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
About this trial
This is an interventional treatment trial for Dental Caries
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
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
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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