Clinical trial NCT05791682: "Comparative Clinical Evaluation of Pit and Fissure Sealants on Permanent First Molar Teeth in Children."
Official 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."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: PITS AND FISSURE SEALANT
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 42
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion crieteria

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

EXCLUSION CRITERIA

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

Primary outcomes:
measure: To evaluate sealant retention
timeFrame: 9 months
Secondary outcomes:
measure: To evaluate marginal integrity
timeFrame: 9 months
measure: to evaluate anti caries effect
timeFrame: 9 months
measure: to evaluate colour change
timeFrame: 9 months
measure: to evaluate surface roughness
timeFrame: 9 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post graduate institute of dental sciences
state: Haryana
Study officials:
References: