NCT05327049

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

April 6, 2022

Last Update Submit

April 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

no intervention

EXPERIMENTAL

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

Other: no intervention

diode laser treatment

EXPERIMENTAL

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

Aloe Vera treatment

EXPERIMENTAL

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

Interventions

treatment of deep carious lesions

no intervention

laser light for cavity disinfection

diode laser treatment
Aloe VeraDIETARY_SUPPLEMENT

herbal dietary supplement for treatment of deep carious lesions

Aloe Vera treatment

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject must have active deep carious lesion.
  • clinical and radiographic examinations of carious lesions.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University

Naşr, Cairo Governorate, 11651, Egypt

Location

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Maha Niazy, professor

    Al-Azhar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of operative dentistry

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 14, 2022

Study Start

February 1, 2021

Primary Completion

October 1, 2021

Study Completion

October 11, 2021

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations