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Retention of Bonded Amalgam Sealants Versus Resin-based Sealants

Primary Purpose

Incipient Enamel Caries, Fissure, Dental

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Amalgam sealant
Resin based sealant
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Incipient Enamel Caries

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Aga Khan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Amalgam sealant

Resin based sealant

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2017
Last Updated
June 27, 2018
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT03130725
Brief Title
Retention of Bonded Amalgam Sealants Versus Resin-based Sealants
Official Title
Comparison of Six Months Retention of Bonded Amalgam Sealants Versus Resin-based Sealants: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incipient Enamel Caries, Fissure, Dental

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amalgam sealant
Arm Type
Experimental
Arm Description
Amalgam sealant placed on incipient enamel caries and deep enamel fissures.
Arm Title
Resin based sealant
Arm Type
Active Comparator
Arm Description
Resin based sealant placed on incipient enamel caries and deep enamel fissures.
Intervention Type
Procedure
Intervention Name(s)
Amalgam sealant
Intervention Description
Amalgam sealant placed on incipient enamel caries and deep enamel fissures.
Intervention Type
Procedure
Intervention Name(s)
Resin based sealant
Intervention Description
Resin based sealant placed on incipient enamel caries and deep enamel fissures.
Primary Outcome Measure Information:
Title
Retention of sealant
Description
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.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samreen L Khowaja, MSc
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sind
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35202361
Citation
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.
Results Reference
derived

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Retention of Bonded Amalgam Sealants Versus Resin-based Sealants

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