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

NCT ID: NCT05327049

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-10-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Deep Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

no intervention

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

Group Type EXPERIMENTAL

no intervention

Intervention Type OTHER

treatment of deep carious lesions

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.

Group Type EXPERIMENTAL

diode laser

Intervention Type DEVICE

laser light for cavity disinfection

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

Group Type EXPERIMENTAL

Aloe Vera

Intervention Type DIETARY_SUPPLEMENT

herbal dietary supplement for treatment of deep carious lesions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

no intervention

treatment of deep carious lesions

Intervention Type OTHER

diode laser

laser light for cavity disinfection

Intervention Type DEVICE

Aloe Vera

herbal dietary supplement for treatment of deep carious lesions

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hayam mosad

Assistant lecturer of operative dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maha Niazy, professor

Role: STUDY_DIRECTOR

Al-Azhar University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Al-Azhar University

Naşr, Cairo Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OPEN- 108-L

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.