White Spot Lesions [Initial Caries] on Smooth Surface of ToothPhase 1NCT05202821
Clinical Evaluation of the Efficacy of SPR-G Barrier Coat Versus Fluoride Varnish Versus MI Paste in the Treatment of Early White Spot Lesions in Pediatric Patients
A Phase 1 study testing PRG Barrier Coat, Fluoride varnish and MI paste in people with White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, run by Ain Shams University at 1 site in Egypt.
Trial summary
In-Vivo randomized clinical trial to compare between the clinical performance of fluoride varnish versus MI paste (CPP_ACP) and the PRG- Barrier coat material concerning enamel remineralization, arrest of active early lesions, resolution of inactive incipient lesions and patient satisfaction and motivation with a… Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
- What is being tested?
- PRG Barrier Coat, Fluoride varnish and MI paste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Jun 2022
- Phase
- Phase 1
- 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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 10-16 years old
- Patient is healthy and medically free.
- Moderate to high level of patient cooperation
- Compliance of the primary caregiver
- Moderate to high caries risk
- Completed or in transitional fixed orthodontic treatment
- At least 1 wsl should be present
Who cannot join
- Poor oral hygiene
- Deeply Cavitated white spot lesions
- Medically Compromised patients.
- Extremely Uncooperative patient or primary caregiver
- Generalized white spot lesions in the mouth
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Al Waili, 11566
Mohamed Zayed, Assistant Professor, +20111148002, Mradwan@dent.asu.edu.eg
Mariam Alsagheer, Master's Candidate
About this study
Official title: Clinical Evaluation of the Efficacy of SPR-G (Surface Pre-reacted Glass Ionomer) Barrier Coat Versus Fluoride Varnish Versus the MI Paste (CPP-ACP) in the Treatment of Early White Spot Lesions in Pediatric Patients
In-Vivo randomized clinical trial to compare between the clinical performance of fluoride varnish versus MI paste (CPP_ACP) and the PRG- Barrier coat material concerning enamel remineralization, arrest of active early lesions, resolution of inactive incipient lesions and patient satisfaction and motivation with a 9-months follow up using a high resolution Nikon camera with Canon 700D body. Canon EF 100mm f2.8 USM Macro Lens and Nissin MF18 ring flash Canon fit for better illumination. Also, A set of retractors and A set child occlusal mirrors with A contraster for assessment of the remineralization progress of the white spot lesion.
Read the detailed description
A total of sixty (60) patients with early white spot lesions will be randomly selected to share in this study from the out-patient clinic of pedodontics and orthodontic department, Faculty of dentistry, Ain Shams University.
An informed consent will be signed by the patients and parents before their enrollment in the current study in which the aim of the study, the methodology and possible complications will be clearly described. This research will be reviewed by the research ethics committee, Faculty of dentistry, Ain Shams University. This In-vivo study will aim to evaluate the effectiveness of the SPR-G filler material sealants when compared to the fluoride varnish and the MI paste.
Precise medical, dental and family history will be taken from all patients through a direct interview and diagnostic sheet.
Teeth will be polished using a polishing brush and paste, and dried thoroughly before being examined.
Clinical examination will be done using a dental mirror and aided by the tactile detection of a dental explorer under LED illumination to make sure that the patients fulfill the inclusion criteria, followed by radiographic examination. All examination and follow up procedures will be done by the same operator to ensure standardization.
Patient's Grouping:
Selected patients will be randomly divided into three groups:
- Group (I): patients will receive Fluoride varnish ttt.
- Group (II): patients will receive PR-G Barrier coat
- Group (III): Patients will receive MI Paste (CPP-ACP)
Patients who fail to show up at the follow up examinations will be automatically excluded from the study. Patients who are no longer willing to continue in the study will have the right to quit at any time.
Patient information will be gathered and stored in the patient examination chart of the outpatient clinic, Department of Pediatric Dentistry, faculty of Dentistry, Ain Shams University. All information will be kept as a hard copy and as an electronic one as well. Patient information will be guarded as confidential information that should never be revealed at all times. This file will remain with the investigator during the study.
Outcome measurement:
9 months' in vivo evaluation of functional \& biological aspects of the three modalities regarding retention, stability, oral hygiene and patient satisfaction.
- Being tested
- PRG Barrier Coat, Fluoride varnish, MI paste
- Keywords
- White spot lesions, Fluoride varnish, MI paste (CPP_ACP), SPRG- Barrier coat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRG Barrier CoatDrug
Also called SPRG Barrier Coat
3 arm randomized single blind clinical trial comparing 3 groups. first group will be receiving fluoride varnish, second group will be receiving PRG Barrier Coat and the third group will be receiving MI paste
Fluoride varnishDrug
Also called Cavity Shield
First group will be receiving Fluoride varnish every 3 months
MI pasteDrug
Also called RECALDENT™, (CPP-ACP)
Third group will be receiving MI paste
| Study group | Role | What they receive |
|---|---|---|
| group of 20 participants receiving fluoride varnish | Active comparator | *Group (I): patients will receive Fluoride varnish ttt. Receives: Drug: Fluoride varnish |
| group of 20 participants receiving PR-G Barrier coat | Experimental | *Group (II): patients will receive PR-G Barrier coat Receives: Drug: PRG Barrier Coat |
| group of 20 participants receiving MI Paste (CPP-ACP) | Active comparator | *Group (III): Patients will receive MI Paste (CPP-ACP) Receives: Drug: MI paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the size of the white spot lesions using photographic assessment
participants are divided into 3 groups. Each group receiving a different management approach to find out the most effective drug in reducing the size of white spot lesions. Photos are taken pre-operatively. 1 month, 3 months and 9 months
Measured: 9 months
Secondary outcomes (1)
Remineralization of the enamel surface
Using photographic assessment with the aid of a software to asses the change in the height and width (i.e surface area) of the white spot lesion
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Jan 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot Lesions [Initial Caries] on Smooth Surface of ToothStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Alsagheer, Ain Shams University
- Investigators
- Amr Abd El Aziz, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202821
- Sponsor's protocol ID
- PED 18-7M
- Status last verified
- Jan 2022
- First submitted
- 1 Mar 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Efficacy of SPR-G (Surface Pre-reacted Glass Ionomer) Barrier Coat Versus Fluoride Varnish Versus the MI Paste (CPP-ACP) in the Treatment of Early White Spot Lesions in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05202821
- Acronym / sponsor ID
- PED 18-7M
- Keywords
- White spot lesions, Fluoride varnish, MI paste (CPP_ACP), SPRG- Barrier coat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 24 Jan 2022 (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.
In-Vivo randomized clinical trial to compare between the clinical performance of fluoride varnish versus MI paste (CPP_ACP) and the PRG- Barrier coat material concerning enamel remineralization, arrest of active early lesions, resolution of inactive incipient lesions and patient satisfaction and motivation with a 9-months follow up using a high resolution Nikon camera with Canon 700D body. Canon EF 100mm f2.8 USM Macro Lens and Nissin MF18 ring flash Canon fit for better illumination. Also, A set of retractors and A set child occlusal mirrors with A contraster for assessment of the remineralization progress of the white spot lesion.
Detailed description
A total of sixty (60) patients with early white spot lesions will be randomly selected to share in this study from the out-patient clinic of pedodontics and orthodontic department, Faculty of dentistry, Ain Shams University.
An informed consent will be signed by the patients and parents before their enrollment in the current study in which the aim of the study, the methodology and possible complications will be clearly described. This research will be reviewed by the research ethics committee, Faculty of dentistry, Ain Shams University. This In-vivo study will aim to evaluate the effectiveness of the SPR-G filler material sealants when compared to the fluoride varnish and the MI paste.
Precise medical, dental and family history will be taken from all patients through a direct interview and diagnostic sheet.
Teeth will be polished using a polishing brush and paste, and dried thoroughly before being examined.
Clinical examination will be done using a dental mirror and aided by the tactile detection of a dental explorer under LED illumination to make sure that the patients fulfill the inclusion criteria, followed by radiographic examination. All examination and follow up procedures will be done by the same operator to ensure standardization.
Patient's Grouping:
Selected patients will be randomly divided into three groups:
- Group (I): patients will receive Fluoride varnish ttt.
- Group (II): patients will receive PR-G Barrier coat
- Group (III): Patients will receive MI Paste (CPP-ACP)
Patients who fail to show up at the follow up examinations will be automatically excluded from the study. Patients who are no longer willing to continue in the study will have the right to quit at any time.
Patient information will be gathered and stored in the patient examination chart of the outpatient clinic, Department of Pediatric Dentistry, faculty of Dentistry, Ain Shams University. All information will be kept as a hard copy and as an electronic one as well. Patient information will be guarded as confidential information that should never be revealed at all times. This file will remain with the investigator during the study.
Outcome measurement:
9 months' in vivo evaluation of functional \& biological aspects of the three modalities regarding retention, stability, oral hygiene and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group of 20 participants receiving fluoride varnish | Active comparator | Drug: Fluoride varnish*Group (I): patients will receive Fluoride varnish ttt. |
| group of 20 participants receiving PR-G Barrier coat | Experimental | Drug: PRG Barrier Coat*Group (II): patients will receive PR-G Barrier coat |
| group of 20 participants receiving MI Paste (CPP-ACP) | Active comparator | Drug: MI paste*Group (III): Patients will receive MI Paste (CPP-ACP) |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged 10-16 years old
- Patient is healthy and medically free.
- Moderate to high level of patient cooperation
- Compliance of the primary caregiver
- Moderate to high caries risk
Key exclusion criteria (5 listed)
- Poor oral hygiene
- Deeply Cavitated white spot lesions
- Medically Compromised patients.
- Extremely Uncooperative patient or primary caregiver
- Generalized white spot lesions in the mouth
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 |
|---|---|---|
| PRG Barrier CoatAlso: SPRG Barrier Coat3 arm randomized single blind clinical trial comparing 3 groups. first group will be receiving fluoride varnish, second group will be receiving PRG Barrier Coat and the third group will be receiving MI paste | Drug | group of 20 participants receiving PR-G Barrier coat |
| Fluoride varnishAlso: Cavity ShieldFirst group will be receiving Fluoride varnish every 3 months | Drug | group of 20 participants receiving fluoride varnish |
| MI pasteAlso: RECALDENT™, (CPP-ACP)Third group will be receiving MI paste | Drug | group of 20 participants receiving MI Paste (CPP-ACP) |
Primary outcome
Change in the size of the white spot lesions using photographic assessment
Time frame: 9 months
participants are divided into 3 groups. Each group receiving a different management approach to find out the most effective drug in reducing the size of white spot lesions. Photos are taken pre-operatively. 1 month, 3 months and 9 months
1 secondary outcome
Remineralization of the enamel surface
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: Yes
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.
Amr Abd El Aziz, Professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRG Barrier Coat, Fluoride varnish and MI paste in people with White Spot Lesions [Initial Caries] on Smooth Surface of Tooth, run by Ain Shams 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Jan 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam Elsagheer, Master's Candidate (00201096735935 ext. 002010, elsagheermariam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the size of the white spot lesions using photographic assessment (time frame: 9 months). 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 24 Jan 2022.