Outcome Following Endodontic Treatment Using Traditional Access Versus Conservative Access

Sponsor

Postgraduate Institute of Dental Sciences Rohtak (Other)

Overall Status

Recruiting

CT.gov ID

NCT05402098

Collaborator

(none)

Enrollment

Location

Arms

15.7

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pulpitis - Irreversible	Procedure: Endodontic treatment using traditional access Procedure: Endodontic treatment using conservative access	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 12, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Endodontic treatment using traditional access Straight line access will be achieved following complete removal of pulp chamber roof	Procedure: Endodontic treatment using traditional access Endodontic treatment will be carried out following complete removal of pulp chamber roof and achieving straight line access
Experimental: Endodontic treatment using conservative access 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 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

Arm

Intervention/Treatment

Active Comparator: Endodontic treatment using traditional access

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

Procedure: Endodontic treatment using traditional access

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

Experimental: Endodontic treatment using conservative access

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

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

Outcome Measures

Primary Outcome Measures

Clinical and radiographic success [Baseline to 12 Months]
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 [Baseline to 7 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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