Pits and Fissures SealantNCT06895096
Comparison of Retention of Self-etch Sealants and Flowable Composite in Permanent Molars
An observational study of Pits and Fissures Sealant, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Comparison of Retention of Self-etch sealants and Flowable Composite in permanent Molars. Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pits and Fissures Sealant
- What is being tested?
- Pit Fissure Sealant
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2024to 20 Mar 2025
- How long will I take part?
- 06 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 8 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 \& radiographic evaluation.
Who may be able to join
- Patients aged between 8 to 18 years.
- Patients with completely erupted maxillary and mandibular molars with deep pits and fissures having a score of 0 or 1 according to ICDAS classification -
Who cannot join
- Patients with a history of any medical conditions such as Sjogren's syndrome , renal failure or have immunocompromised state (juvenile diabetes).
- Patients with history of prolonged medication such as steroids, chemotherapy or TB medication.
- Teeth with carious lesion extending to dentino-enamel junction/dentin.
- Patients with poor oral hygiene.
- Patients with bruxism or parafunctional habits.
- Permanent molars with developmental defects or restorations.
- Teeth with poor prognosis and having periodontal diseases.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation university college of Dentistry and Hospital
Rawalpindi, Punjab Province, 46000
About this study
Comparison of Retention of Self-etch sealants and Flowable Composite in permanent Molars.
- Conditions
- Pits and Fissures Sealant
- Being tested
- Pit Fissure Sealant
- Keywords
- flowable composite, self-etch sealant, sealant retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pit Fissure SealantDevice
Flowable composite is being used for the purpose of sealing pits and fissures which require etching and bonding before application whereas self etch sealants are self adhesive and do not require etching and sealing.
| Study group | Role | What they receive |
|---|---|---|
| Retention of self-Etch sealants vs flowable composite in contralateral molars | Comparison of retention of self-etch sealants and flowable composite in inter-arch contralateral molars Receives: Device: Pit Fissure Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
sealant retention
observation as to whether sealant is completely retained ,partially retained or completely lost
Measured: from enrollment to end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Jun 2024
- Primary completion28 Feb 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pits and Fissures SealantStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 06 Months
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoaib Rahim, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895096
- Sponsor's protocol ID
- FUCDCLINIC-2407
- Status last verified
- Jun 2025
- First submitted
- 19 Mar 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Singh C, Kaur K, Kapoor K. Retention of pit and fissure sealant versus flowable composite: An in vivo one-year comparative evaluation. J Indian Soc Pedod Prev Dent. 2019 Oct-Dec;37(4):372-377. doi: 10.4103/JISPPD.JISPPD_122_19.
PubMed 31710012
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Retention of Self-etch Sealants and Flowable Composite in Permanent Molars
- ClinicalTrials.gov ID
- NCT06895096
- Acronym / sponsor ID
- FUCDCLINIC-2407
- Conditions
- Pits and Fissures Sealant
- Keywords
- flowable composite, self-etch sealant, sealant retention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 26 Mar 2025 (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.
Comparison of Retention of Self-etch sealants and Flowable Composite in permanent Molars.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 06 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retention of self-Etch sealants vs flowable composite in contralateral molars | – | Device: Pit Fissure SealantComparison of retention of self-etch sealants and flowable composite in inter-arch contralateral molars |
Who may qualify
- Ages
- 8 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 \& radiographic evaluation.
Key inclusion criteria (2 listed)
- Patients aged between 8 to 18 years.
- Patients with completely erupted maxillary and mandibular molars with deep pits and fissures having a score of 0 or 1 according to ICDAS classification -
Key exclusion criteria (7 listed)
- Patients with a history of any medical conditions such as Sjogren's syndrome , renal failure or have immunocompromised state (juvenile diabetes).
- Patients with history of prolonged medication such as steroids, chemotherapy or TB medication.
- Teeth with carious lesion extending to dentino-enamel junction/dentin.
- Patients with poor oral hygiene.
- Patients with bruxism or parafunctional habits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pit Fissure SealantFlowable composite is being used for the purpose of sealing pits and fissures which require etching and bonding before application whereas self etch sealants are self adhesive and do not require etching and sealing. | Device | Retention of self-Etch sealants vs flowable composite in contralateral molars |
Primary outcome
sealant retention
Time frame: from enrollment to end of treatment at 6 months
observation as to whether sealant is completely retained ,partially retained or completely lost
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Background: PubMed 31710012Singh C, Kaur K, Kapoor K. Retention of pit and fissure sealant versus flowable composite: An in vivo one-year comparative evaluation. J Indian Soc Pedod Prev Dent. 2019 Oct-Dec;37(4):372-377. doi: 10.4103/JISPPD.JISPPD_122_19.
- Retention of pit and fissure sealant versus flowable composite: An in vivo one-year comparative evaluationLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Pits and Fissures Sealant, 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 2 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: finished, as of the sponsor's last update on 3 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sealant retention (time frame: from enrollment to end of treatment at 6 months). 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 NCT06895096, which also lists 1 linked publication.
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 3 Jun 2025.