Dentist's RolePhase 2NCT06119126
Two Preventive Measures on Caries Progression in Mixed Dentition Patients.
A Phase 2 study testing SDF1, Diode Laser and Pit Fissure Sealant in people with Dentist's Role, run by British University In Egypt at 1 site in Egypt.
Trial summary
Primary Objective: Assessing the clinical effect of SDF and Laser on the prevention of initial caries progression with and without pits and fissure sealants in both permanent and primary molars. Secondary Objective: Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentist's Role
- What is being tested?
- SDF1, Diode Laser and Pit Fissure Sealant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 1 Oct 2023
- Phase
- Phase 2
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- .Children aged 6-9 years old.
- .Patients categorized as moderate to high caries risk (deft index >1) showing more than 1 new carious lesions or restorations in the last 36 months according to "ADA Caries Risk Assessment Form (Age >6)" .A split mouth study design was followed where all four second molars were selected for intervention in the primary molar group, while all first molars were selected for intervention in the permanent molar group.
- .The four molars selected in each patient (primary / permanent) should be fully erupted with no gingival overhangs /operculum and with no history of previous restorations or prior sealants.
- .According to International Caries Detection and Assessment System ICDAS grading, molars with (0, 1, 2) scores only were included.
Who cannot join
- .Uncooperative or mentally challenged patients, with bad oral hygiene or rampant caries.
- .Patients providing history of bruxism or clenching affecting the posterior occlusion were excluded.
- .Children with known allergies or sensitivities to resins or silver products. .Molars that showed well-coalesced, self-cleansing pits \& fissures or shallow grooves and severe forms of hypoplasia / fluorosis were excluded.
- .Patients \& parents with high esthetic demands and concerns. .Unmotivated patients, or parents who refused to sign the consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of SDF and Laser in Preventing Initial Caries Progression With and Without Fissure Sealants in Primary and Permanent Molars
Primary Objective:
Assessing the clinical effect of SDF and Laser on the prevention of initial caries progression with and without pits and fissure sealants in both permanent and primary molars.
Secondary Objective:
Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.
Read the detailed description
Primary Objective:
Assessing the clinical effect of SDF and Laser on the prevention of initial caries progression with and without pits and fissure sealants in both permanent and primary molars.
Scoring caried out by ICDAS Scoring criteria over a 1 year follow up period
Secondary Objective:
Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.
Measured by Simonson's criteria over 1 year follow up period.
- Conditions
- Dentist's Role
- Being tested
- SDF1, Diode Laser, Pit Fissure Sealant
- Keywords
- SDF, Diode Laser, Pits and fissure sealants, primary molars, permanent molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDF1Drug
Also called silver diamine fluoride
Topical SDF application
Diode LaserDevice
Also called Class 4 dental laser
Irradiating Enamel by Diode laser
Pit Fissure SealantDrug
Also called PFS
Sealing occlusal pits and fissures
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Diode laser application only Receives: Device: Diode Laser |
| Group B | Experimental | SDF application only Receives: Drug: SDF1 |
| Group C | Experimental | Diode laser application followed by pits and fissure sealant. Receives: Device: Diode Laser; Drug: Pit Fissure Sealant |
| Group D | Experimental | SDF application followed by pits and fissure sealant. Receives: Drug: SDF1; Drug: Pit Fissure Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of molars with arrested initial decay
ICDAS II Score system
Measured: 1 year follow up
Secondary outcomes (1)
Number of molars with completely retained f pits and fissure sealants
Simonsen's Criteria
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jun 2020
- Primary completion1 Jun 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentist's RoleStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam el guindy, British University In Egypt
- Investigators
- Noha Kabil, Professor, Study director, Head of DepartmentBasma Gamal, Lecturer, Study director, Faculty Council Member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119126
- Sponsor's protocol ID
- PED 20-3D
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of SDF and Laser in Preventing Initial Caries Progression With and Without Fissure Sealants in Primary and Permanent Molars
- ClinicalTrials.gov ID
- NCT06119126
- Acronym / sponsor ID
- PED 20-3D
- Conditions
- Dentist's Role
- Keywords
- SDF, Diode Laser, Pits and fissure sealants, primary molars, permanent molars
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 7 Nov 2023 (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.
Primary Objective:
Assessing the clinical effect of SDF and Laser on the prevention of initial caries progression with and without pits and fissure sealants in both permanent and primary molars.
Secondary Objective:
Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.
Detailed description
Primary Objective:
Assessing the clinical effect of SDF and Laser on the prevention of initial caries progression with and without pits and fissure sealants in both permanent and primary molars.
Scoring caried out by ICDAS Scoring criteria over a 1 year follow up period
Secondary Objective:
Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.
Measured by Simonson's criteria over 1 year follow up period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Diode LaserDiode laser application only |
| Group B | Experimental | Drug: SDF1SDF application only |
| Group C | Experimental | Device: Diode Laser, Drug: Pit Fissure SealantDiode laser application followed by pits and fissure sealant. |
| Group D | Experimental | Drug: SDF1, Drug: Pit Fissure SealantSDF application followed by pits and fissure sealant. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- .Children aged 6-9 years old.
- .Patients categorized as moderate to high caries risk (deft index >1) showing more than 1 new carious lesions or restorations in the last 36 months according to "ADA Caries Risk Assessment Form (Age >6)" .A split mouth study design was followed where all four second molars were selected for intervention in the primary molar group, while all first molars were selected for intervention in the permanent molar group.
- .The four molars selected in each patient (primary / permanent) should be fully erupted with no gingival overhangs /operculum and with no history of previous restorations or prior sealants.
- .According to International Caries Detection and Assessment System ICDAS grading, molars with (0, 1, 2) scores only were included.
Key exclusion criteria (4 listed)
- .Uncooperative or mentally challenged patients, with bad oral hygiene or rampant caries.
- .Patients providing history of bruxism or clenching affecting the posterior occlusion were excluded.
- .Children with known allergies or sensitivities to resins or silver products. .Molars that showed well-coalesced, self-cleansing pits \& fissures or shallow grooves and severe forms of hypoplasia / fluorosis were excluded.
- .Patients \& parents with high esthetic demands and concerns. .Unmotivated patients, or parents who refused to sign the consent form.
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 |
|---|---|---|
| SDF1Also: silver diamine fluorideTopical SDF application | Drug | Group B, Group D |
| Diode LaserAlso: Class 4 dental laserIrradiating Enamel by Diode laser | Device | Group A, Group C |
| Pit Fissure SealantAlso: PFSSealing occlusal pits and fissures | Drug | Group C, Group D |
Primary outcome
Number of molars with arrested initial decay
Time frame: 1 year follow up
ICDAS II Score system
1 secondary outcome
Number of molars with completely retained f pits and fissure sealants
Time frame: 1 year follow up
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 7 Nov 2023.
- Individual participant dataSharing planned: No
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.
Noha Kabil, Professor study director
Head of Department
Basma Gamal, Lecturer study director
Faculty Council Member
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SDF1, Diode Laser and Pit Fissure Sealant in people with Dentist's Role, run by British University In Egypt 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 4 inclusion and 4 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 7 Nov 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of molars with arrested initial decay (time frame: 1 year follow up). 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 7 Nov 2023.