- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07232797
Sealant Application by Interns After Tele-demonstration (TESS)
Clinical Evaluation of Pit and Fissure Sealants Placed by Intern Dental Students After Tele-demonstration Technique
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Abstract
Background:
Dental caries continues to be one of the most prevalent chronic diseases worldwide, with the highest incidence occurring among school-aged children. The occlusal surfaces of permanent molars are particularly susceptible due to their deep pits and fissures, which favor plaque accumulation and limit effective cleaning. The application of pit and fissure sealants has been widely recognized as an evidence-based preventive strategy that provides a physical barrier against cariogenic challenges. The quality and longevity of sealant placement, however, largely depend on the clinician's skill and adherence to proper clinical protocols. In recent years, the integration of tele-dentistry into dental education-specifically through tele-demonstration and tele-education-has gained growing attention as a means to enhance learning accessibility, particularly during times of restricted clinical training opportunities. Nevertheless, the clinical efficacy of procedures performed by newly graduated intern dental students following such digital training remains insufficiently explored.
Objective:
This study aimed to evaluate and compare the clinical performance and success rate of pit and fissure sealants applied by intern dental students trained through a tele-demonstration video-based module versus those trained through traditional chair side (face-to-face) demonstration. The primary endpoint was sealant retention, while secondary outcomes included marginal discoloration after a 3-month follow-up period.
Methods:
A randomized controlled split-mouth clinical trial was conducted on a total of 100 mandibular first permanent molars in 50 healthy children aged 7-9 years attending the pediatric dental clinics. Twenty dental interns participated in the study and were randomly allocated into two equal groups based on the mode of training received. Group A interns received conventional in-person clinical demonstrations of the sealant application procedure by a pediatric dentistry specialist. Group B interns received remote tele-demonstration training via a standardized pre-recorded instructional video detailing each clinical step, from tooth isolation and acid etching to sealant application and curing. Clinical evaluation of sealant retention and marginal discoloration after 3 months period. Data were statistically analyzed and p value significance set at p < 0.05.
Keywords:
tele-dentistry, tele-demonstration, tele-education, dental interns, pit and fissure sealants, preventive dentistry, first permanent molar
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypt, 35516
- Operative Dentistry Department, Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children age extending from 7 - 9 years
- bilaterally caries-prone, sound lower first permanent molars
Exclusion Criteria:
- Teeth with initial carious lesions or cavitated lesions
- children parents or legal guardians were unable to provide informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: tele-demonstration group
trained via pre-recorded video
|
direct in person clinical demonstration of sealant application
|
|
Active Comparator: traditional demonstration group
trained via in person clinical demo
|
tele-education via pre-recorded video tutorial for sealant application
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sealant retention
Time Frame: 3 months post application
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
marginal discoloration
Time Frame: 3 months post application
|
Marginal discoloration was also assessed as either present or absent, as its presence may indicate early signs of marginal leakage.
|
3 months post application
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed El-sebaai, Lecturer, Faculty of dentistry, Delta University, Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DU:0240221004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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