Comparative Evaluation of Hydrophilic and Hydrophobic Sealants in Partially Erupted First Molars

Condition(s) studied

Investigational drug(s) / intervention(s)

Prevention: Conventional Hydrophobic Sealant (Helioseal F - Control) will be used as a positive control; applied to partially erupted molars with and without bonding in a split-mouth design.

Prevention of caries: Embrace WetBond sealant will be applied to partially erupted first permanent molars using a split-mouth design with and without bonding agent.

Prevention therapy: DENU Seal applied using a split-mouth design to evaluate bonding and non-bonding application outcomes from retention and caries prevention

Study summary

This randomized controlled clinical trial aims to evaluate and compare the retention, caries prevention, microleakage, and fluoride release of three types of pit and fissure sealants-hydrophilic, nanofilled hydrophobic, and conventional hydrophobic-applied to partially erupted first permanent molars in children aged 5 to 7 years. The study uses a split-mouth design and includes both clinical and laboratory evaluations over an 18-month period. Outcomes will assess sealant effectiveness with and without the use of a bonding agent.

Eligibility

Primary outcome measure(s)

• Retention — 18 months
  retention is evaluated using CCC Index (Color, Coverage, and Caries) This scale is used to assess sealant retention and caries status during follow-up evaluations. Score Description Retention Caries Status Interpretation 0 Sealant completely retained no caries Full retention Best outcome 1. Partial sealant loss no caries Partial loss Acceptable 2. Sealant completely lost no caries Total loss Less ideal 3. Sealant partially or totally lost caries present Partial or total loss Worst outcome
• Caries — 18 months
  Caries Incidence: 3, 6, 12, 18 months, t each recall (3, 6, 12 months), evaluate each sealed tooth using the CCC score: If the sealant is completely intact and no caries is visible → score = 0 If the sealant is partially gone but no decay → score = 1 If sealant is lost but still no decay → score = 2 If sealant is lost/partial and there is decay → score = 3

Trial sites (1)

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