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

White Spot Lesion of Tooth Clinical Trial

— Whitespot  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05871619
• Other study ID #: P-OP-19-05
• Status: Completed
• Phase: N/A
• Start date: May 5, 2022
• Est. completion date: April 20, 2023

Study information

• Verified date: May 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 20, 2023
• Est. primary completion date: June 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exanthema
• White Spot Lesion of Tooth

Intervention

Procedure:
• Remin Pro
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 Remin
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 varnish
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.

Locations

Country	Name	City	State
Egypt	Al-Azhar University	El Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spectrophotometric color assessment:	The Vita Easy shade spectrophotometer (Vita Zahnfabrik, Bad Säckingen, Germany) was employed for the color assessment WSLs	from base line (application of materials) to one month
Secondary	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.	from base line (application of materials) to one month