Effect of Various Sealers on Healing of Teeth With Apical Periodontitis

October 14, 2018 updated by: Postgraduate Institute of Dental Sciences Rohtak

Effect of Various Sealers on Healing of Teeth With Apical Periodontitis: A Clinical Study

This study will compare the effect of three different sealers on healing of teeth with apical periodontitis after primary root canal treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Various sealers with different chemical composition and properties are available but it is yet not clear if one sealer is superior to other in terms of healing of apical periodontitis.

Three different groups of sealers will be used- a zinc oxide based sealer, an epoxy resin based sealer and a bioactive silicone based sealer. Mature mandibular permanent molar with the diagnosis of apical periodontitis (as confirmed clinically & by periapical radiograph) will be chosen for the study. Primary non surgical root canal treatment will be performed. The sealer will be randomly selected just before obturation of root canals. The patient will be allotted to one of the three groups.

  • Group I: Zinc oxide eugenol sealer group. The material will be mixed according to manufacturer instructions and applied to canals using a lentulospiral and the obturation will be performed.
  • Group II: Epoxy resin based sealer group. The material will be mixed according to the manufacturer's instructions and obturation will be done.
  • Group III: Bioactive silicone based sealer: The material will be used according to the manufacturer's instruction and obturation will be performed

Study Type

Interventional

Enrollment (Actual)

99

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

  • India
    • Haryana
      • Rohtak, Haryana, India, 124001
        • Post Graduate Institute of Dental Sciences

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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The inclusion criteria of the study will include:

  • Patient willing to participate in the study.
  • Age >18 years.
  • No history of antibiotic use within the past month or requiring antibiotic premedication
  • No history of prior analgesic use during past 24 hrs.
  • Mature permanent mandibular molar having apical periodontitis requiring primary root canal treatment.
  • There must be a radiographic evidence of periapical radiolucency (minimum size 2mmx2mm) and a diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber

Exclusion Criteria:

  • Re-treatment
  • Unwillingness of patients
  • The presence of a difficult canal anatomy (root canals with an extreme curvature ≥30 deg), internal or external resorption and immature teeth.
  • Accident or complication during treatment (calcified canals ,inability to achieve apical patency in any canals) Immuno-compromised, diabetic, pregnant and hypertensive patients.
  • Teeth that are peridontally compromised

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: Zinc oxide based sealer
After root canal treatment obturation with gutta percha will be done using zinc oxide based sealer.
Procedure: Zinc oxide based sealer
After root canal treatment obturation will be done using zinc oxide eugenol based sealer.
Experimental: Epoxy resin based sealer
After root canal treatment obturation with gutta percha will be done using epoxy resin based sealer.
Procedure: Epoxy resin based sealer
After root canal treatment obturation will be done using epoxy resin based sealer.
Experimental: Bioactive silicone based sealer
After root canal treatment obturation with gutta percha will be done using bioactive silicone based sealer.
Procedure: Bioactive silicone based sealer
Other Names:
  • After root canal treatment obturation will be done using bioactive silicone based sealer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic success
Time Frame: 12 months
Change in apical bone density will be measured by Periapical Index (PAI) score. PAI score equal to or less than 2 will be categorized as success.
12 months
Clinical success
Time Frame: 12 months
Absence of pain, sinus tract, swelling and mobility.
12 months

Collaborators and Investigators

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

Sponsor

Postgraduate Institute of Dental Sciences 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)

November 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

December 31, 2017

First Submitted That Met QC Criteria

January 5, 2018

First Posted (Actual)

January 12, 2018

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 14, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aparna Tripathi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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