Dental CariesTESSNCT07232797
Sealant Application by Interns After Tele-demonstration
A study testing tele-demonstration and traditional demonstration group in people with Dental Caries and Prevention, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Prevention, Education
- What is being tested?
- tele-demonstration and traditional demonstration group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2024to 27 Apr 2025
- Phase
- Interventional
- 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children age extending from 7 - 9 years
- bilaterally caries-prone, sound lower first permanent molars
Who cannot join
- Teeth with initial carious lesions or cavitated lesions
- children parents or legal guardians were unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Operative Dentistry Department, Faculty of Dentistry
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Clinical Evaluation of Pit and Fissure Sealants Placed by Intern Dental Students After Tele-demonstration Technique
Abstract
Background:
Read more
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
Read the 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
- Conditions
- Dental Caries, Prevention, Education
- Being tested
- tele-demonstration, traditional demonstration group
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tele-demonstrationBehavioural
tele-education via pre-recorded video tutorial for sealant application
traditional demonstration groupBehavioural
direct in person clinical demonstration of sealant application
| Study group | Role | What they receive |
|---|---|---|
| tele-demonstration group | Experimental | trained via pre-recorded video Receives: Behavioral: traditional demonstration group |
| traditional demonstration group | Active comparator | trained via in person clinical demo Receives: Behavioral: tele-demonstration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months post application
Secondary outcomes (1)
marginal discoloration
Marginal discoloration was also assessed as either present or absent, as its presence may indicate early signs of marginal leakage.
Measured: 3 months post application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start25 Feb 2024
- Primary completion27 Feb 2025
- Study completion27 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment with split mouth design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed elsebaai, Mansoura University
- Investigators
- Ahmed El-sebaai, Lecturer, Principal investigator, Faculty of dentistry, Delta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232797
- Sponsor's protocol ID
- DU:0240221004
- Acronym
- TESS
- Status last verified
- Nov 2025
- First submitted
- 20 Sep 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data could be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Pit and Fissure Sealants Placed by Intern Dental Students After Tele-demonstration Technique
- ClinicalTrials.gov ID
- NCT07232797
- Acronym / sponsor ID
- TESS / DU:0240221004
- Conditions
- Dental Caries, Prevention, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Apr 2025 (actual)
- First posted
- 18 Nov 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.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel assignment with split mouth design
| Arm | Type | Receives |
|---|---|---|
| tele-demonstration group | Experimental | Behavioral: traditional demonstration grouptrained via pre-recorded video |
| traditional demonstration group | Active comparator | Behavioral: tele-demonstrationtrained via in person clinical demo |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children age extending from 7 - 9 years
- bilaterally caries-prone, sound lower first permanent molars
Key exclusion criteria (2 listed)
- Teeth with initial carious lesions or cavitated lesions
- children parents or legal guardians were unable to provide informed consent.
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 |
|---|---|---|
| tele-demonstrationtele-education via pre-recorded video tutorial for sealant application | Behavioural | traditional demonstration group |
| traditional demonstration groupdirect in person clinical demonstration of sealant application | Behavioural | tele-demonstration group |
Primary outcome
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).
1 secondary outcome
marginal discoloration
Time frame: 3 months post application
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 18 Nov 2025.
- Individual participant dataSharing planned: Yes. Raw data could be shared
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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.
Ahmed El-sebaai, Lecturer principal investigator
Faculty of dentistry, Delta University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tele-demonstration and traditional demonstration group in people with Dental Caries and Prevention, run by Mansoura University at 1 site in Egypt.
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 2 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 18 Nov 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 Egypt. 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: 3 months post application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.