Home » Trials » SLCTR/2026/014
Comparative clinical evaluation of sealants on microcavitated caries lesions- (Evaluación clínica comparativa de selladores sobre lesiones de caries microcavitadas)
-
SLCTR Registration Number
SLCTR/2026/014
Date of Registration
The date of last modification
Jun 14, 2026
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
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.
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
Systemically healthy adult male or female, aged 18 to 25 years.
Presence of first and/or second permanent molars with ICDAS 3 and 4 caries lesions.
Exclusion criteria
The exclusion criteria will be as follows:
Patients with molars that receive excessive or no load due to malocclusion.
Patients undergoing orthodontic treatment.
Patients with enamel defects (hypoplasia, fluorosis, hypocalcification).
Patients with periodontal disease.
Patients on medication (antihistamines, antidepressants, anxiolytics, and sedatives).
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
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 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
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