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

April 29, 2020 updated by: Postgraduate Institute of Dental Sciences Rohtak

Comparative Evaluation of Clinical and Radiographic Outcome by Using Three Different Irrigants, Sodium Hypochlorite (NaOCl), Chlorhexidine (CHX) and Combination of CHX+H2O2 in Primary Endodontic Treatment

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sodium hypochlorite
Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using Sodium hypochlorite during biomechanical preparation.
Procedure: Sodium hypochlorite
Sodium hypochlorite irrigant will be used during biomechanical preparation.
Active Comparator: Chlorhexidine
Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using Chlorhexidine during biomechanical preparation.
Procedure: Chlorhexidine
Chlorhexidine irrigant will be used during biomechanical preparation.
Experimental: Chlorhexidine + Hydrogen peroxide
Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using a combination of Chlorhexidine + Hydrogen peroxide during biomechanical preparation.
Procedure: Chlorhexidine + Hydrogen peroxide
Chlorhexidine + Hydrogen peroxide irrigant will be used during biomechanical preparation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success
Time Frame: Base line to 1 year.

Absence of signs and symptoms Absence of tenderness to percussion Tooth mobility of grade 1 or less Absence of associated soft tissue swelling or tenderness to palpation Attachment loss of less than 5mm .

Two experienced observers with no knowledge of the treatment protocol will independently examine the immediate post obturation and follow up radiographs, mounted side by side, under controlled conditions. The treatment is considered successful only when both clinical and radiographic criteria are met. The worst outcome of an individual root decide the overall outcome for the tooth. In the event of disagreement, the two observers will meet to discuss their findings and came to an agreement.
Base line to 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic success
Time Frame: Baseline to 1 year

Absence of periapical alterations (radiolucency at furcal or periapical region) Scoring of each tooth will be done according to the following five point scale (PAI)

Score Description

  1. Normal Periapical structure
  2. Small changes in bone structure
  3. Changes in bone structure with some mineral loss
  4. Periodontitis with well defined radiolucent area
  5. Severe periodontitis with exacerbating features
Baseline to 1 year
Pain assessment
Time Frame: Baseline to 7 days
Assess the incidence and intensity of pain postoperatively at every 6 hours to 1 day till 7d ays using Visual Analogue scale.Pain intensity will be noted as no pain (0-4mm), mild pain (5-44), moderate pain (45-74mm) and severe pain (75-100mm) on the scale of 0-100mm
Baseline to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Investigators

  • Principal Investigator: Anshu Yadav, PGIDS, ROHTAK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

May 4, 2020

Study Record Updates

Last Update Posted (Actual)

May 4, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • anshuyendo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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