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Completed

NCT Number: NCT05871619

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.

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Key information

Conditions

White Spot Lesion of Tooth

Age range

15 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • - 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.

Treatment and study plan

Remin Pro

Procedure

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.

Other names: Experimental: Remin Pro with laser application, Experimental: Remin pro without laser application

X Pur Remin

Procedure

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.

Other names: Experimental: Xpur remin with laser application, Experimental: Xpur remin without laser application

Fluoride varnish

Procedure

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.

Other names: Experimental: fluoride varinsh with laser application, Experimental: fluoride varnish without laser application

Primary outcomes

  1. Spectrophotometric color assessment:

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

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

Secondary outcomes

  1. surface area measurement

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

    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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study 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

Acronym: Whitespot

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 23, 2023
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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