Retention of Bonded Amalgam Sealants Versus Resin-based Sealants

NCT03130725 | Completed DMC

• 1 other identifier: 4445-CHS-ERC-16
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

Incipient Enamel Caries; Fissure, Dental

Outcome Measures

Primary Outcomes (1)

• Retention of sealant

  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

Study Arms (2)

Amalgam sealant

EXPERIMENTAL

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

Procedure: Amalgam sealant

Resin based sealant

ACTIVE COMPARATOR

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

Procedure: Resin based sealant

Interventions

Amalgam sealant PROCEDURE

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

Amalgam sealant

Resin based sealant PROCEDURE

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

Resin based sealant

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 35202361 DERIVED

MeSH Terms

Conditions

Dental Fissures

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Samreen L Khowaja, MSc

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 22, 2017
• First Posted: April 26, 2017
• Study Start: February 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: June 28, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)