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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amalgam sealant | Experimental | Amalgam sealant placed on incipient enamel caries and deep enamel fissures. |
|
| Resin based sealant | Active Comparator | Resin based sealant placed on incipient enamel caries and deep enamel fissures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amalgam sealant | Procedure | Amalgam sealant placed on incipient enamel caries and deep enamel fissures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention of sealant |
| Six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samreen L Khowaja, MSc | Aga Khan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University | Karachi | Sindh | 74800 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35202361 | Derived | Khan FR, Liaquat S, Rafique G, Azam SI, Hasan A. Bonded amalgam as a fissure sealant in low-income setting: A randomised controlled trial. J Pak Med Assoc. 2022 Feb;72(Suppl 1)(2):S3-S9. doi: 10.47391/JPMA.AKU-02. |
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| ID | Term |
|---|---|
| D003750 | Dental Fissures |
| ID | Term |
|---|---|
| D014071 | Tooth Abnormalities |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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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.
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| Resin based sealant | Procedure | Resin based sealant placed on incipient enamel caries and deep enamel fissures. |
|