search
Back to results

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

Primary Purpose

White Spot Lesion of Tooth

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Remin Pro
X Pur Remin
Fluoride varnish
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for White Spot Lesion of Tooth focused on measuring white spot lesion, diode laser, vita easy shade V

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Al-Azhar University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Remin Pro with laser application

Remin pro without laser application

Xpur remin with laser application

Xpur remin without laser application

fluoride varinsh with laser application

fluoride varnish without laser application

Arm Description

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.

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

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.

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

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
May 13, 2023
Last Updated
May 23, 2023
Sponsor
Al-Azhar University
search

1. Study Identification

Unique Protocol Identification Number
NCT05871619
Brief Title
Combined Application of Diode Laser and Different Remineralizing Agents on White Spot Lesions
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
June 5, 2022 (Actual)
Study Completion Date
April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
White Spot Lesion of Tooth
Keywords
white spot lesion, diode laser, vita easy shade V

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remin Pro with laser application
Arm Type
Experimental
Arm Description
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.
Arm Title
Remin pro without laser application
Arm Type
Experimental
Arm Description
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
Arm Title
Xpur remin with laser application
Arm Type
Experimental
Arm Description
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.
Arm Title
Xpur remin without laser application
Arm Type
Experimental
Arm Description
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
Arm Title
fluoride varinsh with laser application
Arm Type
Experimental
Arm Description
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.
Arm Title
fluoride varnish without laser application
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Remin Pro
Other Intervention Name(s)
Experimental: Remin Pro with laser application, Experimental: Remin pro without laser application
Intervention Description
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
Intervention Name(s)
X Pur Remin
Other Intervention Name(s)
Experimental: Xpur remin with laser application, Experimental: Xpur remin without laser application
Intervention Description
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
Intervention Name(s)
Fluoride varnish
Other Intervention Name(s)
Experimental: fluoride varinsh with laser application, Experimental: fluoride varnish without laser application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spectrophotometric color assessment:
Description
The Vita Easy shade spectrophotometer (Vita Zahnfabrik, Bad Säckingen, Germany) was employed for the color assessment WSLs
Time Frame
from base line (application of materials) to one month
Secondary Outcome Measure Information:
Title
surface area measurement
Description
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.
Time Frame
from base line (application of materials) to one month

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
all selected patients were females for standardized in the study
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wael Essam, professor
Organizational Affiliation
for Operative Dentistry Faculty of Dental Medicine for Girls Al-Azhar University
Official's Role
Study Director
Facility Information:
Facility Name
Al-Azhar University
City
El Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs