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

Postgraduate Institute of Dental Sciences Rohtak42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

PITS AND FISSURE SEALANT

Eligibility

Sex: ALLMin age: 7 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

To evaluate sealant retention

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

Time frame: 9 months

Secondary Outcomes

To evaluate marginal integrity

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.

Time frame: 9 months

to evaluate anti caries effect

Alpha- Sound fissures. Bravo- Fissures with caries.

Time frame: 9 months

to evaluate colour change

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.

Time frame: 9 months

to evaluate surface roughness

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.

Time frame: 9 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes