White Spot LesionNCT05721586

Self-assembling Peptide With Sodium Fluoride in Treating White Spot Lesionss in Primary Teeth

A study testing Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR and Fluoride varnish (DURAFLOR in people with White Spot Lesion, run by Hams Hamed Abdelrahman at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 to 6 years
Conditions the study is for: White Spot Lesion
What is being tested?: Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR and Fluoride varnish (DURAFLOR
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteEgypt
Study dates: 1 Jun 2020to 30 May 2021
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 3 to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

children with high caries risk with the presence of at least one visible active WSL in primary teeth with ICDAS II score of 1, 2 or 3

Who cannot join

Children with systemic diseases
Teeth with cavitated lesion involving dentin and enamel defects

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Alexandria Faculty of Dentistry
Alexandria

Other trials in Egypt

About this study

Official title: Effectiveness of Self-assembling Peptide (p11-4) in Conjunction With Fluoride Varnish in the Management of White Spot Lesions in Primary Teeth (Randomized Controlled Clinical Trial)

Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimally invasive therapy using Self-Assembling Peptide P11-4 (CURODONTTM REPAIR) which enhances remineralization of white spot lesions (WSLs). The study aimed to assess clinically the effect of Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR) versus a 5% fluoride varnish (DURAFLOR) on remineralization of enamel White Spot Lesions in primary teeth.

Conditions: White Spot Lesion
Being tested: Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR, Fluoride varnish (DURAFLOR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOROther
The WSL was Acid etched with phosphoric acid gel 35-37% for 20 seconds, the tooth surface was rinsed with water and then dried afterwards application of CURODONTTM REPAIR
Fluoride varnish (DURAFLOROther
A very thin coat of the DURAFLOR varnish was applied by a thin brush which was then allowed to dry for 10 seconds. The varnish hardens on contact with saliva or moisture

Study groups in NCT05721586
Study group	Role	What they receive
CURODONTTM REPAIR: + Fluoride varnish (DURAFLOR)	Experimental	Not described Receives: Other: Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR
Fluoride Varnish (DURAFLOR) only	Active comparator	Not described Receives: Other: Fluoride varnish (DURAFLOR

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in DIAGNOdent readings
The measurements with the DIAGNOdent device that provides numerical values from 0 to 99
Measured: Baseline, 3 months, and 6 months

Secondary outcomes (2)

Change in ICDAS II scores
Code 0 Sound tooth surface:
Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel visible when wet, lesion must be visible when dry.
Code 3: Localized enamel breakdown because of caries with no visible dentin or underlying shadow.
Code 4: Underlying dark shadow from dentin with or without localized enamel breakdown.
Code 5: Distinct cavity with visible dentin. Code 6: Extensive distinct cavity with visible dentin. After treatment, the evaluation will be performed as follows.
Measured: Baseline, 3 months, and 6 months
Change in Nyvad scores
Code 0: Sound - Normal enamel
Code 1: Active caries (intact surface) - Surface of enamel is whitish/yellowish opaque
Code 2: Active caries (surface discontinuity)
Code 3: Active caries (cavity) - Enamel/dentin cavity easily visible with the naked eye.
Code 4: Inactive caries (intact surface) - Surface of enamel is whitish, brownish or black.
Code 5: Inactive caries (surface discontinuity) - Same criteria as score 4. Localized surface defect (microcavity) in enamel only Code 6: Inactive caries (cavity) - Enamel/dentin cavity easily visible with the naked eye; surface of cavity may be shiny and feels hard on probing with gentle pressure.
Measured: Baseline, 3 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202030 May 2021

First posted10 Feb 2023
Study start1 Jun 2020
Primary completion30 May 2021
Study completion30 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for White Spot LesionStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05721586
Sponsor's protocol ID: P11-4_2020
Status last verified: Feb 2023
First submitted: 1 Feb 2023
Last updated: 10 Feb 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
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EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.
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All White Spot Lesion trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Self-assembling Peptide (p11-4) in Conjunction With Fluoride Varnish in the Management of White Spot Lesions in Primary Teeth (Randomized Controlled Clinical Trial)
ClinicalTrials.gov ID: NCT05721586
Acronym / sponsor ID: P11-4_2020
Conditions: White Spot Lesion
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Hams Hamed AbdelrahmanUniversity, hospital or other
Study start: 1 Jun 2020 (actual)
Primary completion: 30 May 2021 (actual)
Study completion: 30 May 2021 (actual)
First posted: 10 Feb 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CURODONTTM REPAIR: + Fluoride varnish (DURAFLOR)	Experimental	Other: Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLOR
Fluoride Varnish (DURAFLOR) only	Active comparator	Other: Fluoride varnish (DURAFLOR

Who may qualify

Ages: 3 to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

children with high caries risk with the presence of at least one visible active WSL in primary teeth with ICDAS II score of 1, 2 or 3

Key exclusion criteria (2 listed)

Children with systemic diseases
Teeth with cavitated lesion involving dentin and enamel defects

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
Self Assembling Peptide P11-4 (CURODONTTM REPAIR) + Fluoride varnish (DURAFLORThe WSL was Acid etched with phosphoric acid gel 35-37% for 20 seconds, the tooth surface was rinsed with water and then dried afterwards application of CURODONTTM REPAIR	Other	CURODONTTM REPAIR: + Fluoride varnish (DURAFLOR)
Fluoride varnish (DURAFLORA very thin coat of the DURAFLOR varnish was applied by a thin brush which was then allowed to dry for 10 seconds. The varnish hardens on contact with saliva or moisture	Other	Fluoride Varnish (DURAFLOR) only

Primary outcome

Change in DIAGNOdent readings
Time frame: Baseline, 3 months, and 6 months
The measurements with the DIAGNOdent device that provides numerical values from 0 to 99

2 secondary outcomes

Change in ICDAS II scores
Time frame: Baseline, 3 months, and 6 months
Change in Nyvad scores
Time frame: Baseline, 3 months, and 6 months

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 10 Feb 2023.

Related trials for White Spot Lesion

Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Recruiting
EFFICACY OF BIOMIN FLUORIDE VERSUS SODIUM FLUORIDE VARNISHES, WITH AND WITHOUT DIODE LASER ON WHITE SPOT LESIONS REMINERALIZATION IN PRIMARY TEETH.
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Not yet recruiting
S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment
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Recruiting
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Not yet recruiting
Clinical Outcomes, Cost-Effectiveness and Patient Satisfaction of Two Resin Infiltration Systems for The Management of White Spot Lesions
White Spot Lesion of Tooth

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 2 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 10 Feb 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.

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?

Change in DIAGNOdent readings (time frame: Baseline, 3 months, and 6 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 NCT05721586.

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 10 Feb 2023.