Evaluation of Three Irrigants, Sodium Hypochlorite, Chlorhexidine and Combination of CHX+H2O2 in Endodontic Treatment.

NCT ID: NCT04373018

Last Updated: 2020-05-04

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-04-30

Brief Summary

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This study will evaluate the synergistic effect of CHX + H2O2 when used as an irrigant during biomechanical preparation.in root canal treatment on periapical healing and compared with Chlorhexidine( CHX) and Sodium Hypochlorite (NaOCl).

Detailed Description

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After a thorough history, clinical and radiographic examination with all eligibility confirmation, written informed consent will be taken from the patient after explaining the procedure and its associated risks and benefits. Patients randomly allocated to one of the three study groups Sodium hypochlorite (NaOCl), Chlorhexidine (CHX) and combination of (CHX+H2O2). All three irrigants will be used according to standard protocol during biomechanical preparation. Pain analysis will be carried out preoperatively and postoperatively at every 6 hours for 1 day and then every 24 hours till 7 days after the intervention. All the subjects will be followed up for evaluation of clinical and radiographic success at 3, 6 months and 1year.

Conditions

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Periapical Periodontitis

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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Sodium hypochlorite

Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using Sodium hypochlorite during biomechanical preparation.

Group Type ACTIVE_COMPARATOR

Sodium hypochlorite

Intervention Type PROCEDURE

Sodium hypochlorite irrigant will be used during biomechanical preparation.

Chlorhexidine

Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using Chlorhexidine during biomechanical preparation.

Group Type ACTIVE_COMPARATOR

Chlorhexidine

Intervention Type PROCEDURE

Chlorhexidine irrigant will be used during biomechanical preparation.

Chlorhexidine + Hydrogen peroxide

Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using a combination of Chlorhexidine + Hydrogen peroxide during biomechanical preparation.

Group Type EXPERIMENTAL

Chlorhexidine + Hydrogen peroxide

Intervention Type PROCEDURE

Chlorhexidine + Hydrogen peroxide irrigant will be used during biomechanical preparation.

Interventions

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Sodium hypochlorite

Sodium hypochlorite irrigant will be used during biomechanical preparation.

Intervention Type PROCEDURE

Chlorhexidine

Chlorhexidine irrigant will be used during biomechanical preparation.

Intervention Type PROCEDURE

Chlorhexidine + Hydrogen peroxide

Chlorhexidine + Hydrogen peroxide irrigant will be used during biomechanical preparation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients over 18 years of age.
* Mature permanent mandibular molars.
* A radiographic evidence of periapical radiolucency (minimum size \> 2mm×2mm) and a diagnosis of pulpal necrosis, as confirmed by the negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber.

Exclusion Criteria

* Diabetics, immunocompromised patients, pregnant females, any systemic disease.
* Patients with a history of analgesic intake within the past 3 days and antibiotics in the last month.
* Patients with pockets ≥ 4mm or having marginal or furcal bone loss due to periodontitis.
* Non-restorable tooth, fractured, perforated roots and inflammatory root resorption.
* Teeth those are not suitable for rubber dam isolation.
* Primary teeth.
Minimum Eligible Age

18 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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Anshu Yadav

Role: PRINCIPAL_INVESTIGATOR

PGIDS, Rohtak

Locations

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PGIDS, Rohtak

Rohtak, Haryana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Anshu Yadav

Role: CONTACT

9050522830

Dr Vinay Kumar

Role: CONTACT

8901149107

Facility Contacts

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Dr Vinay Kumar

Role: primary

8901149107

Anshu Yadav

Role: backup

9050522830

Other Identifiers

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anshuyendo

Identifier Type: -

Identifier Source: org_study_id

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