Enamel CariesRCTNCT03774498
Effect of Different Over-the-counter Toothpastes on Enamel Remineralization
A study testing Sensodyne repair and protect in people with Enamel Caries, run by Cairo University.
Trial summary
This study will be conducted to compare between recent over-the-counter toothpaste (Novamin \& Fluoride) and regular over-the-counter toothpaste (Sodium Fluoride) in remineralization potential, so as to be able to know which of the toothpastes will have a better remineralization potential on demineralized enamel. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Enamel Caries
- What is being tested?
- Sensodyne repair and protect
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Apr 2019
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients having at least two permanent tooth surfaces having white spot lesions (buccal/facial aspects of incisors, canines or pre-molars).
- Subjects with orthodontic appliances.
- Systemically healthy subjects of both genders, between the ages of 18 to 45 years, who were well versed with the use of toothbrush and dentifrice for oral hygiene maintenance, will be considered for the study.
Who cannot join
- Presently on desensitizing treatment.
- Subjects with bridge work that may interfere with evaluation.
- Medical histories that may compromise study protocol.(including psychiatric and pharmaco-therapeutic problems)
- Allergies.
- Systemic conditions which are etiologic/predisposing to dentinal hypersensitivity (Enamel and dentine genetic abnormalities).
- Eating disorders.
Show all 9Show fewer
- Pregnancy or breast feeding.
- Any other pathology.
- Known history of allergies to toothpaste contents.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Different Over-the-counter Toothpastes on Enamel Remineralization: A Double Blinded Randomized Clinical Trial
This study will be conducted to compare between recent over-the-counter toothpaste (Novamin \& Fluoride) and regular over-the-counter toothpaste (Sodium Fluoride) in remineralization potential, so as to be able to know which of the toothpastes will have a better remineralization potential on demineralized enamel.
Read the detailed description
Statement of problem:
Dental caries has been recognized as a dynamic process that results from an imbalance between the physiologic demineralization and remineralization of tooth structure. It has been well established that tooth undergoes cyclic demineralization of enamel crystals with periods of remineralization resulting from re-precipitation of calcium and phosphate ions from the saliva. If the process of demineralization dominates, caries result. However, if remineralization dominates along with removal of bacterial infection, enamel integrity gets restored. This basic knowledge of carious process brings us to an understanding that by controlling the amount, pattern and rhythm of demineralization and remineralization, carious lesions can either be controlled from progressing further or can be reversed. Several decades ago it was noted that clinically detectable white-spot lesions could be hardened; various scientific methods have been advocated for arrest and the reversal of incipient caries lesion by either decreasing the solubility of the mineral present or by increasing the mineral content of the previously demineralized tooth. Since remineralization occurring naturally in oral environment is often inadequate for maintaining strong decay free enamel and dentin, the process needs to be augmented by using some external means. It has been proposed that a simultaneous supply of calcium, phosphate and fluoride ions might serve as an invaluable tool to remineralize and strengthen the tooth structure by formation of calcium fluorapatite. Fluoride as a constituent of drinking water and in the form of various topically applied products especially over-the-counter toothpastes have a long successful history of use as a caries preventive agent.
NovaMin is claimed to release calcium and phosphate ions intraorally to help the self-repair process of enamel. A silica-rich surface layer forms through poly-condensation of hydrated silica groups on which precipitation of ions happens which crystallizes over time to form a hydroxyl-carbonate apatite. Although it is used extensively as a desensitizing agent reports also claim that the chemical reactions that promote apatite formation may enhance the remineralization. But there is limited clinical research to ascertain if there is any synergistic effect on combining anti-cariogenic activity of fluoride ions with these remineralization systems.
Direct benefit of the research to the human volunteer:
- Have better remineralization for initial white spot carious lesions using recent Novamin technology.
- Gain the other advantages for Novamin technology on the gingival health as well as dental health.
- Patient will know the proper brushing technique as he would be given instructions about this during the study.
- Patient will get to know the difference in efficiency of different over-the-counter toothpastes especially those assigned in the investigator's study.
Scientific value and social Benefits:
- Determine whether the new Novamin technology results are worth and have good efficient remineralization potential or not.
- Know more conservative mean for repair of demineralized areas in teeth.
- Have proper data base about difference in over-the-counter toothpastes.
Research question:
Will recent over-the-counter toothpaste (Novamin \& Fluoride) be better than regular over-the-counter toothpaste (Sodium Fluoride) in remineralization of white spot lesions in adult patients who are having initial white spot carious lesions?
- Conditions
- Enamel Caries
- Being tested
- Sensodyne repair and protect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensodyne repair and protectDrug
Also called no other names
NovaMin \& fluoride toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Sensodyne repair and protect | Active comparator | NovaMin \& fluoride toothpaste Receives: Drug: Sensodyne repair and protect |
| Sensodyne Daily Care Toothpaste 0.315% | No intervention | Sodium fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enamel remineralization
Decalcification index: (0):No white spot ,(1):Visible white spots ,no surface interruption (mild),(2):Visible white spot with roughened surface,not require restoration (moderate),(3):Visible with surface interruption (severe), (4):Cavitation.
International Caries Detection and Assessment System:(0):Sound tooth surface: No evidence of caries after 5 sec air drying ,(1):First visual change in enamel: Opacity or white or brown discoloration visible after prolonged drying,(2):Distinct change in enamel visible when wet, must be visible when dry,(3):Localized enamel breakdown (no visual signs of dentin involvement) seen when wet and after prolonged drying,(4):Underlying dark shadow from dentine,(5):Distinct cavity with visible dentine,(6): Extensive (more than half the surface) cavity with visible dentine.
Scoring is done by photographs at the beginning and at follow-up visits with the same setting each time.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enamel CariesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Farag Abd El-Khalek kelany, Cairo University
- Investigators
- Omyma Safwat, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774498
- Sponsor's protocol ID
- CEBD-CU-2018-11-22
- Acronym
- RCT
- Status last verified
- Dec 2018
- First submitted
- 10 Dec 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Over-the-counter Toothpastes on Enamel Remineralization: A Double Blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03774498
- Acronym / sponsor ID
- RCT / CEBD-CU-2018-11-22
- Conditions
- Enamel Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 13 Dec 2018 (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.
This study will be conducted to compare between recent over-the-counter toothpaste (Novamin \& Fluoride) and regular over-the-counter toothpaste (Sodium Fluoride) in remineralization potential, so as to be able to know which of the toothpastes will have a better remineralization potential on demineralized enamel.
Detailed description
Statement of problem:
Dental caries has been recognized as a dynamic process that results from an imbalance between the physiologic demineralization and remineralization of tooth structure. It has been well established that tooth undergoes cyclic demineralization of enamel crystals with periods of remineralization resulting from re-precipitation of calcium and phosphate ions from the saliva. If the process of demineralization dominates, caries result. However, if remineralization dominates along with removal of bacterial infection, enamel integrity gets restored. This basic knowledge of carious process brings us to an understanding that by controlling the amount, pattern and rhythm of demineralization and remineralization, carious lesions can either be controlled from progressing further or can be reversed. Several decades ago it was noted that clinically detectable white-spot lesions could be hardened; various scientific methods have been advocated for arrest and the reversal of incipient caries lesion by either decreasing the solubility of the mineral present or by increasing the mineral content of the previously demineralized tooth. Since remineralization occurring naturally in oral environment is often inadequate for maintaining strong decay free enamel and dentin, the process needs to be augmented by using some external means. It has been proposed that a simultaneous supply of calcium, phosphate and fluoride ions might serve as an invaluable tool to remineralize and strengthen the tooth structure by formation of calcium fluorapatite. Fluoride as a constituent of drinking water and in the form of various topically applied products especially over-the-counter toothpastes have a long successful history of use as a caries preventive agent.
NovaMin is claimed to release calcium and phosphate ions intraorally to help the self-repair process of enamel. A silica-rich surface layer forms through poly-condensation of hydrated silica groups on which precipitation of ions happens which crystallizes over time to form a hydroxyl-carbonate apatite. Although it is used extensively as a desensitizing agent reports also claim that the chemical reactions that promote apatite formation may enhance the remineralization. But there is limited clinical research to ascertain if there is any synergistic effect on combining anti-cariogenic activity of fluoride ions with these remineralization systems.
Direct benefit of the research to the human volunteer:
- Have better remineralization for initial white spot carious lesions using recent Novamin technology.
- Gain the other advantages for Novamin technology on the gingival health as well as dental health.
- Patient will know the proper brushing technique as he would be given instructions about this during the study.
- Patient will get to know the difference in efficiency of different over-the-counter toothpastes especially those assigned in the investigator's study.
Scientific value and social Benefits:
- Determine whether the new Novamin technology results are worth and have good efficient remineralization potential or not.
- Know more conservative mean for repair of demineralized areas in teeth.
- Have proper data base about difference in over-the-counter toothpastes.
Research question:
Will recent over-the-counter toothpaste (Novamin \& Fluoride) be better than regular over-the-counter toothpaste (Sodium Fluoride) in remineralization of white spot lesions in adult patients who are having initial white spot carious lesions?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensodyne repair and protect | Active comparator | Drug: Sensodyne repair and protectNovaMin \& fluoride toothpaste |
| Sensodyne Daily Care Toothpaste 0.315% | No intervention | –Sodium fluoride toothpaste |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients having at least two permanent tooth surfaces having white spot lesions (buccal/facial aspects of incisors, canines or pre-molars).
- Subjects with orthodontic appliances.
- Systemically healthy subjects of both genders, between the ages of 18 to 45 years, who were well versed with the use of toothbrush and dentifrice for oral hygiene maintenance, will be considered for the study.
Key exclusion criteria (9 listed)
- Presently on desensitizing treatment.
- Subjects with bridge work that may interfere with evaluation.
- Medical histories that may compromise study protocol.(including psychiatric and pharmaco-therapeutic problems)
- Allergies.
- Systemic conditions which are etiologic/predisposing to dentinal hypersensitivity (Enamel and dentine genetic abnormalities).
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 |
|---|---|---|
| Sensodyne repair and protectAlso: no other namesNovaMin \& fluoride toothpaste | Drug | Sensodyne repair and protect |
Primary outcome
Enamel remineralization
Time frame: 8 weeks
Decalcification index: (0):No white spot ,(1):Visible white spots ,no surface interruption (mild),(2):Visible white spot with roughened surface,not require restoration (moderate),(3):Visible with surface interruption (severe), (4):Cavitation. International Caries Detection and Assessment System:(0):Sound tooth surface: No evidence of caries after 5 sec air drying ,(1):First visual change in enamel: Opacity or white or brown discoloration visible after prolonged drying,(2):Distinct change in enamel visible when wet, must be visible when dry,(3):Localized enamel breakdown (no visual signs of dentin involvement) seen when wet and after prolonged drying,(4):Underlying dark shadow from dentine,(5):Distinct cavity with visible dentine,(6): Extensive (more than half the surface) cavity with visible dentine. Scoring is done by photographs at the beginning and at follow-up visits with the same setting each time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Omyma Safwat, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Sensodyne repair and protect in people with Enamel Caries, run by Cairo University.
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 3 inclusion and 9 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 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed F. Abd El-Khalek, Dentist (01101000457 ext. 02, mohammed.farag@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enamel remineralization (time frame: 8 weeks). 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 13 Dec 2018.