Home » Trials » SLCTR/2026/014


Comparative clinical evaluation of sealants on microcavitated caries lesions- (Evaluación clínica comparativa de selladores sobre lesiones de caries microcavitadas)

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SLCTR Registration Number

SLCTR/2026/014


Date of Registration

14 Jun 2026

The date of last modification

Jun 14, 2026



Application Summary


Scientific Title of Trial

Comparative clinical evaluation of sealants on microcavitated caries lesions- (Evaluación clínica comparativa de selladores sobre lesiones de caries microcavitadas)


Public Title of Trial

Inhibition of long-term caries on International Caries Detection and Diagnosis System (ICDAS) 3 and 4 lesions by pit and fissure sealants in adults


Disease or Health Condition(s) Studied

Caries disease


Scientific Acronym

None


Public Acronym

None


Brief title

Evaluation of sealants on caries lesions in adults


Universal Trial Number

U1111-1320-5188


Any other number(s) assigned to the trial and issuing authority

Oficio Comiteei.icsa ICSa «265» / 2024


Trial Details


What is the research question being addressed?

What is the clinical effectiveness of pit and fissure sealants on ICDAS 3 and 4 lesions in adults in inhibiting long-term caries lesions?


Type of study

Interventional


Study design

Allocation

Non-randomized controlled trial


Masking

Single blinded : Participants


Control

Uncontrolled


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 2


Intervention(s) planned

Study setting(s) - Dental Clinic of the Institute of Health Sciences of the Autonomous University of the State of Hidalgo

Recruitment - Clinical and radiographic examination of the patient to verify caries lesions in the first or second permanent molars with ICDAS codes 3 and 4. Each patient will be informed of their participation and will be provided with a written brochure detailing the steps to follow and the reasons for discontinuing participation. A specially designed clinical history will then be taken to record personal and demographic data, as well as the patient's clinical history. A diagnosis of dental caries severity will be made based on the International Caries Detection and Diagnosis System (ICDAS). Explain the treatment application method and its benefits. Obtain patient agreement and sign the informed consent form Request follow-up sessions after 6, 12, 18, 24, 30, and 36 months for follow-up

Participation Record Each patient will be informed of their participation and will be provided with a written brochure detailing the steps to follow and the reasons for discontinuing participation. A specially designed clinical history will then be taken to record personal and demographic data, as well as the patient's clinical history. A diagnosis of dental caries severity will be made based on the International Caries Detection and Diagnosis System (ICDAS), and sealants will be placed.

Medical History The medical history is divided into four sections to obtain important patient information. 1. Identification form. This form collects the patient's personal and demographic information. Name, address and phone number, sex, date of birth, and age (Document 1. Medical History, Appendix section). 2. General medical information. This form collects a history of medical conditions, taking into account central nervous system diseases, endocrine diseases, cardiac diseases, genitourinary system diseases, infectious diseases, allergies, surgical procedures, drug treatment, previous trauma, and toxic habits (alcohol, tobacco, and drugs) (Document 1. Medical History, Appendix section), as these may determine exclusion criteria for participation in the study. 3. Dental information. An assessment of dental caries risk factors is performed, including dietary and hygiene habits, previous treatments, dental and gingival pathology, and perception of saliva quantity as well as a socioeconomic assessment to determine the patient's caries risk assessing factors that could influence the follow-up and success of sealants. 4. Clinical evaluation. An odontogram is completed to diagnose teeth with caries lesions and their severity. The dental organs with restorations and those missing are also recorded

Intervention

Sealant Application 1. Complete isolation will be performed with a rubber dam and atraumatic clamp (Soft Clamp, Kerr) for both molars to be treated. Prophylaxis will be performed on the occlusal surfaces of the molars with in two groups of patients with ICDAS 3 and 4 lesions using a low-speed handpiece with a prophylaxis brush and water, and then dried with oil-free air. 2. As a next step, the occlusal enamel will be etched with 37% orthophosphoric acid (Total Etch Ivoclar Vivadent) for 15 seconds, then rinsed with water for 30 seconds and dried with oil-free air for 10 seconds. 3. A resin-based SFF (Equia Forte Coat) will be placed and polymerized with a light-curing lamp for 20 seconds, 0.5 cm away from the tooth. 5. If any porosity is detected, additional material will be applied. 6. Postoperative instructions and dental recommendations regarding hygiene and nutrition will be provided. 7. Treatments will be performed by a single operator.

  1. Same intervention will be performed on 30 patients diagnosed with ICDAS 3 and 30 patients diagnosed with ICDAS 4

Finally, they will be given a card recording your six-monthly attendance, as well as the results of the measurements taken on the day of your appointment.


Inclusion criteria

  1. Systemically healthy adult male or female, aged 18 to 25 years.

  2. Presence of first and/or second permanent molars with ICDAS 3 and 4 caries lesions.


Exclusion criteria

The exclusion criteria will be as follows:

  1. Patients with molars that receive excessive or no load due to malocclusion.

  2. Patients undergoing orthodontic treatment.

  3. Patients with enamel defects (hypoplasia, fluorosis, hypocalcification).

  4. Patients with periodontal disease.

  5. Patients on medication (antihistamines, antidepressants, anxiolytics, and sedatives).

  6. Presence of symptoms of pulp disease in first and second molars.



Primary outcome(s)

1.

Color stability: An initial photograph will be taken with a camera in manual mode (Canon EOS Rebel T6) under natural light. The change in the SFF value will be assessed in the photograph and stability will be determined using the alpha, bravo, and Charlie criteria, based on the USPHS criteria.

[

Baseline, 6, 12, 18, 24, 30 and 36 months

]
2.

The surface texture of the newly applied SFF will be observed using a digital zoom microscope (USB Digital Microscope 1600x Optical Zoom HD 8 LEDs) with the aid of an OMS probe, to determine the alpha, bravo, and Charlie (USPHS) criteria.

[

Baseline, 6, 12, 18, 24, 30 and 36 months

]
3.

The degree of wear of the newly applied SFF will be observed using an OMS probe and refraction mirror every 6 months to verify the presence of material over the cracks, based on the alpha, bravo, and Charlie (USPHS) criteria.

[

Baseline, 6, 12, 18, 24, 30 and 36 months

]
4.

Degree of retention in molars with newly applied SFF and subsequently every 6 months, using a digital zoom microscope (1600x USB Digital Microscope Optical Zoom HD 8 LEDs) and WHO probe, based on the alpha, bravo and charlie criteria (USPHS).

[

Baseline, 6, 12, 18, 24, 30 and 36 months

]
5.

Staining of the superficial cavus margin of newly applied FPS, and every 6 months thereafter, using a digital zoom microscope (1600x USB Digital Microscope, HD Optical Zoom, 8 LEDs) and clinical photography based on the Alpha, Bravo, and Charlie criteria (USPHS)

[

Baseline, 6, 12, 18, 24, 30 and 36 months

]
6.

Marginal integrity of newly applied FPS, and every 6 months thereafter, using an explorer to verify the existence of gaps between the FPS margin and the tooth, based on the Alpha, Bravo, and Charlie criteria (USPHS).

[

Baseline, 6, 12, 18, 24, 30 and 36 months

]
7.

Presence of secondary caries in molars with newly applied PFS, and every 6 months thereafter, is confirmed by a digital zoom microscope (1600x USB Digital Microscope, HD Optical Zoom, 8 LEDs). If the lesion is present, it is assessed by bitewing radiography to verify the percentage of progression (superficial, middle, and deep dentin)

[

Baseline, 6, 12, 18, 24, 30 and 36 months

]
8.

Degree of retention in molars with newly applied SFF and subsequently every 6 months, using a digital zoom microscope (1600x USB Digital Microscope Optical Zoom HD 8 LEDs) and WHO probe, based on the alpha, bravo and charlie criteria (USPHS).

[

Baseline, 6, 12, 18, 24, 30 and 36 months

]

Secondary outcome(s)

1.

None

[

None

]

Target number/sample size

30 patients diagnosed with ICDAS 3 and 30 patients diagnosed with ICDAS 4


Countries of recruitment

Mexico


Anticipated start date

2026-06-15


Anticipated end date

2028-10-03


Date of first enrollment


Date of study completion


Recruitment status

Recruiting


Funding source

Autofinanciado


Regulatory approvals

U1111-1320-5188



State of Ethics Review Approval


Status

Approved


Date of Approval

2024-10-15


Approval number

Oficio Comiteei.icsa ICSa «265» / 2024


Details of Ethics Review Committee

Name: Autonomous University of the State of Hidalgo
Institutional Address:Pachuca-Actopan Highway, road to Tilcuautla s/n, San Juan Tilcuautla Town, 42160 Hidalgo, Mexico.
Telephone:7717172000
Email:

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Ana Josefina Monjarás Ávila
Main Researcher
Pachuca-Actopan Highway, road to Tilcuautla, s/n, San Juan Tilcuautla, 42160 Hidalgo, Mexico.
7717172000
7714900163

ana_monjaras@uaeh.edu.mx

Contact Person for Public Queries

Ana Josefina Monjarás Ávila
Main Researcher
Pachuca-Actopan Highway, road to Tilcuautla, s/n, San Juan Tilcuautla, 42160 Hidalgo, Mexico.
7717172000
7714900163

ana_monjaras@uaeh.edu.mx


Primary study sponsor/organization

Ana Josefina Monjarás Ávila
Main Researcher
Pachuca-Actopan Highway, road to Tilcuautla, s/n, San Juan Tilcuautla, 42160 Hidalgo, Mexico..
7714900163

ana_monjaras@uaeh.edu.mx

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes


IPD sharing plan description

Individual participant data that underlie the results being reported, after de-identification (text, tables, figures and appendices)


Study protocol available

Yes


Protocol version and date

Version 2.1


Protocol URL


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results