To check the effectiveness of four different pit and fissures sealants in preventing the decay of teeth

Phase 4

Not yet recruiting

Conditions: Other Procedures,

Registration Number: CTRI/2022/01/039183

Lead Sponsor: Dr Jyoti Solanki

Brief Summary: The current study is randomized, double blind ,split mouth trial which is designed to evaluate the clinical efficacy of resin infiltrant( ICON) and compare its efficacy in prevention of pits and fissures caries with other two commercially available fissure sealants and also to evaluate its efficacy in combination with flowable nanohybrid composite resin. The primary outcomes measures will be change in clinical ICDAS scores for pit and fissure surfaces and change in laser fluorescence scores (DIAGNOdent pen) for pit and fissure surfaces. The secondary outcomes measures will be marginal integrity and marginal discoloration of four different sealant groups. All outcomes shall be observed at baseline , three months and six months post intervention for each patient.

**Aim**- To evaluate and compare clinical efficacy of four different pit and fissure modalities, viz, resin infiltrant (ICON),moisture tolerant fissure sealant(EW), flowable nanohybrid composites (Tetric N flow) and ICON and Tetric N flow combinational group in young permanent molars.

**Objectives** -1. To evaluate and compare caries progression among four different pit and fissure sealant modalities using ICDAS diagnostic criteria.

2. To clinically assess and compare caries progression among four different pit and fissure modalities in using laser florescence (Diagnodent pen) during follow ups.

3. To evaluate and compare the marginal integrity and marginal integrity of four different pit and fissure sealant modalities.

**Study Groups** - 1. infiltrant resin (ICON)

2. moisture tolerant resin based sealant (Embrace wetbond)

3. flowable nanohybrid composite(Tetric N flow)

4. ICON and Tetric N flow combination

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 33

Inclusion Criteria

Questionable pits and fissures in permanent mandibular or maxillary first molars with age of child ranging from 6 to 10 years.
Questionable pits and fissures in permanent mandibular or maxillary second molars with age of child ranging from 11 to 14 years.
Sound, Non cavitated grade 0,1 or 2 caries according to the international caries detection and assessment system ICDAS caries diagnostic criteria.

Exclusion Criteria

1.Children with hypoplastic permanent first/second molar.
2.Children with proximal caries in molars.
3.Occlusal carious lesions more than grade 2 according to ICDAS caries diagnostic criteria.
4.Teeth with developmental anomalies such as fluorosis etc.
5.Children with systemic disorders.
6.Previously placed sealants or restorations on molar teeth.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â€¢Change in clinical ICDAS scores for pit and fissure surfaces.	At baseline, 3 months and 6 months
â€¢Change in laser fluorescence scores (DIAGNOdent pen) for pit and fissure surfaces.	At baseline, 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
â€¢Marginal integrity and Marginal discoloration of four different sealant modalities.	At baseline, 3 months and 6 months

Trial Locations

Locations (1): King Georges Medical University
🇮🇳
Lucknow, UTTAR PRADESH, India
King Georges Medical University
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Jyoti Solanki
Principal investigator
8979585728
jyotisolanki899@gmail.com