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Clinical Trials/NCT05791682
NCT05791682
Completed
Phase 3

"Comparative Clinical Evaluation of Microfilled Resin Sealant, Nanofilled Resin Sealant and Flowable Composite as Sealant With Unfilled Resin Sealant on Permanent First Molar Teeth in Children."

Postgraduate Institute of Dental Sciences Rohtak1 site in 1 country42 target enrollmentApril 2, 2021

Overview

Phase
Phase 3
Intervention
Sealant, Fissure
Conditions
PITS AND FISSURE SEALANT
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
Enrollment
42
Locations
1
Primary Endpoint
To evaluate sealant retention
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Study was aimed to evaluate and compare clinical efficacy of the Microfilled resin sealant, Nanofilled resin sealant, Flowable composite as sealant, with Unfilled resin sealant on first permanent molar in children at 9 months follow ups.

Children (age 7 to 10) with deep pits and fissures, (ICDAS 0-2) included in the study and study was Split mouth randomized controlled clinical trial.

Sample size- Total number of 42 patients will be recruited in the study, with 42 first permanent molars in each group.

Methods-Patients were seated in supine position on the dental chair and cotton rolls will be applied for isolation. The first permanent molar in each group was treated as follows:

Group 1 -Intervention with Microfilled resin sealant. Group 2- ¬Intervention with Nanofilled resin sealant. Group 3 -Intervention with Flowable composite as sealant. Group 4 - ¬Intervention with Unfilled resin sealant. Patients and their parents were received instructions for daily brushing and oral hygiene maintenance. Sealant clinical efficacy was evaluated at 3, 6 and 9 month recall visit.

OUTCOME MEASURES:

  1. Primary outcomes: To evaluate sealant retention, anticaries effect and marginal integration.
  2. Secondary outcomes: to evaluate, colour change and surface roughness of sealant.
Registry
clinicaltrials.gov
Start Date
April 2, 2021
End Date
November 5, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

MICROFILLED RESIN SEALANT

-Microfilled rein sealant (fissurit FX) after etching, washing, drying, sealant was gradually applied along the fissure of first permanent molar, Immediately light cured for 20 sec

Intervention: Sealant, Fissure

NANOFILLED RESIN SEALANT

Nanofilled resin sealant (Grandioseal) after etching, washing, drying, sealant was gradually applied along the fissure. Immediately light cured for 20 sec.

Intervention: Sealant, Fissure

FLOWABLE COMPOSITE

Flowable composite (Te-Econom Flow) after etching, washing, drying, adhesive was applied and dried under gentle air flow for 2-3 sec and was light cured. A uniform layer of flowable composite was applied and light cure for 20 sec.

Intervention: Sealant, Fissure

UNFILLED RESIN SEALANT

Unfilled resin sealant (clinpro) after etching, washing, drying, sealant will be gradually applied along the fissure. Immediately light cure for 20 sec.

Intervention: Sealant, Fissure

Outcomes

Primary Outcomes

To evaluate sealant retention

Time Frame: 9 months

Alpha - complete retention Bravo- partial retention Charlie- no retention

Secondary Outcomes

  • To evaluate marginal integrity(9 months)
  • to evaluate anti caries effect(9 months)
  • to evaluate colour change(9 months)
  • to evaluate surface roughness(9 months)

Study Sites (1)

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