MedTrace Logo

A Clinical Trial to Assess the Retention and Caries Preventive Effect of Resin Based Sealants Versus ART Sealants

NCT02408601 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2021-01-06

No results posted yet for this study

Summary

Background and study aims:

The investigators are carrying out a clinical trial of two different sealant materials to compare the retentivity and decay inhibiting properties of the above said materials. it is a split mouth study, wherein the 2 sealant materials will be placed on the exactly opposite placed molars of 198 healthy school children in the age group between 6 - 12 yrs of age.

who can participate? school children in the age group between 6 - 12 yrs of age with non decayed contra lateral permanent 1st molars at a school in the southern part of India.

what does the study involve? over a period of 24 months, the retentivity and the decay preventing effects of these two sealant materials( RESIN BASED SEALANTS AND ART SEALANTS) will be clinically assessed by us.

possible benefits/ risks of participating in the trial the participants will be not be exposed to any kind of risks as it is a non invasive procedure the possible benefits may be preventing decay to the permanent molar in the long run

study start date/duration of the study? MARCH 2015 is the month wherein the sealant applications have started and expected to last till the April of 2017

funding? self funded study

Conditions

  • Dental Caries

Interventions

OTHER

Helioseal - F

Helioseal -F ( Resin based sealant) 1. isolate the tooth surface 2. etch the fissure anatomy with 37% phosphoric acid for 20 seconds 3. wash the tooth surface and dry it. No salivary contamination is accepeted 4. using a syringe based system, apply the sealant onto the fissures, do not overfill the fissures, run an explorer along the fissures to avoid any air entrapment. 5. light cure the sealant 6. check for high points and the occlusion

OTHER

ART sealant

Fuji IX extra strength 1. isolate the tooth surface 2. condition the fissure anatomy using a GC conditioner for 10 seconds 3. wash the conditioner by using a cotton pellet for a couple of times, do not use a three way syringe. 4. dry the tooth surface 5. mix the GIC according to the standard powder: liquid ratio 6. place the mix onto the fissures using a plastic spatula 7. apply pressure on the occlusal surface with a gloved index finger( the gloved index finger must be coated with petroleum jelly) 8. apply pressure for 10-15 sec and withdraw the finger in a sideways motion 9. scrap out the excess material 10. check for the high points and the occlusion 11. apply petroleum jelly onto the GIC mix 12. advice patient not to eat or drink for 30 minutes.

Sponsors & Collaborators

  • Kamineni Institute of Dental Sciences

    collaborator OTHER

  • Dr. Praveen B.H

    lead OTHER

Principal Investigators

  • Praveen Haricharan Bhoopathi, M.D.S · Kamineni Institute of Dental Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • India

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02408601 on ClinicalTrials.gov