Skip to content

Evaluation of clinical performance of moisture tolerant sealant on pit and fissure caries in two different clinical settings.

Evaluation of clinical performance of moisture tolerant sealant on pit and fissure caries in two different setting conditions: a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068418
Enrollment
55
Registered
2024-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

None listed

Interventions

Intervention1: Moisture Tolerant Pit & Fissure Sealant (Embrace WetBond): Moisture Tolerant Pit & Fissure Sealant in normal field setting (non moisture controlled setting) applied in single sitting on

Sponsors

Dr Shweta Dangi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Questionable, non cavitated, bilateral pits and fissures in permanent maxillary or mandibular first molars with age of child ranging from 6 to 10 years. 2. Questionable, non cavitated, bilateral pits and fissures in permanent maxillary or mandibular second molars with age of child ranging from 11 to 14 years. 3. Stained or minimal decalcified appearance of pits and fissures in molars. 4. Children who are willing to attend the scheduled follow ups.

Exclusion criteria

Exclusion criteria: 1. Children who had enamel defects such as amelogenesis imperfecta, enamel hypoplasia and dental fluorosis. 2. The occlusal surface of molars having shallow pit and fissures, which are self-cleansing in the oral cavity for more than 4 years. 3. Molars with caries in the proximal surfaces. 4. Previously placed sealants or restorations on molar teeth. 5. Uncooperative children.

Design outcomes

Primary

MeasureTime frame
Retention rateTimepoint: Retention rate using modified Ryge criteria/United States Public Health Service (USPHS)for Direct Clinical Evaluation of Restorations criteria at 1 month, 6 months and 12 months

Secondary

MeasureTime frame
Caries FormationTimepoint: Caries Formation using modified Ryge criteria/United States Public Health Service (USPHS)for Direct Clinical Evaluation of Restorations criteria at 1 month, 6 months & 12 months;Marginal DiscolorationTimepoint: Marginal Discoloration using modified Ryge criteria/United States Public Health Service (USPHS)for Direct Clinical Evaluation of Restorations criteria at 1 month, 6 months & 12 months;Marginal AdaptationTimepoint: Marginal Adaptation using modified Ryge criteria/United States Public Health Service (USPHS)for Direct Clinical Evaluation of Restorations criteria at 1 month, 6 months & 12 months;Color MatchTimepoint: Color Match using modified Ryge criteria/United States Public Health Service (USPHS)for Direct Clinical Evaluation of Restorations criteria at 1 month, 6 months & 12 months;Smoothness of SurfaceTimepoint: Smoothness of Surface using modified Ryge criteria/United States Public Health Service (USPHS)for Direct Clinical Evaluation of Restorations criteria at 1 month, 6 months & 12 months

Countries

India

Contacts

Public ContactDr Shweta Dangi

NIMS Dental College & Hospital, Jaipur, Rajasthan

rajsushil.chhabra@gmail.com09467523908

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026