NCT06895096

Brief Summary

Comparison of Retention of Self-etch sealants and Flowable Composite in permanent Molars.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
Last Updated

June 3, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

March 19, 2025

Last Update Submit

June 2, 2025

Conditions

Keywords

flowable compositeself-etch sealantsealant retention

Outcome Measures

Primary Outcomes (1)

  • sealant retention

    observation as to whether sealant is completely retained ,partially retained or completely lost

    from enrollment to end of treatment at 6 months

Study Arms (1)

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

Device: Pit Fissure Sealant

Interventions

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.

Retention of self-Etch sealants vs flowable composite in contralateral molars

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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 -

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation university college of Dentistry and Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 31710012BACKGROUND

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
06 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 26, 2025

Study Start

June 1, 2024

Primary Completion

February 28, 2025

Study Completion

March 20, 2025

Last Updated

June 3, 2025

Record last verified: 2025-06

Locations