Evaluation of the Remineralizing Effect of Aloe Vera Versus Diode Laser for Management of Deep Carious Lesions.

Deep Caries Clinical Trial

Official title:

Evaluation of the Remineralizing Effect of Aloe Vera Versus Diode Laser for Management of Deep Carious Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05327049
• Other study ID #: OPEN- 108-L
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: October 11, 2021

Study information

• Verified date: April 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study will be performed to evaluate:

The remineralizing effect of Aloe Vera versus Diode laser on deep carious dentin after selective caries removal.

Description:

This study was conducted on 45 teeth selected from patients according to inclusion and exclusion criteria. They were selected from the dental clinic in faculty of oral and dental medicine for girls, Al-Azhar University. The procedure was explained and written informed consent was obtained from each patient. The possible discomforts, risks, and benefits were fully explained to the patients. Ethical committee approval was obtained.

Protocol of caries removal was Applied Subsequently, the central cariogenic biomasses and superficial part of the necrotic and demineralized dentin was excavated, leaving the leathery dentin layer.

Sample grouping:

The patients were randomly assigned into three main groups according to the material used (15 for each) which were assessed at different time intervals (B1) after three months,(B2) after six months.

A1: cavities will be sealed directly by temporary restorative material (conventional glass ionomer) without any treatment.

A2: cavities will be treated by Diode laser then sealed directly by temporary conventional glass ionomer.

A3: cavities will be treated with Aloe Vera then sealed directly by temporary conventional glass ionomer.

Evaluation of the remineralization effect of Each group will be assessed radiographically immediately at base line (B0), after three months (B1) and six months (B2) to evaluate the dentin remineralization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 11, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Subject must have active deep carious lesion.

• clinical and radiographic examinations of carious lesions.

Exclusion Criteria:

• Teeth with pulpal involvement

• Teeth with abscess

• Teeth with pain or swelling

• Teeth with developmental disorders

• Teeth with adjacent soft tissue lesions

• patients with systemic illness will be excluded

Related Conditions & MeSH terms

• Deep Caries
• Dental Caries

Intervention

Other:
• no intervention
treatment of deep carious lesions

Device:
• diode laser
laser light for cavity disinfection

Dietary Supplement:
• Aloe Vera
herbal dietary supplement for treatment of deep carious lesions

Locations

Country	Name	City	State
Egypt	Al-Azhar University	Nasr	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	assessment of the remineralizing effect of aloe vera and diode laser on deep caries	remineralisation will be assessed by radiodensity using digital radiography	6 months