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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2026/014

Enrollment

Unknown

Registered

2026-06-14

Start date

2026-06-15

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Caries disease

Interventions

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

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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] 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] 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] 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] 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] 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 ] 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	—

Measure

Time frame

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] 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] 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] 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] 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] 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 ] 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

—

Secondary

Measure	Time frame
None [None]	—

Countries

Mexico

Contacts

Public ContactAna Josefina Monjarás Ávila

Main Researcher

ana_monjaras@uaeh.edu.mx7717172000

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026