Caries,DentalPhase 2/3NCT04422860
Remineralization Efficacy of Gum Arabic Varnish.
A Phase 2/3 study testing Gum Arabic varnish, Proflourid Varnish,VOCO and MI Varnish,GC Japan Inc. in people with Caries,Dental and Remineralization, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the remineralizing capacity of Gum Arabic varnish and its implementation into clinical practice. Read more about this study
- Who is it for?
- Ages 17 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental, Remineralization, White Spot Lesion
- What is being tested?
- Gum Arabic varnish, Proflourid Varnish,VOCO and MI Varnish,GC Japan Inc.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2020to Nov 2021
- Phase
- Phase 2/3
- 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 17 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with initial carious lesions.
- Proper Oral hygiene.
Who cannot join
- Patients with a compromised medical history.
- Patients with active severe periodontal disease.
- Patients with hypoplastic or hypomineralized teeth.
Trial locations and contacts
1 site in 1 country.
Ahmed H. Samaha, BSc contact
About this study
Official title: Remineralization Efficacy of Gum Arabic Varnish Versus Fluoride Varnish and CPP-ACP With Fluoride Based Varnish on Initial Carious Lesions. a Randomized Controlled Clinical Trial.
The aim of this study is to evaluate the remineralizing capacity of Gum Arabic varnish and its implementation into clinical practice.
- Conditions
- Caries,Dental, Remineralization, White Spot Lesion
- Being tested
- Gum Arabic varnish, Proflourid Varnish,VOCO, MI Varnish,GC Japan Inc.
- Keywords
- Initial carious lesion, Gum Arabic, Remineralization power, fluoride varnish, Mi varnish, Acacia senegal
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum Arabic varnishDrug
Also called Acacia senegal
Powdered exudate from various Acacia species, especially A. senegal (Leguminosae).
Proflourid Varnish,VOCODrug
5% NaF varnish
MI Varnish,GC Japan Inc.Drug
CPP-ACP with fluoride based varnish
| Study group | Role | What they receive |
|---|---|---|
| Gum Arabic varnish | Experimental | Gum arabic (Acacia senegal) is an exudate obtained from Acacia senegal stems and roots, and other similar African Acacia species. It consists mainly of high molecular weight polysaccharides high concentrations of calcium, magnesium, and potassium salts which can potentially increase tooth remineralization. Receives: Drug: Gum Arabic varnish |
| Sodium Fluoride varnish | Active comparator | The gold standard remineralizing agent recommended by the guidelines. Receives: Drug: Proflourid Varnish,VOCO |
| 10% w/v CPP-ACP, 5% sodium fluoride varnish | Active comparator | CPP-ACP is the most studied non fluoride remineralizing agent. Receives: Drug: MI Varnish,GC Japan Inc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralization through determination of lesion progression or regression
Determination of lesion level by DIAGNOdent which provides a laser fluorescence feedback to give a numerical readout reflects the amount of demineraliztion.
Measured: Change from baseline at 3,6, 9 months
Secondary outcomes (1)
Caries lesion activity assessment
Visual (change in Surface Appearance) - tactile ( change in Tactile Feeling of the surface by an explorer)
Measured: Change from baseline at 3,6, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study startOct 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- More trials run by Cairo 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hesham samaha, Cairo University
- Investigators
- Rawda H. A.ElAziz, Post Phd, Study director, Lecturer at faculty of Dentistry- Cairo UniversityRasha R Hassan, Study chair, Assistant Professor at faculty of Dentistry- Cairo UniversityAhmed H. Samaha, BSc, Principal investigator, Master's Degree student at faculty of Dentistry- Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422860
- Sponsor's protocol ID
- CEBD-2
- Status last verified
- Jul 2020
- First submitted
- 4 Jun 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Philip N. State of the Art Enamel Remineralization Systems: The Next Frontier in Caries Management. Caries Res. 2019;53(3):284-295. doi: 10.1159/000493031. Epub 2018 Oct 8.
PubMed 30296788Onishi T, Umemura S, Yanagawa M, Matsumura M, Sasaki Y, Ogasawara T, Ooshima T. Remineralization effects of gum arabic on caries-like enamel lesions. Arch Oral Biol. 2008 Mar;53(3):257-60. doi: 10.1016/j.archoralbio.2007.10.004. Epub 2007 Nov 26.
PubMed 18036508
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remineralization Efficacy of Gum Arabic Varnish Versus Fluoride Varnish and CPP-ACP With Fluoride Based Varnish on Initial Carious Lesions. a Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04422860
- Acronym / sponsor ID
- CEBD-2
- Conditions
- Caries,Dental, Remineralization, White Spot Lesion
- Keywords
- Initial carious lesion, Gum Arabic, Remineralization power, fluoride varnish, Mi varnish, Acacia senegal
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 9 Jun 2020 (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.
The aim of this study is to evaluate the remineralizing capacity of Gum Arabic varnish and its implementation into clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gum Arabic varnish | Experimental | Drug: Gum Arabic varnishGum arabic (Acacia senegal) is an exudate obtained from Acacia senegal stems and roots, and other similar African Acacia species. It consists mainly of high molecular weight polysaccharides high concentrations of calcium, magnesium, and potassium salts which can potentially increase tooth remineralization. |
| Sodium Fluoride varnish | Active comparator | Drug: Proflourid Varnish,VOCOThe gold standard remineralizing agent recommended by the guidelines. |
| 10% w/v CPP-ACP, 5% sodium fluoride varnish | Active comparator | Drug: MI Varnish,GC Japan Inc.CPP-ACP is the most studied non fluoride remineralizing agent. |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with initial carious lesions.
- Proper Oral hygiene.
Key exclusion criteria (3 listed)
- Patients with a compromised medical history.
- Patients with active severe periodontal disease.
- Patients with hypoplastic or hypomineralized teeth.
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 |
|---|---|---|
| Gum Arabic varnishAlso: Acacia senegalPowdered exudate from various Acacia species, especially A. senegal (Leguminosae). | Drug | Gum Arabic varnish |
| Proflourid Varnish,VOCO5% NaF varnish | Drug | Sodium Fluoride varnish |
| MI Varnish,GC Japan Inc.CPP-ACP with fluoride based varnish | Drug | 10% w/v CPP-ACP, 5% sodium fluoride varnish |
Primary outcome
Remineralization through determination of lesion progression or regression
Time frame: Change from baseline at 3,6, 9 months
Determination of lesion level by DIAGNOdent which provides a laser fluorescence feedback to give a numerical readout reflects the amount of demineraliztion.
1 secondary outcome
Caries lesion activity assessment
Time frame: Change from baseline at 3,6, 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Background: PubMed 30296788Philip N. State of the Art Enamel Remineralization Systems: The Next Frontier in Caries Management. Caries Res. 2019;53(3):284-295. doi: 10.1159/000493031. Epub 2018 Oct 8.
- Background: PubMed 18036508Onishi T, Umemura S, Yanagawa M, Matsumura M, Sasaki Y, Ogasawara T, Ooshima T. Remineralization effects of gum arabic on caries-like enamel lesions. Arch Oral Biol. 2008 Mar;53(3):257-60. doi: 10.1016/j.archoralbio.2007.10.004. Epub 2007 Nov 26.
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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 H. Samaha, BSc contact
Rawda H. A.ElAziz, Post Phd study director
Lecturer at faculty of Dentistry- Cairo University
Rasha R Hassan study chair
Assistant Professor at faculty of Dentistry- Cairo University
Ahmed H. Samaha, BSc principal investigator
Master's Degree student at faculty of Dentistry- Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gum Arabic varnish, Proflourid Varnish,VOCO and MI Varnish,GC Japan Inc. in people with Caries,Dental and Remineralization, run by Cairo 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 3 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 13 Jul 2020. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Rawda H. A.ElAziz, Post Phd (00201001097200, rawda.hesham@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remineralization through determination of lesion progression or regression (time frame: Change from baseline at 3,6, 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04422860, which also lists 2 linked publications.
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 13 Jul 2020.