Outcome Following Endodontic Treatment Using Traditional Access Versus Conservative Access

NCT ID: NCT05402098

Last Updated: 2022-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Endodontic treatment using traditional access

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

Group Type ACTIVE_COMPARATOR

Endodontic treatment using traditional access

Intervention Type PROCEDURE

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

Endodontic treatment using conservative access

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

Group Type EXPERIMENTAL

Endodontic treatment using conservative access

Intervention Type 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

Interventions

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Endodontic treatment using traditional access

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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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DR. ANKITA RAMANI, MDS

Role: PRINCIPAL_INVESTIGATOR

PGIDS, ROHTAK, HARYANA, INDIA-124001

Locations

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Dr. Ankita Ramani

Rohtak, Haryana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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DR. ANKITA RAMANI, MDS

Role: CONTACT

+919582841539

DR. PANKAJ SANGWAN, MDS

Role: CONTACT

9996112202

Facility Contacts

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DR. ANKITA RAMANI, MDS

Role: primary

09582841539

Other Identifiers

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A Ramani

Identifier Type: -

Identifier Source: org_study_id

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