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This clinical study is planned to be conducted to compare retention rates of pits and fissure sealants on non carious (ICDAS score 0) vs Initial carious enamel lesions (ICDAS Score 1,2) in posterior permeant teeth at 3 months, 6 months and 12 months follow-up. This will help us guide follow-up strategies for optimal caries prevention.
It is an observational, non randomized quasi experimental study design in which patients aged between 7 to 18years will be selected for the study. After obtaining informed consent, the 1st permanent molars and 2nd permanent molar (if erupted) will be evaluated for carious ICDAS SCORE. On the basis of score, the participants will be divided into two groups i.e. non carious group and initial carious group. sample size of 210 teeth will be allocated in each group. Irrespective of the carious status either non carious or initial caries enamel lesions, tooth surfaces will be etched with 37% phosphoric acid (total etch Ivoclar Vivadent) for 15 seconds till frosty white appearance is achieved. the molars will then be sealed by Conseal F sealant and light cured for 20 seconds. The patients will then be called on follow-up at 3, 6 and 12 months and retention of the sealants will be checked using Simonson criteria with the help of explorer. Simonson score I - Completely retained sealants, score II- partially retained sealants , score III complete loss of sealants. All this information will be added in the clinical Performa. After this data collection , data will be analyzed using SPSS 26.0. to compare the proportion of sealants that were lost will be compared using chi square test and p value of 0.05 will be considered significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: pit and fissure sealant non carious enamel lesions (ICDAS score 0) | pits and fissure sealants will be applied in non carious (sound) enamel surfaces of posterior permanent teeth and the retention will the evaluated at 3, 6 , and 12 months. | ||
| Group 2: pit and fissure sealant on Initial caries enamel lesions (ICDAS I and II) | pits and fissure sealants will be applied in initial carious enamel surfaces of posterior permanent teeth and the retention will the evaluated at 3, 6 , and 12 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| retention of pit and fissure sealant on non carious vs initial carious enamel lesions- 12 months follow-up study. | retention of pit and fissure sealants will be accessed through simonsen's criteria on non carious (210 teeth) vs initial carious enamel (210 teeth) with 12 month follow-up to guide follow-up strategies. | from January 2026 to June 2027 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients reporting to Paedodontics and Operative dentistry department of FUCD&H will be selected according to inclusion criteria after history, clinical examination.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shoaib Rahim, FCPS | Contact | 923215097582 | clinicaltrials.fucd@fui.edu.pk | |
| Dr. Fizza Sherazi, BDS | Contact | 923242169131 | fizzasherazi1998@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Fizza Sherazi, BDS | Foundation University Islamabad | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation University Islamabad | Recruiting | Islamabad | Federal | 44000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40417445 | Background | Nair SM, Nene KS, Tirupathi S, Mathur AA, Khan HA, Godbole NM, Patil PP, Deolikar SA. Effect of Enamel Deproteinization Prior to Etching on the Clinical Performance of Resin-based Pit and Fissure Sealants: A Split-mouth Double-blinded Pilot Randomized Controlled Trial. Int J Clin Pediatr Dent. 2025 Feb;18(2):119-125. doi: 10.5005/jp-journals-10005-3051. Epub 2025 Mar 20. | |
| 39672849 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| literature review | View IPD |
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| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| D003744 | Dental Enamel Hypoplasia |
| C536528 | Van der Woude syndrome |
| ID | Term |
|---|---|
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D009057 | Stomatognathic Diseases |
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| Background |
| McKenna G. A clinical guide to advanced minimum intervention restorative dentistry (1st ed). Br Dent J. 2024 Dec;237(11):834. doi: 10.1038/s41415-024-8183-0. No abstract available. |
| Background | Demineralization and remineralization dynamics and dental caries. |
| Background | Evaluating the effectiveness of dental sealants in caries prevention and tooth protection |
| 33037372 | Background | Banerjee A, Splieth C, Breschi L, Fontana M, Paris S, Burrow M, Crombie F, Foster Page L, Gaton-Hernandez P, Giacaman RA, Gugnani N, Hickel R, A Jordan R, Leal S, Lo E, Tassery H, Thomson WM, Manton DJ, Schwendicke F. When to intervene in the caries process? A Delphi consensus statement. Br Dent J. 2020 Oct;229(7):474-482. doi: 10.1038/s41415-020-2220-4. |
| Background | Microscopic evaluation of fissure patterns of posterior permanent teeth: An in vitro study |
| Background | Pit and Fissure Sealants as a Viable Preventive Tool for Dental Caries |
| 36141263 | Background | Beresescu L, Pacurar M, Bica CI, Vlasa A, Stoica OE, Dako T, Petcu B, Esian D. The Assessment of Sealants' Effectiveness in Arresting Non-Cavitated Caries Lesion-A 24-Month Follow-Up. Healthcare (Basel). 2022 Aug 30;10(9):1651. doi: 10.3390/healthcare10091651. |
| 39543891 | Background | Carrillo Ortiz AE, Olvera Fuentes CA, Garcia Perez A, Rodriguez Chavez JA, Villanueva Gutierrez T, Flores Ruiz HM, Mora Navarrete KA. Prevalence and severity of dental caries using ICDAS in predicting treatment needs in Mexican school-age children. J Clin Pediatr Dent. 2024 Nov;48(6):144-151. doi: 10.22514/jocpd.2024.134. Epub 2024 Nov 3. |
esearchgate.net/publication/377562421_Pit_and_Fissure_Sealants_as_a_Viable_Preventive_Tool_for_Dental_Caries |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |