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

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

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.

Study Overview

• Status: Completed
• Conditions: Deep Caries
• Intervention / Treatment: Other: no intervention; Device: diode laser; Dietary supplement: Aloe Vera

Detailed 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.

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

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Naşr, Cairo, Egypt, 11651
      • Al-Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: no intervention; No Intervention: conventional selective caries removal without treatment After taking the first sample of dentin, the cavity will be restored	Other: no intervention; treatment of deep carious lesions
Experimental: diode laser treatment; After selective caries removal the cavity was irradiated in contact mode with continuous wave of radiation through a 400µm flexible fiber that was inserted inside the cavity with a spiral continuous movement clockwise from the top to the floor and anti-clockwise in the reverse direction. Irradiation time was 15 seconds and repeated three times for 15 seconds interval with contact, pulsed mode and the output power was adjusted at 1.30 Watt.	Device: diode laser; laser light for cavity disinfection
Experimental: Aloe Vera treatment; After selective caries removal the lesions were treated with aloe Vera paste which was prepared by mixing aloe Vera powder by distilled water until a thick paste is formed. the paste was applied to the prepared floor by condenser to cover the remaining carious lesion	Dietary supplement: Aloe Vera; herbal dietary supplement for treatment of deep carious lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Maha Niazy, professor, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 11, 2021

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: OPEN- 108-L

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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