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Completed

NCT Number: NCT03130725

Retention of Bonded Amalgam Sealants Versus Resin-based Sealants

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

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University

Karachi, Sindh, 74800, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Amalgam sealant

Procedure

Amalgam sealant placed on incipient enamel caries and deep enamel fissures.

Resin based sealant

Procedure

Resin based sealant placed on incipient enamel caries and deep enamel fissures.

Primary outcomes

  1. Retention of sealant

    Time frame: Six months

    • Complete retention, if the all the occlusal fissures were covered by the sealant.
    • Partial retention, if some of occlusal fissures of a tooth showed loss of sealant.
    • Complete failure, if sealant was missing from all the occlusal fissure of the tooth.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 26, 2017
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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