Dental EnamelNCT07330089
Retention of Pits and Fissure Sealants on Non Carious vs Initial Carious Enamel Lesions in Posterior Teeth
An observational study of Dental Enamel and Dental Enamel Hypomineralization, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Enamel, Dental Enamel Hypomineralization, Dental Enamel Hypoplasia
- How many people
- 420 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Dec 2025to 30 Jun 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients reporting to Paedodontics and Operative dentistry department of FUCD\&H will be selected according to inclusion criteria after history, clinical examination.
Who may be able to join
- Fully erupted maxillary and mandibular 1st and 2nd molars with antagonist teeth present.
- ICDAS score 0,I,II
- Age 7 to 18 years
- Both genders included
Who cannot join
- permanent teeth requiring restorations,
- uncooperative patients
- patients unwilling for follow-ups
- molars withy antagonist teeth not present
- mentally and physically handicapped patients
- patients with parafunctional habits
- patients undergoing orthodontic treatments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University Islamabad
Islamabad, Federal, 44000
Nadia Aman, BDS, FCPS, 00923022526440, nadia.aman@fui.edu.pk
Shoaib Rahim, FCPS, 00923215097582, clinicaltrials.fucd@fui.edu.pk
About this study
Official title: Retention of Pits and Fissure Sealants on Non Carious vs Initial Carious Enamel Lesions in Posterior Teeth, a Non Randomized Clinical Study
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.
Read the detailed description
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.
- Keywords
- pit and fissure sealants, pit sealant, fissure sealant
- Medical subject headings
- Dental Enamel Hypomineralization, Dental Enamel Hypoplasia, Van der Woude syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from January 2026 to June 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start27 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dental EnamelStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoaib Rahim, Foundation University Islamabad
- Investigators
- Dr. Fizza Sherazi, BDS, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330089
- Sponsor's protocol ID
- FUCDOP2512
- Status last verified
- May 2026
- First submitted
- 27 Dec 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40417445McKenna 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.
PubMed 39672849Demineralization and remineralization dynamics and dental caries.
Evaluating the effectiveness of dental sealants in caries prevention and tooth protection
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.
PubMed 33037372Microscopic evaluation of fissure patterns of posterior permanent teeth: An in vitro study
Pit and Fissure Sealants as a Viable Preventive Tool for Dental Caries
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.
PubMed 36141263Carrillo 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.
PubMed 39543891
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention of Pits and Fissure Sealants on Non Carious vs Initial Carious Enamel Lesions in Posterior Teeth, a Non Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07330089
- Acronym / sponsor ID
- FUCDOP2512
- Keywords
- pit and fissure sealants, pit sealant, fissure sealant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 27 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients reporting to Paedodontics and Operative dentistry department of FUCD\&H will be selected according to inclusion criteria after history, clinical examination.
Key inclusion criteria (4 listed)
- Fully erupted maxillary and mandibular 1st and 2nd molars with antagonist teeth present.
- ICDAS score 0,I,II
- Age 7 to 18 years
- Both genders included
Key exclusion criteria (7 listed)
- permanent teeth requiring restorations,
- uncooperative patients
- patients unwilling for follow-ups
- molars withy antagonist teeth not present
- mentally and physically handicapped patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
retention of pit and fissure sealant on non carious vs initial carious enamel lesions- 12 months follow-up study.
Time frame: from January 2026 to June 2027
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 40417445Nair 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.
- Background: PubMed 39672849McKenna 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.
- BackgroundDemineralization and remineralization dynamics and dental caries.
- BackgroundEvaluating the effectiveness of dental sealants in caries prevention and tooth protection
- Background: PubMed 33037372Banerjee 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.
- BackgroundMicroscopic evaluation of fissure patterns of posterior permanent teeth: An in vitro study
- BackgroundPit and Fissure Sealants as a Viable Preventive Tool for Dental Caries
- Background: PubMed 36141263Beresescu 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.
- Background: PubMed 39543891Carrillo 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Fizza Sherazi, BDS principal investigator
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Enamel and Dental Enamel Hypomineralization, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Shoaib Rahim, FCPS (923215097582, clinicaltrials.fucd@fui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retention of pit and fissure sealant on non carious vs initial carious enamel lesions- 12 months follow-up study. (time frame: from January 2026 to June 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07330089, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.