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A Study on the Strength and Color Changes of Sealants in childrens Teeth

Comparative Assessment of Retention and Discoloration of Pit and Fissure Sealants in Children - In vivo study. - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/0103116
Enrollment
30
Registered
2026-02-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: Group 1- Tooth 16 PF Seal without bonding agent Group 2 - Tooth 26 PF Seal with bonding agent Group 3 -Tooth 36 protec without bonding agent Group 4:Tooth 46 protec with bonding agen

Sponsors

saveetha dental college and hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 7 15 years with mixed dentition. Presence of all four fully/partially erupted permanent first molars suitable for sealant placement. Molars with deep pits and fissures or ICDAS 0 2 non-cavitated lesions, but without cavitation or restorations. Clinically and radiographically sound teeth vital, asymptomatic, and free from proximal dentinal caries. Medically healthy, cooperative children with parental consent and willingness for follow-up visits.

Exclusion criteria

Exclusion criteria: Children with systemic illnesses, special healthcare needs, or developmental enamel/dentin defects (e.g., MIH, fluorosis). Permanent first molars with cavitated caries, restorations, hypoplasia, or previous sealant application. Teeth with pulpal symptoms, periapical pathology, or radiographic evidence of dentinal/proximal caries. Children unable to maintain adequate isolation or moisture control during sealant placement. Uncooperative children or those without parental consent/follow-up compliance.

Design outcomes

Primary

MeasureTime frame
Retention rate of pit and fissure sealants on all four permanent first molars, assessed at periodic intervals (3,6 months) using standardized retention criteria (fully retained, partially lost, completely lost). Discoloration of sealants, evaluated clinically by visual comparison with baseline shade (using a standardized shade guide or scoring system) at the same follow-up intervals.Timepoint: 3,6 , 12 months

Secondary

MeasureTime frame
Marginal integrity and surface wear of the sealants, evaluated clinically using modified USPHS/FDI criteria at each follow-up. Caries incidence on sealed occlusal surfaces, assessed by ICDAS codes and radiographic confirmation when needed. Marginal discoloration and patient acceptability, recorded using a standardized visual scoring system and simple parent/child feedback.Timepoint: 3,6 , 12 months

Countries

India

Contacts

Public ContactRasika Pavan Chandak

Saveetha dental college

152411004.sdc@saveetha.com07038376379

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026