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

NCT02408601 | Completed Phase 2

• 1 other identifier: KamineniIDS
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• retention rate as given by the simonsons criteria

  24 months

Secondary Outcomes (1)

• caries incidence

  24 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

split mouth study. one side of the arch that is the lower left permanent 1st molar will be receiving resin based sealants. Application of the resin sealants as per the standard instructions of the manufacturer 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 accepted 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: Helioseal - F

Group 2

EXPERIMENTAL

split mouth study. one side of the arch that is the lower right permanent 1st molar will be receiving ART sealants. Application of the ART sealants as per the standard instructions of the manufacturer 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.

Other: ART sealant

Interventions

Helioseal - F OTHER

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

Group 1

ART sealant OTHER

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.

Group 2

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children belonging to high caries risk group
• st permanent molars with an exaggerated pit and fissure system

You may not qualify if:

• non cooperative children excluded
• children with history of systemic diseases
• parents haven't given their consent for this preventive therapy

Sponsors & Collaborators

• Dr. Praveen B.H: lead
• Kamineni Institute of Dental Sciences: collaborator

Study Sites (1)

Divya Bala School

Bhongir, Andhra Pradesh, 508116, India

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Praveen Haricharan Bhoopathi, M.D.S

  Kamineni Institute of Dental Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: A randomized controlled clinical trial to assess the retention and caries preventive effect of Resin based sealant versus ART sealant among the 6-12 yr old school children of a district in India. A 24 months follow up study.

Study Record Dates

• First Submitted: March 24, 2015
• First Posted: April 3, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

IN (1)