The usage of different sealing materials for prevention of pit and fissure dental caries

The efficacy of different sealant modalities for prevention of pits and fissures caries. A randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15306760

Enrollment

Registered

2019-04-05

Start date

2016-08-25

Completion date

Unknown

Last updated

2020-11-16

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

Conditions

Pit and fissure dental caries Oral Health Dental caries

Interventions

The trial involved four groups of first permanent molars of schoolchildren aged 6-8 years. The study was carried out in a split-mouth design. Randomization: The selected molars were r

infiltrant resin (DMG Dental Materials, Hamburg, Germany) 2. Seal It

nanoparticle composite based pit and fissure sealant (Spident- 2115 Linwood Ave. Fort Lee – NJ07024) 3. GCP glass seal

nanoparticle glass ionomer-based pit and fissure sealant (GCP Dental | Boelewerf 32 | 2987 VD Ridderkerk) 4. The fourth group received a combination of resin infiltrant and composite r

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children free from systemic diseases 2. All four permanent first molars should be fully erupted 3. All molars had sound, non-cavitated grade 0, 1 or 2 caries according to ICDAS caries diagnostic criteria

Exclusion criteria

Exclusion criteria: 1. Children with hypo-plastic permanent first molar, proximal caries, occlusal carious lesions more than grade 2 or any developmental anomalies 2. Children who felt not to be sufficiently cooperative to allow sealant placement 3. Children with systemic disorders

Design outcomes

Primary

Measure	Time frame
Measured at 1, 3, 6, 12, 18 and 24 months: 1. Sealant retention evaluated according to a modified version of the Colour, Coverage and Caries (CCC) sealants evaluation system and classified into four scores: score A = sealant is present in all the fissure system; score B = sealant is present in more than 50% of the fissure system; score C = sealant is present in less than %50 of the fissure system; score D = absent sealant. 2. Dental caries evaluated using mouth mirror and blunt probe The same external examiner who was blinded to the study design did the evaluation of caries incidence and sealant retention	—

Measure

Time frame

Measured at 1, 3, 6, 12, 18 and 24 months: 1. Sealant retention evaluated according to a modified version of the Colour, Coverage and Caries (CCC) sealants evaluation system and classified into four scores: score A = sealant is present in all the fissure system; score B = sealant is present in more than 50% of the fissure system; score C = sealant is present in less than %50 of the fissure system; score D = absent sealant. 2. Dental caries evaluated using mouth mirror and blunt probe The same external examiner who was blinded to the study design did the evaluation of caries incidence and sealant retention

—

Secondary

Measure	Time frame
Presence of dental caries assessed according to ICDAS criteria at 1, 3, 6, 12, 18 and 24 months. The grades 0, 1 and 2 were recorded while scores 3, 4, 5 and 6 were recorded as one category named other grades more than grade 2. At the end of the trial, in the event of new caries development and sealant failure, the fissures were either resealed or restored.	—

Countries

Egypt

Outcome results

None listed

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