-124001
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Ankita Ramani
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DR. ANKITA RAMANI, MDS
Phone
09582841539
Email
ramaniankita95@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Partial Versus Miniature Pulpotomy in Teeth With Irreversible Pulpitis

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