Home » Trials » SLCTR/2025/005
Evaluation of deproteinization on the longevity of pit and fissure sealants in healthy enamel: controlled clinical trial.
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SLCTR Registration Number
SLCTR/2025/005
Date of Registration
The date of last modification
Feb 14, 2025
Scientific Title of Trial
Evaluation of deproteinization on the longevity of pit and fissure sealants in healthy enamel: controlled clinical trial.
Public Title of Trial
Comparison of the clinical performance of two types of pit and fissure sealants with and without deproteinizer in children: A controlled clinical trial
Disease or Health Condition(s) Studied
Dental caries
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1317-5750
Any other number(s) assigned to the trial and issuing authority
ERC number is 236 / 2024
What is the research question being addressed?
What will be the effectiveness of using sodium hypochlorite as a deproteinizing agent prior to the acid etching process on the longevity of pit and fissure sealants in healthy enamel?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Data analysts, Outcome assessors
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study site - This study will be carried out in the following public elementary schools in the State of Hidalgo: "Francisco I. Madero" elementary school located in Benito Juárez Community "Francisco I. Madero" Elementary School located in San Juan Tilcuautla "Margarita Maza de Juárez" elementary school located in the town of El Durazno "Josefa Ortiz de Dominguez" elementary school located in the town of Tlapacoya
Informed consent will be obtained from school authorities and children's guardians to participate in the study
Randomization Once the participants have been identified, a randomization will be carried out with the help of the random number function of the Microsoft ® Excel software to determine Group 1 and Group 2
Intervention
During the intervention, a Randomized Experimental Split Mouth Design will be carried out in which Group 1 and Group 2 will divide the oral cavity into upper and lower Left Side (A) and upper and lower Left Side (B)
Once the corresponding group has been assigned, the patient will be explained what the treatment consists of.
In Group 1, Ivoclar's Helioseal Clear pit and fissure sealant will be applied
Procedure for Group 1 Side A: - Wash the tooth surface with an abrasive paste. - Isolate the surface. - Application of the deproteinizing agent Sodium Hypochlorite (NaOCI) at 5.2% for 60 seconds. - Etched with 32% phosphoric acid for 15 seconds. - Wash the dental surface with plenty of water for 20 seconds. - Drying of the dental surface. - Application of pit and fissure sealant. - Sealant photopolymerization
Procedure for Side B: - Washing the tooth surface with an abrasive paste - Isolated from the Surface - Etched with 32% phosphoric acid for 15 seconds - Drying of the tooth Surface - Application of Pit and Fissure Sealant - Sealant Photopolymerization
In Group 2, the UltraSeal XT Hydro Ultradent hydrophilic pit and fissure sealant will be applied
Procedure for Side A: - Washing the tooth surface with an abrasive paste - Isolated from the Surface - Application of the deproteinizing agent Sodium Hypochlorite (NaOCI) 5.2% for 60 seconds - Etched with 32% phosphoric acid for 15 seconds - Washing the tooth surface with plenty of water for 20 seconds - Drying of the tooth Surface - Application of Pit and Fissure Sealant - Sealant Photopolymerization
Procedure for Side B: - Washing the tooth surface with an abrasive paste - Isolated from the Surface - Etched with 32% phosphoric acid for 15 seconds - Drying of the tooth Surface - Application of Pit and Fissure Sealant - Sealant Photopolymerization
The visits will be made at 3, 6, 9 and 12 months to observe each of the pit and fissure sealants, where the observations will be recorded.
The application of pit and fissure sealants will be carried out in the clinics of the academic area of Dentistry, located in the Institute of Health Sciences.
Inclusion criteria
• Children who belong to the selected population • That they are in an age range of between six and twelve years • Have the first four permanent molars healthy and fully erupted • Have your parent or guardian sign the informed consent • Boys and girls
Exclusion criteria
• Children with fixed appliances • Children with any systemic disease
Primary outcome(s)
|
1.
The retention rate of pit and fissure sealants in permanent first molars using a visual analog scale. |
[ 3, 6, 9 and 12 months after placement of the dental sealant ] |
Secondary outcome(s)
|
1.
The status of the restoration after the procedure in both groups using the Veneres evaluation criteria. (Gresnigt MM, Kalk W, Ozcan M. Randomized clinical trial of indirect resin composite and ceramic veneers: up to 3-year follow-up. J Adhes Dent. 2013 Apr;15(2):181-90. doi: 10.3290/j.jad.a28883. PMID: 23534025) |
[ 3, 6, 9 and 12 months after placement of the dental sealant ] |
Target number/sample size
66 (33 in each group)
Countries of recruitment
Mexico
Anticipated start date
2025-05-05
Anticipated end date
2027-01-10
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Nione (Investigator funded)
Regulatory approvals
Not Applicable
Status
Approved
Date of Approval
2024-02-26
Approval number
236/2024
Details of Ethics Review Committee
| Name: | ICSa-UAEH Ethics and Research Committee |
| Institutional Address: | Circuito ex-Hacienda La Concepción s/n Carretera Pachuca Actopan, San Agustin Tlaxiaca, Hidalgo. C.P. 42160 |
| Telephone: | +52 (771) 71 720 00 Ext. 4306 |
| Email: | investigacion_icsa@uaeh.edu.mx |
Contact person for Scientific Queries/Principal Investigator
Masiel Monserrat Quintana Sánchez
Master's student
Circuito ex-Hacienda La Concepción s/n Carretera Pachuca Actopan, San Agustin Tlaxiaca, Hidalgo. C.P. 42160
+52 (771) 71 720 00 Ext. 4306
massiel_quintana@outlook.com
Contact Person for Public Queries
Miguel Angel Fernandez Barrera
Associate Professor
Circuito ex-Hacienda La Concepción s/n Carretera Pachuca Actopan, San Agustin Tlaxiaca, Hidalgo. C.P. 42160
+52 (771) 71 720 00 Ext. 4306
miguel_fernandez10334@uaeh.edu.mx
Primary study sponsor/organization
Masiel Monserrat Quintana Sánchez
Master's student
Circuito ex-Hacienda La Concepción s/n Carretera Pachuca Actopan, San Agustin Tlaxiaca, Hidalgo. C.P. 42160
+52 (771) 71 720 00 Ext. 4306
massiel_quintana@outlook.com
Secondary study sponsor (If any)
Miguel Angel Fernandez Barrera
Associate Professor
Circuito ex-Hacienda La Concepción s/n Carretera Pachuca Actopan, San Agustin Tlaxiaca, Hidalgo. C.P. 42160
+52 (771) 71 720 00 Ext. 4306
miguel_fernandez10334@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 will be available. Data will be available on request from the authors Data in a particular field will be available. Analyses available on request from the authors.
Study protocol available
Yes
Protocol version and date
Not Available
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
