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White Spot Lesion of ToothWhitespotNCT05871619

Combined Application of Diode Laser and Different Remineralizing Agents on White Spot Lesions

A study testing Remin Pro, X Pur Remin and Fluoride varnish in people with White Spot Lesion of Tooth, run by Al-Azhar University 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

Dental caries is a very common condition, and although it has become less common, it still represents a serious public health risk. Caries symptoms range from the earliest molecular alterations in the tooth's apatite crystals to an apparent white spot lesion (WSL) or eventual cavitation. Read more about this study

Who is it for?
Ages 15 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
White Spot Lesion of Tooth
What is being tested?
Remin Pro, X Pur Remin and Fluoride varnish
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteEgypt
Study dates
5 May 2022to 20 Apr 2023
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 15 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • The patients should be 13-40 years old.
  • Patients should have good oral hygiene.
  • The patients with good general health and no systemic disease.

Who cannot join

  • - Presence of enamel hypoplasia or dental fluorosis.
  • Presence of carious cavity.
  • Patients who have a significant medical history,
  • Patients who have evidence of reduced salivary flow or significant tooth wear.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Al-Azhar University

    Cairo

Other trials in Egypt

About this study

Official title: Clinical Efficacy of Combined Application of Diode Laser and Different Remineralizing Agents on Combined Application of Diode Laser and Different Remineralizing Agents on White Spot Lesions

Dental caries is a very common condition, and although it has become less common, it still represents a serious public health risk. Caries symptoms range from the earliest molecular alterations in the tooth's apatite crystals to an apparent white spot lesion (WSL) or eventual cavitation. The white spot lesion looks chalky because minerals are being lost from both the surface and the underside of the enamel. A relatively simple and noninvasive caries preventive regimen in treating white spot lesions with low-level laser irradiation, either alone or with topical fluoride treatment. This treatment results in reduced enamel solubility and dissolution.

Read the detailed description

The study was reviewed and approved by the "Ethical research committee "of the Faculty of Dental Medicine for Girls; at Al-Azhar University, Cairo, Egypt. This study was conducted on 90 teeth with white spot lesions (WSLs) detected clinically on the buccal surface of teeth. The patients with WSLs were selected randomly from the operative dentistry clinic at the Faculty of Dentistry, Girl's Branch, Al-Azhar University

After examination, the teeth will be assigned into six groups of 15 teeth with white spot lesions each according to the remineralizing material used:

  • The first group (A1B1): The teeth with WSL will be treated with nano-hydroxyapatite +fluoride with laser application.
  • The second group (A1B2): The contralateral teeth will be treated with nano-hydroxyapatite +fluoride without laser application.
  • The third group (A2B1): The teeth with WSL will be treated with nano-hydroxyapatite + xylitol with laser application.
  • The fourth group (A2B2): The contralateral teeth will be treated with nano hydroxyapatite+ xylitol without laser application.
  • The fifth group (A3B1): The teeth with WSL will be treated with 5% sodium fluoride varnish with laser application.
  • The sixth group (A3B2): The contralateral teeth will be treated with 5% sodium fluoride without laser application.
Being tested
Remin Pro, X Pur Remin, Fluoride varnish
Keywords
white spot lesion, diode laser, vita easy shade V

What participants receive

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

  • Remin ProProcedure or surgery

    Also called Experimental: Remin Pro with laser application, Experimental: Remin pro without laser application

    A photosensitizing-remineralizing agent mixture was prepared by adding pre-green dye The diode laser was irradiated immediately with 1 W, Exposure time of 10 s, 810 nm, continuous and non-contact mode.

  • X Pur ReminProcedure or surgery

    Also called Experimental: Xpur remin with laser application, Experimental: Xpur remin without laser application

    A photosensitizing-remineralizing agent mixture was prepared by adding pre-green dye The diode laser was irradiated immediately with 1 W, Exposure time of 10 s, 810 nm, continuous and non-contact mode.

  • Fluoride varnishProcedure or surgery

    Also called Experimental: fluoride varinsh with laser application, Experimental: fluoride varnish without laser application

    A photosensitizing-remineralizing agent mixture was prepared by adding pre-green dye The diode laser was irradiated immediately with 1 W, Exposure time of 10 s, 810 nm, continuous and non-contact mode.

Study groups in NCT05871619
Study groupRoleWhat they receive
Remin Pro with laser applicationExperimentalA photosensitizing-remineralizing agent mixture was prepared by adding pre-green dye (0.05ml) to 1 mg of the assigned remineralizing agents. The diode laser was irradiated immediately with Average power of 1 W, Exposure time of 10 s, diode 810 nm, continuous and non-contact mode, and Irradiation speed of 1mm/ sec.
Receives: Procedure: Remin Pro
Remin pro without laser applicationExperimentalUsed a pea-sized amount with a brush and allowed it to remain on the teeth for at least three minutes as it was recommended by the manufacturer. Instructed the patient to avoid rinsing, eating, and drinking for 30 minutes
Receives: Procedure: Remin Pro
Xpur remin with laser applicationExperimentalA photosensitizing-remineralizing agent mixture was prepared by adding pre-green dye (0.05ml) to 1 mg of the assigned remineralizing agents. The diode laser was irradiated immediately with Average power of 1 W, Exposure time of 10 s, diode 810 nm, continuous and non-contact mode, and Irradiation speed of 1mm/ sec.
Receives: Procedure: X Pur Remin
Xpur remin without laser applicationExperimentalused a thin film of toothpaste on a micro brush and then applied it on the tooth surface for three minutes 2- Do not eat, drink or rinse for 30 minutes
Receives: Procedure: X Pur Remin
fluoride varinsh with laser applicationExperimentalA photosensitizing-remineralizing agent mixture was prepared by adding pre-green dye (0.05ml) to 1 mg of the assigned remineralizing agents. The diode laser was irradiated immediately with Average power of 1 W, Exposure time of 10 s, diode 810 nm, continuous and non-contact mode, and Irradiation speed of 1mm/ sec.
Receives: Procedure: Fluoride varnish
fluoride varnish without laser applicationExperimentalUsed brush applicator to uniformly apply fluoride Varnish, covering the surface to be treated as a thin film.Instructed patient to avoid hard food, alcohol, brushing or flossing for the next 4
Receives: Procedure: Fluoride varnish

What is being measured

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

  1. Spectrophotometric color assessment:

    The Vita Easy shade spectrophotometer (Vita Zahnfabrik, Bad Säckingen, Germany) was employed for the color assessment WSLs

    Measured: from base line (application of materials) to one month

Secondary outcomes (1)

  1. surface area measurement

    after the finalization of the remineralization protocol, another radiographic examination was undertaken. Bitewing radiographs of the lesions were taken using the same X-ray unit, film holders for bite recording and vertical angulations for standardizing the geometric projection of the X-ray beam by digital subtraction radiograph.

    Measured: from base line (application of materials) to one month

Timeline

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

  1. First posted23 May 2023
  2. Study start5 May 2022
  3. Primary completion5 Jun 2022
  4. Study completion20 Apr 2023

Resources

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
Model description
* The first group (A1B1):15 teeth with WSL were treated with Remin Pro with laser application. * The second group (A1B2): The contralateral 15 teeth were treated with Remin Pro without laser application. The third group (A2B1): 15 teeth with WSL were treated with X Pur Remin with laser application. * The fourth group (A2B2): The contralateral 15 teeth will be treated with XPur Remin without laser application. * The fifth group (A3B1): 15 teeth with WSL were treated with 5% sodium fluoride varnish with laser application. * The sixth group (A3B2): The contralateral 15 teeth were treated with 5% sodium fluoride without laser application
Masking
Single blind
Who is masked
Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05871619
Sponsor's protocol ID
P-OP-19-05
Acronym
Whitespot
Status last verified
May 2023
First submitted
13 May 2023
Last updated
24 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Remin Pro, X Pur Remin and Fluoride varnish in people with White Spot Lesion of Tooth, run by Al-Azhar 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 4 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 24 May 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?

Spectrophotometric color assessment: (time frame: from base line (application of materials) to one month). 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 NCT05871619.

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 May 2023.

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