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

NCT ID: NCT05871619

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-05
• Study Completion Date: 2023-04-20

Brief 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.

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.

Conditions

White Spot Lesion of Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Remin Pro

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Remin Pro

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

X Pur Remin

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

X Pur Remin

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Fluoride varnish

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Fluoride varnish

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Experimental: Remin Pro with laser application; Experimental: Remin pro without laser application; Experimental: Xpur remin with laser application; Experimental: Xpur remin without laser application; Experimental: fluoride varinsh with laser application; Experimental: fluoride varnish without laser application

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Amani abdullah Omar bin shahna

operative clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wael Essam, professor

Role: STUDY_DIRECTOR

for Operative Dentistry Faculty of Dental Medicine for Girls Al-Azhar University

Locations

Al-Azhar University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

P-OP-19-05

Identifier Type: -

Identifier Source: org_study_id