NCT07232797

Brief Summary

Abstract Background: Dental caries remains a major public health issue worldwide, particularly among children. Pit and fissure sealants represent a high-quality, evidence-based preventive measure. However, ensuring the reliability of their application by newly graduated intern dental students trained through tele-education remains an emerging area of growing interest. Objective: To evaluate the clinical success rate of pit and fissure sealants placed by intern dental students following tele-demonstration training versus traditional training approaches. Methods: This randomized controlled trial involved 100 mandibular first permanent molars in 50 children aged 7 to 9 years, treated by 20 dental interns assigned to two groups using a split-mouth design. One group received direct clinical demonstration, while the other received tele-education via a pre-recorded video. Sealant retention and marginal discoloration were assessed after a 3-month period. Keywords: tele-dentistry, tele-demonstration, tele-education, intern dental students, sealants, first permanent molar

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

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

February 25, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

September 20, 2025

Last Update Submit

November 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • sealant retention

    The retention rate of sealants was evaluated according to 'Simonsen's criteria' \[10\]: (a) Total retention - complete coverage of the occlusal surface by the sealant (score 0); (b) Partial loss - sealant present with visible fractures or partial loss of material (score 1); and (c) Total loss - complete absence of the sealant from the occlusal surface (score 2).

    3 months post application

Secondary Outcomes (1)

  • marginal discoloration

    3 months post application

Study Arms (2)

tele-demonstration group

EXPERIMENTAL

trained via pre-recorded video

Behavioral: traditional demonstration group

traditional demonstration group

ACTIVE COMPARATOR

trained via in person clinical demo

Behavioral: tele-demonstration

Interventions

tele-education via pre-recorded video tutorial for sealant application

traditional demonstration group

direct in person clinical demonstration of sealant application

tele-demonstration group

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children age extending from 7 - 9 years
  • bilaterally caries-prone, sound lower first permanent molars

You may not qualify if:

  • Teeth with initial carious lesions or cavitated lesions
  • children parents or legal guardians were unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Operative Dentistry Department, Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Ahmed El-sebaai, Lecturer

    Faculty of dentistry, Delta University, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: parallel assignment with split mouth design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

September 20, 2025

First Posted

November 18, 2025

Study Start

February 25, 2024

Primary Completion

February 27, 2025

Study Completion

April 27, 2025

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Raw data could be shared

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After publishing
Access Criteria
Principal investigator email

Locations