Retention of Bonded Amalgam Sealants Versus Resin-based Sealants

June 27, 2018 updated by: Farhan Raza Khan, Aga Khan University

Comparison of Six Months Retention of Bonded Amalgam Sealants Versus Resin-based Sealants: A Randomized Controlled Trial

Dental caries, is one of the major public health problem in Pakistan. Dental sealants are known cost effective preventive measure of dental caries as compared to other preventive measures. Resin based sealants, is a proven treatment of pits and fissure sealants but retention is still problem. This trial will assess the use of amalgam sealants as an effective and retentive preventive measure in preventing dental caries in children as compared to the standard resin-based sealants. The findings of this randomized controlled trial will be used to raise awareness among the health care professionals, help them to choose amalgam sealants as an effective caries prevention method thereby reducing the burden of cost as amalgam is cheaper material compared to resin-based sealants.

The research question Is there any difference in the six months retention of bonded amalgam sealants compared to resin-based sealants among 12 to 16 years old children in Karachi

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective:

To compare the six month retention of bonded amalgam sealants with that of resin-based sealants among 12 to 16 year old children in Karachi

Methods:

The study design will be parallel group, equivalence randomized controlled trial. Aim is to determine the equality of the Amalgam sealants retention compared to resin based sealants retention.

Outcome:

The primary outcome will be Retention, divided into Complete Retention, Partial Retention and Dislodgement of the sealant material.

Study Type

Interventional

Enrollment (Actual)

51

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

  • Pakistan
    • Sind
      • Karachi, Sind, Pakistan, 74800
        • Aga Khan University

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

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children of aged 12 to 16 years (male and female) who will visit to the study site and fulfilled the eligibility criteria
  • Teeth should be caries free at the time of sealants placement. As Dental sealant is a preventive treatment it is placed in a caries free surface. Incipient carious lesions will also be included.
  • Teeth should be completely erupted, as incomplete eruption of teeth is highly correlates to the partial retention of sealants.
  • Children who will give assent to participate in a study and their parents will give consent.

Exclusion Criteria:

  • Special needs children (because they need special attention of parents)
  • Children who have blood disorder like (leukemia, lymphoma, and thalassemia)
  • Persons with impaired vision, speech and hearing (because either they may not be able to respond to questionnaire or conducting baseline dental training will be difficult).

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amalgam sealant
Amalgam sealant placed on incipient enamel caries and deep enamel fissures.
Procedure: Amalgam sealant
Amalgam sealant placed on incipient enamel caries and deep enamel fissures.
Active Comparator: Resin based sealant
Resin based sealant placed on incipient enamel caries and deep enamel fissures.
Procedure: Resin based sealant
Resin based sealant placed on incipient enamel caries and deep enamel fissures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention of sealant
Time Frame: Six months
  1. Complete retention, if the all the occlusal fissures were covered by the sealant.
  2. Partial retention, if some of occlusal fissures of a tooth showed loss of sealant.
  3. Complete failure, if sealant was missing from all the occlusal fissure of the tooth.
Six months

Collaborators and Investigators

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

Sponsor

Aga Khan University

Investigators

  • Principal Investigator: Samreen L Khowaja, MSc, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2017

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

April 22, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4445-CHS-ERC-16

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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