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

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.

Study Overview

• Status: Completed
• Conditions: White Spot Lesion of Tooth
• Intervention / Treatment: Procedure: Remin Pro; Procedure: X Pur Remin; Procedure: Fluoride varnish

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Cairo, Egypt
    • Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remin Pro with laser application; A 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.	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.; Other Names: Experimental: Remin Pro with laser application; Experimental: Remin pro without laser application
Experimental: Remin pro without laser application; Used 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	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.; Other Names: Experimental: Remin Pro with laser application; Experimental: Remin pro without laser application
Experimental: Xpur remin with laser application; A 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.	Procedure: 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.; Other Names: Experimental: Xpur remin with laser application; Experimental: Xpur remin without laser application
Experimental: Xpur remin without laser application; used 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	Procedure: 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.; Other Names: Experimental: Xpur remin with laser application; Experimental: Xpur remin without laser application
Experimental: fluoride varinsh with laser application; A 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.	Procedure: 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.; Other Names: Experimental: fluoride varinsh with laser application; Experimental: fluoride varnish without laser application
Experimental: fluoride varnish without laser application; Used 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	Procedure: 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.; Other Names: Experimental: fluoride varinsh with laser application; Experimental: fluoride varnish without laser application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Wael Essam, professor, for Operative Dentistry Faculty of Dental Medicine for Girls Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Actual): June 5, 2022
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: May 13, 2023
• First Submitted That Met QC Criteria: May 13, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: white spot lesion, diode laser, vita easy shade V
• Additional Relevant MeSH Terms: Skin Diseases; Exanthema; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: P-OP-19-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No