NCT04929327

Brief Summary

The aim of the study is to clinically assess the effect of sandblasting prior to self-etch resin based sealant on its retention after one year follow up.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 30, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

May 30, 2021

Last Update Submit

June 16, 2021

Conditions

Caries; InitialPit and Fissure Caries

Keywords

Pit and fissure sealantSandblastingAir abrasionRetention rate

Outcome Measures

Primary Outcomes (1)

  • Retention rate

    •Full retention (FR): the material was fully present on the occlusal surfaces •Partially lost (PL): the material was present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed. •Totally lost (TL): no trace of the material was detected on the surface.

    Change from baseline at 3, 6, 12 months

Study Arms (3)

Self-etch resin based sealant

ACTIVE COMPARATOR

Self-etch resin based sealant (prevent seal) without prior sandblasting.

Procedure: Self etch Pit and fissure sealant application (prevent seal)

Prior Sandblasting

ACTIVE COMPARATOR

Self-etch resin based sealant prevent seal) with prior sandblasting.

Procedure: Self etch Pit and fissure sealant application (prevent seal) with prior sandblasting

Total-etch resin based sealant

ACTIVE COMPARATOR

Total-etch resin based sealant (ultraseal XT) (Ultradent Pro. Inc., USA)

Procedure: Total etch resin based sealant ultraseal xt

Interventions

Self etch Pit and fissure sealant application (prevent seal)PROCEDURE

Sealing deep pits and fissures

Self-etch resin based sealant
Self etch Pit and fissure sealant application (prevent seal) with prior sandblastingPROCEDURE

Sandblasting before Sealing deep pits and fissures

Prior Sandblasting
Total etch resin based sealant ultraseal xtPROCEDURE

Sealing deep pits and fissures

Total-etch resin based sealant

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
  • Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2).

You may not qualify if:

  • An individual with no previous caries experience and well coalesced pits and fissures.
  • Partially erupted teeth.
  • Teeth with cavitation or caries of the dentin.
  • Teeth with dental fluorosis, Hypocalcification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, 11331, Egypt

Location

MeSH Terms

Conditions

Van der Woude syndrome

Study Officials

  • Rawda Hesham H. Abd ElAziz, Post Phd

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Rawda Hesham H Abd ElAziz, Post Phd

CONTACT

01001097200rawda.hesham@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Degree Student- Faculty of Dentistry

Study Record Dates

First Submitted

May 30, 2021

First Posted

June 18, 2021

Study Start

July 1, 2021

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

EG(1)