Dental CariesREEPP-WSCNCT03963791
Remineralization Effect of Eggshell Powder on Post-orthodontic White Spot Lesions Compared to CPP-ACP
A study testing Eggshell powder gel and CPP-ACP crème in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
This research is conducted to compare the remineralization efficacy of eggshell powder gel and CPP-ACP (MI paste) on post-orthodontic white spot lesions. Read more about this study
- Who is it for?
- Ages 13 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Eggshell powder gel and CPP-ACP crème
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Oct 2019to 1 Jun 2020
- 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 13 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- A patient who has just completed a comprehensive orthodontic treatment.
- Presence of at least one WSL, DIAGNOdent score (0-20).
- Age range between 13 and 35years.
Who cannot join
- Patients are unable to return for recall appointments.
- High caries risk.
- Have plaque accumulation and a periodontal problem
- In progress treatment of chronic disease.
- Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
- Presence of dentin caries, enamel hypoplasia or restorations on maxillary anterior teeth.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo univercity
Cairo, 002
Mohammad Sarhan, BDS, +201005531301, mohammad_sarhan@dentistry.cu.edu.eg
About this study
Official title: Remineralization Effect of Eggshell Powder on Post-orthodontic White Spot Lesions Compared to CPP-ACP: A Randomized Controlled Clinical Trial.
This research is conducted to compare the remineralization efficacy of eggshell powder gel and CPP-ACP (MI paste) on post-orthodontic white spot lesions.
- Conditions
- Dental Caries
- Being tested
- Eggshell powder gel, CPP-ACP crème
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eggshell powder gelOther
Also called Natural product
Eggshell powder gel produced from chicken eggs.
CPP-ACP crèmeOther
Also called MI Paste
A water-based, sugar-free topical cream containing Recaladent (CCP-ACP) which is derived from the milk protein.
| Study group | Role | What they receive |
|---|---|---|
| Eggshell powder gel | Experimental | prepared from eggshell powder. applied on the tooth surfaces twice daily (after breakfast and before bedtime) after brushing the teeth. Receives: Other: Eggshell powder gel; Other: CPP-ACP crème |
| CPP-ACP crème | Active comparator | CPP-ACP crème (GC Tooth Mousse). applied on the tooth surfaces twice daily (after breakfast and before bedtime) after brushing the teeth. Receives: Other: Eggshell powder gel; Other: CPP-ACP crème |
What is being measured
The primary outcome is the main question the study is designed to answer.
white spot lesion progression.
The change in the lesion fluorescence will be evaluated using diode laser fluorescence device (Diagnodent).
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start5 Oct 2019 (estimated)
- Primary completion5 Apr 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad A Sarhan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963791
- Sponsor's protocol ID
- Oper_607
- Acronym
- REEPP-WSC
- Status last verified
- May 2019
- First submitted
- 15 May 2019
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remineralization Effect of Eggshell Powder on Post-orthodontic White Spot Lesions Compared to CPP-ACP: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03963791
- Acronym / sponsor ID
- REEPP-WSC / Oper_607
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Oct 2019 (estimated)
- Primary completion
- 5 Apr 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 28 May 2019 (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 research is conducted to compare the remineralization efficacy of eggshell powder gel and CPP-ACP (MI paste) on post-orthodontic white spot lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eggshell powder gel | Experimental | Other: Eggshell powder gel, Other: CPP-ACP crèmeprepared from eggshell powder. applied on the tooth surfaces twice daily (after breakfast and before bedtime) after brushing the teeth. |
| CPP-ACP crème | Active comparator | Other: Eggshell powder gel, Other: CPP-ACP crèmeCPP-ACP crème (GC Tooth Mousse). applied on the tooth surfaces twice daily (after breakfast and before bedtime) after brushing the teeth. |
Who may qualify
- Ages
- 13 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- A patient who has just completed a comprehensive orthodontic treatment.
- Presence of at least one WSL, DIAGNOdent score (0-20).
- Age range between 13 and 35years.
Key exclusion criteria (6 listed)
- Patients are unable to return for recall appointments.
- High caries risk.
- Have plaque accumulation and a periodontal problem
- In progress treatment of chronic disease.
- Presence of abnormal oral, medical, or mental condition (including any milk-related allergies or any medical condition involving kidneys or salivary glands).
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 |
|---|---|---|
| Eggshell powder gelAlso: Natural productEggshell powder gel produced from chicken eggs. | Other | CPP-ACP crème, Eggshell powder gel |
| CPP-ACP crèmeAlso: MI PasteA water-based, sugar-free topical cream containing Recaladent (CCP-ACP) which is derived from the milk protein. | Other | CPP-ACP crème, Eggshell powder gel |
Primary outcome
white spot lesion progression.
Time frame: 6 months.
The change in the lesion fluorescence will be evaluated using diode laser fluorescence device (Diagnodent).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eggshell powder gel and CPP-ACP crème in people with Dental Caries, 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 3 inclusion and 6 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 28 May 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
white spot lesion progression. (time frame: 6 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 28 May 2019.