search
Back to results

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

Primary Purpose

Deep Caries

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
no intervention
diode laser
Aloe Vera
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Caries

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Al-Azhar University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

no intervention

diode laser treatment

Aloe Vera treatment

Arm Description

No Intervention: conventional selective caries removal without treatment After taking the first sample of dentin, the cavity will be restored

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.

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

Outcomes

Primary Outcome Measures

assessment of the remineralizing effect of aloe vera and diode laser on deep caries
remineralisation will be assessed by radiodensity using digital radiography

Secondary Outcome Measures

Full Information

First Posted
April 6, 2022
Last Updated
April 12, 2022
Sponsor
Al-Azhar University
search

1. Study Identification

Unique Protocol Identification Number
NCT05327049
Brief Title
Evaluation of the Remineralizing Effect of Aloe Vera Versus Diode Laser for Management of Deep Carious Lesions.
Official Title
Evaluation of the Remineralizing Effect of Aloe Vera Versus Diode Laser for Management of Deep Carious Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 11, 2021 (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

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Caries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no intervention
Arm Type
Experimental
Arm Description
No Intervention: conventional selective caries removal without treatment After taking the first sample of dentin, the cavity will be restored
Arm Title
diode laser treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Aloe Vera treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
no intervention
Intervention Description
treatment of deep carious lesions
Intervention Type
Device
Intervention Name(s)
diode laser
Intervention Description
laser light for cavity disinfection
Intervention Type
Dietary Supplement
Intervention Name(s)
Aloe Vera
Intervention Description
herbal dietary supplement for treatment of deep carious lesions
Primary Outcome Measure Information:
Title
assessment of the remineralizing effect of aloe vera and diode laser on deep caries
Description
remineralisation will be assessed by radiodensity using digital radiography
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maha Niazy, professor
Organizational Affiliation
Al-Azhar University
Official's Role
Study Director
Facility Information:
Facility Name
Al-Azhar University
City
Naşr
State/Province
Cairo
ZIP/Postal Code
11651
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs