Outcome Following Endodontic Treatment Using Traditional Access Versus Conservative Access

NCT05402098 | Unknown DMC

• 1 other identifier: A Ramani
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Pulpitis - Irreversible

Keywords

Irreversible pulpitis; Endodontic treatment; Traditional access; Conservative access; Contracted endodontic cavities

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12 Months

Secondary Outcomes (1)

• Pain analysis

  Baseline to 7 days

Study Arms (2)

Endodontic treatment using traditional access

ACTIVE COMPARATOR

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

Procedure: Endodontic treatment using traditional access

Endodontic treatment using conservative access

EXPERIMENTAL

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

Procedure: Endodontic treatment using conservative access

Interventions

Endodontic treatment using traditional access PROCEDURE

Endodontic treatment will be carried out following complete removal of pulp chamber roof and achieving straight line access

Endodontic treatment using traditional access

Endodontic treatment using conservative access PROCEDURE

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

Endodontic treatment using conservative access

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Dr. Ankita Ramani

Rohtak, Haryana, 124001, India

RECRUITING

Study Officials

• DR. ANKITA RAMANI, MDS

  PGIDS, ROHTAK, HARYANA, INDIA-124001

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DR. ANKITA RAMANI, MDS

CONTACT

+919582841539; ramaniankita95@gmail.com

DR. PANKAJ SANGWAN, MDS

CONTACT

9996112202; drps_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 2, 2022
• Study Start: May 12, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)