Retention of Bonded Amalgam Sealants Versus Resin-based Sealants

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Incipient Enamel Caries, Fissure, Dental

Intervention / Treatment
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* Procedure: Amalgam sealant
* Procedure: Resin based sealant


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention of sealant | 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. | Six months |