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Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant.

Primary Purpose

Dental Caries

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ethanolic extract of Aloe vera gel cavity disinfectant
Chlorohexadine
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Patients with at least two occlusal deep carious lesions, one on each side, preferred from the same arch.

    • Age range 20-50 years.
    • Systematically health.
    • Adults who were able to give informed consent.
    • Teeth with radiographic evidence of carious lesion that penetrated at least the inner one half of the dentin thickness.

Exclusion Criteria:

  • • Patients with clinical and radiographic signs of pulpal involvement.

    • Patients unable to return for recall appointments.
    • Inability of a patient to give informed consent.
    • Teeth with clinical and radiographic sign of pulpal involvement.
    • Teeth where isolation with a rubber dam was not possible

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Aloe vera group

    Chlorohexidine group

    Arm Description

    Gel cavity disinfection

    2% cavity disinfection

    Outcomes

    Primary Outcome Measures

    Bacterial reduction
    Reduction of total bacterial count of SM and LB. IT will be measured before and after cavity disinfectant.

    Secondary Outcome Measures

    Pulp vitality
    Pulp should be vital instead of death of pulp and loose its vitality

    Full Information

    First Posted
    June 22, 2020
    Last Updated
    June 24, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04446364
    Brief Title
    Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant.
    Official Title
    Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant: A Split-mouth Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    July 1, 2021 (Anticipated)
    Study Completion Date
    September 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo 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
    This Randomized Clinical Trial will be conducted to compare the efficacy of ethanolic extract of Aloe vera versus chlorhexidine cavity disinfectant in reducing total bacterial count of Streptococcus mutans (SM) and Lactobacilli (LB).
    Detailed Description
    Dental caries remains to be a major oral health problem afflicting people, young and old, especially in developing and underdeveloped countries. Though dentistry has magically developed with newer materials and newer techniques, dental caries remains a disease of great prevalence. The prevention and control of caries necessitates the elimination of cariogenic bacteria that produce acids responsible for the decrease of pH and starting the process of demineralization. While the goal of restorative treatments for dental caries is to remove the infected dentin and fill the area with a suitable restorative material, failure to remove the infected teeth surface totally and achieve complete sterilization of the cavity can lead to microleakage, increased pulp sensitivity, pulpal infection and secondary caries that necessitate replacement of restoration. Therefore, after removal of the carious dentin it is important to eliminate any remaining bacteria that may be present on the cavity walls, in the smear layer, at the enamel-dentin junction, or in the dentinal tubules. But unfortunately, no definitive and reliable criteria are available to ensure the complete removal of carious tooth structure. Many investigations have shown the presence of bacteria in the dentin even after removal of dye-stainable dentin. Due to indiscriminate use of antimicrobials more and more pathogens are becoming resistant and posing a serious threat in rendering successful treatment of the diseases. With the rise in bacterial resistance to various synthetic antimicrobial agents, there is a considerable interest and a growing trend in the field.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Aloe vera group
    Arm Type
    Experimental
    Arm Description
    Gel cavity disinfection
    Arm Title
    Chlorohexidine group
    Arm Type
    Active Comparator
    Arm Description
    2% cavity disinfection
    Intervention Type
    Other
    Intervention Name(s)
    Ethanolic extract of Aloe vera gel cavity disinfectant
    Other Intervention Name(s)
    Aloe vera
    Intervention Description
    Application of Aloe vera gel after partial caries removal then taking dentin bacterial sample to be sure for reduction of bacterial count (streptococcus mutans and Lactobacillus) in deep cavity then add final restoration
    Intervention Type
    Other
    Intervention Name(s)
    Chlorohexadine
    Intervention Description
    2%Chlorohexadine add on deep cavity as cavity disinfection after partial caries removal. Pre and post excavation bacterial count to measure bacterial reduction then add final restoration
    Primary Outcome Measure Information:
    Title
    Bacterial reduction
    Description
    Reduction of total bacterial count of SM and LB. IT will be measured before and after cavity disinfectant.
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Pulp vitality
    Description
    Pulp should be vital instead of death of pulp and loose its vitality
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Patients with at least two occlusal deep carious lesions, one on each side, preferred from the same arch. Age range 20-50 years. Systematically health. Adults who were able to give informed consent. Teeth with radiographic evidence of carious lesion that penetrated at least the inner one half of the dentin thickness. Exclusion Criteria: • Patients with clinical and radiographic signs of pulpal involvement. Patients unable to return for recall appointments. Inability of a patient to give informed consent. Teeth with clinical and radiographic sign of pulpal involvement. Teeth where isolation with a rubber dam was not possible
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sara Ibrahim Hedia, M.D.S
    Phone
    (0020)1157371420
    Email
    sara.hedia@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rasha Raafat Hassan, Assistant Proffesor
    Phone
    (0020)1006555335
    Email
    Rasha.Raafat@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant.

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