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

NCT05871619 | Completed DMC

• 1 other identifier: P-OP-19-05
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

White Spot Lesion of Tooth

Keywords

white spot lesion, diode laser, vita easy shade V

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• surface area measurement

  from base line (application of materials) to one month

Study Arms (6)

Remin Pro with laser application

EXPERIMENTAL

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

Remin pro without laser application

EXPERIMENTAL

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

Xpur remin with laser application

EXPERIMENTAL

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

Xpur remin without laser application

EXPERIMENTAL

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

fluoride varinsh with laser application

EXPERIMENTAL

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

fluoride varnish without laser application

EXPERIMENTAL

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

Interventions

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.

Also known as: Experimental: Remin Pro with laser application, Experimental: Remin pro without laser application

Remin Pro with laser application; 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.

Also known as: Experimental: Xpur remin with laser application, Experimental: Xpur remin without laser application

Xpur remin with laser application; 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.

Also known as: Experimental: fluoride varinsh with laser application, Experimental: fluoride varnish without laser application

fluoride varinsh with laser application; fluoride varnish without laser application

Eligibility Criteria

• Age: 15 Years - 40 Years
• Gender Eligibility Details: all selected patients were females for standardized in the study
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University

Cairo, Egypt

Location

Study Officials

• Wael Essam, professor

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: To avoid bias and for proper randomization, the study will be done per patient using tossing a coin to assign the tooth to be either treated with Nano hydroxyapatite with fluoride or Nano hydroxyapatite with xylitol or sodium fluoride.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: operative clinic

Model Details: * 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

Study Record Dates

• First Submitted: May 13, 2023
• First Posted: May 23, 2023
• Study Start: May 5, 2022
• Primary Completion: June 5, 2022
• Study Completion: April 20, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

EG (1)