Condition category
Oral Health
Date applied
02/04/2019
Date assigned
05/04/2019
Last edited
04/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Children are at a greater risk for the development of dental caries (tooth decay) due to their diet, their permanent teeth erupting, and deep pits and fissures in the teeth which favor retention of food debris and dental plaque. Different pit and fissure sealants are used to treat caries such as composite resin, glass ionomer and resin infiltrant. There is not enough evidence about the effectiveness of resin infiltrant as a pit and fissure sealant. No consensus exists about its common use in clinical practice. In addition, investigations of the preventive effectiveness of different commercially available sealant materials are limited. The aim of this study is to assess the effectiveness of resin infiltrant (ICON) and compare its effectiveness in prevention of pits and fissures caries with two commercially available and clinically recommended fissure sealants.

Who can participate?
School children aged 6-8 years old

What does the study involve?
Participants are randomly allocated to be treated with different pit and fissure sealant materials for prevention of pit and fissure caries in their permanent first molars. Their teeth are then assessed after 1, 3, 6, 12, 18 and 24 months.

What are the possible benefits and risks of participating?
The expected benefits are prevention of dental caries and good dental health, also this trial will improve the knowledge of children and schools about the importance of prevention of dental caries. There are no anticipated risks or side effects.

Where is the study run from?
Mansoura University (Egypt)

When is the study starting and how long is it expected to run for?
July 2016 to October 2019

Who is funding the study?
Mansoura University (Egypt)

Who is the main contact?
Dr Wahdan Mohammad Abdelghany Elkwatehy
elkwatehywahdan@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Wahdan Elkwatehy

ORCID ID

Contact details

Umm Alqura
Makkah Almukarama
Makkah Almukaramah
21955
Saudi Arabia
+966 (0)582396965
elkwatehywahdan@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

149-2015

Study information

Scientific title

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

Acronym

Fissure sealant AND caries prevention

Study hypothesis

The present clinical trial aimed to:
1. Evaluate the efficacy of resin infiltrant (Icon) in prevention of pits and fissure caries
2. Evaluate the efficacy of Icon combination with nano particle resin sealing material (Seal It) in prevention of pits and fissure caries
3. Compare the efficacy of different pit and fissure sealants modalities used for prevention of pit and fissures caries in vivo

Ethics approval

Approved 16/01/2016, institutional ethical committee, Faculty of Dentistry, Mansoura University (El-Gomhoria St., Dakahlia Governorate, 35516, Egypt; Tel: +20 (0)50 2248512; Email: boshra@mans.edu.eg), IRB number: 149-2015

Study design

Single-center randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Pit and fissure dental caries

Intervention

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 randomly classified into four groups according to treatment modalities.

Blinding: Well-trained and calibrated external examiner who was blind to study design and materials used did the clinical examination and evaluation of sealant retention. The collected data was analysed by an external statistician.

Three different pit and fissure sealant materials were used in the present trial:
1. ICONTM; 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 resin fissure sealant (ICON+ SEAL IT)

For ethical reasons, all participants with dental problems were referred for necessary treatment in the dental clinic of the Pediatric Dentistry Department, Faculty of Dentistry, Mansoura University.

Baseline scores and follow up examination of dental caries in pits and fissures of molars under study recorded according to ICDAS criteria. All materials used to seal pits and fissures with strict adherence to individual manufacturer's instructions including slow speed handpiece for cleaning of the surface with fluoride free pumice/water slurry, cotton roll isolation, etching agent and fourhanded technique application.

Intervention type

Other

Phase

Drug names

Primary outcome measure

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 outcome measures

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.

Overall trial start date

01/07/2016

Overall trial end date

01/10/2019

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

44 child (176 permanent molars)

Participant 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

Recruitment start date

25/08/2016

Recruitment end date

30/11/2016

Locations

Countries of recruitment

Egypt

Trial participating centre

Mansoura University
El-Gomhoria St. Faculty of Dentistry
El-Mansoura
35516
Saudi Arabia

Sponsor information

Organisation

Mansoura University

Sponsor details

El-Gomhoria St.
Faculty of Dentistry
El-Mansoura
35516
Egypt
+20 (0)1000993389
elkwatehywahdan@gmail.com

Sponsor type

University/education

Website

http://www.mans.edu.eg/

Funders

Funder type

University/education

Funder name

Mansoura University

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Egypt

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Wahdan Elkwatehy (elkwatehywahdan@gmail.com).

Intention to publish date

01/08/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/04/2019: Trial's existence confirmed by institutional ethical committee.