Completed

NCT Number: NCT05791682

"Comparative Clinical Evaluation of Pit and Fissure Sealants on Permanent First Molar Teeth in Children."

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.

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Key information

Conditions

PITS AND FISSURE SEALANT

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Post graduate institute of dental sciences

Rohtak, Haryana, 124001, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion crieteria

Normal healthy children aged 7 to 10 years.
Subjects who are not undergoing any other preventive dental health treatment.
Availability for the duration of the study.
Satisfactory dental care performed at home.
The willingness of the patient to accept the treatment.
All four first permanent molars that have completely erupted with deep pits and fissures.
Fissures either intact, sound or retentive which are stained, caries free or ICDAS 0-2.

Exclusion criteria

Children whose parents will not give informed consent.
Special child, a child with compromised systemic health.
Long-term medication affecting the salivary flow.
Children enrolled for other studies or fluoridation program.
Adverse reaction reported to any dental material.
Uncooperative child.
Bruxism or malocclusion.
Children with developmental defects/ hypoplastic molars or caries affected teeth (ICDAS>2).
Teeth with restoration and partially retained sealants.
Children who cannot come for the follow-up.

Treatment and study plan

Sealant, Fissure

Drug

FISSURIT FX- MICROFILLED RESIN SEALANT WITH 55% FILLER GRANDIOSEAL- NANOFILLED RESIN SEALANT WITH 70% FILLER TE-ECONOM- FLOW -FLOWABLE COMPOSITE AS SEALANT CLINPRO TM- UNFILLED RESIN SEALANT

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

Time frame: 9 months

Alpha- No visible evidence of a crevice along the margin of the sealant that the explorer could penetrate.

Bravo- Visible evidence of a crevice along the margin of the sealant that the explorer could penetrate.
to evaluate anti caries effect

Time frame: 9 months

Alpha- Sound fissures. Bravo- Fissures with caries.
to evaluate colour change

Time frame: 9 months

Alpha- No discoloration anywhere on the margin around the sealant. Bravo- Visible partial discoloration the margin around sealant. Charlie- Visible discoloration on the margin around all sealant.
to evaluate surface roughness

Time frame: 9 months

Alpha- The sealant is similar to polished enamel. Bravo- The sealant surface is similar to composite material surface contained submicron filler.

Charlie- The surface is rough that prevents the explorer movement along the surface.

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Registry information

Official study title

"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."

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Mar 30, 2023
Registry last updated: Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.