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Outcome Following Endodontic Treatment Using Traditional Access Versus Conservative Access

Primary Purpose

Pulpitis - Irreversible

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Endodontic treatment using traditional access
Endodontic treatment using conservative access
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, Endodontic treatment, Traditional access, Conservative access, Contracted endodontic cavities

Eligibility Criteria

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

Inclusion Criteria:

  • The patient should be ≥18 years of age.
  • Restorable mandibular molars with extremely deep caries involving occlusal surface only
  • Clinical diagnosis of symptomatic irreversible pulpitis with PAI score ≤2.
  • Tooth should give positive response to pulp sensibility testing.
  • Tooth with probing pocket depth and mobility are within normal limits.
  • Non-contributory medical history.

Exclusion Criteria:

  • Teeth with immature roots.
  • No pulp exposure even after caries excavation.
  • Teeth with signs of pulpal necrosis including sinus tract or swelling.
  • Teeth with percussion sensitivity
  • Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis
  • Had taken analgesic in past 3 days
  • Teeth with pathologic changes such as internal or external resorption
  • Teeth with morphological variation
  • Teeth with root canal calcification
  • Teeth with fixed full coverage prosthesis

Sites / Locations

  • Dr. Ankita RamaniRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Endodontic treatment using traditional access

Endodontic treatment using conservative access

Arm Description

Straight line access will be achieved following complete removal of pulp chamber roof

Part of pulp chamber roof will be preserved and no efforts will be directed to achieve straight line access

Outcomes

Primary Outcome Measures

Clinical 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 100 Millimeter line. Score 0 means no pain and Score 100 means maximum pain.

Full Information

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

Unique Protocol Identification Number
NCT05402098
Brief Title
Outcome Following Endodontic Treatment Using Traditional Access Versus Conservative Access
Official Title
Comparative Evaluation of Outcome Following Endodontic Treatment Using Traditional Versus Conservative Access in Mandibular Molars With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
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
September 2023 (Anticipated)
Study Completion Date
September 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 endodontic treatment using conservative or traditional access design in 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 obtained after explaining the procedure and its associated risks and benefits. Clinical diagnosis of symptomatic 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 traditional access or conservative access group. Subsequently biomechanical preparation will be carried out using standard protocol with the use of rotary NiTi file system followed by root canal filling using gutta percha and zinc oxide eugenol sealer. Teeth will be restored using composite resin in the 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 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, Endodontic treatment, Traditional access, Conservative access, Contracted endodontic cavities

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Endodontic treatment using traditional access
Arm Type
Active Comparator
Arm Description
Straight line access will be achieved following complete removal of pulp chamber roof
Arm Title
Endodontic treatment using conservative access
Arm Type
Experimental
Arm Description
Part of pulp chamber roof will be preserved and no efforts will be directed to achieve straight line access
Intervention Type
Procedure
Intervention Name(s)
Endodontic treatment using traditional access
Intervention Description
Endodontic treatment will be carried out following complete removal of pulp chamber roof and achieving straight line access
Intervention Type
Procedure
Intervention Name(s)
Endodontic treatment using conservative access
Intervention Description
Endodontic treatment will be carried out following partial removal of pulp chamber roof, extended only to the extent which helps to locate all the orifices with no efforts will be made to achieve straight line access
Primary Outcome Measure Information:
Title
Clinical 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 100 Millimeter line. Score 0 means no pain and Score 100 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
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The patient should be ≥18 years of age. Restorable mandibular molars with extremely deep caries involving occlusal surface only Clinical diagnosis of symptomatic irreversible pulpitis with PAI score ≤2. Tooth should give positive response to pulp sensibility testing. Tooth with probing pocket depth and mobility are within normal limits. Non-contributory medical history. Exclusion Criteria: Teeth with immature roots. No pulp exposure even after caries excavation. Teeth with signs of pulpal necrosis including sinus tract or swelling. Teeth with percussion sensitivity Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis Had taken analgesic in past 3 days Teeth with pathologic changes such as internal or external resorption Teeth with morphological variation Teeth with root canal calcification Teeth with fixed full coverage prosthesis
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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Outcome Following Endodontic Treatment Using Traditional Access Versus Conservative Access

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