PITS AND FISSURE SEALANT
Conditions
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.
Interventions
DRUGSealant, Fissure
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
Sponsors
Postgraduate Institute of Dental Sciences Rohtak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate sealant retention | 9 months | Alpha - complete retention Bravo- partial retention Charlie- no retention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate marginal integrity | 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 | 9 months | Alpha- Sound fissures. Bravo- Fissures with caries. |
| to evaluate colour change | 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 | 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. |
Countries
India
Outcome results
None listed