Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant.
1 other identifier
interventional
32
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
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
First Submitted
Initial submission to the registry
June 22, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedJune 26, 2020
June 1, 2020
10 months
June 22, 2020
June 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Bacterial reduction
Reduction of total bacterial count of SM and LB. IT will be measured before and after cavity disinfectant.
one year
Secondary Outcomes (1)
Pulp vitality
one year
Study Arms (2)
Aloe vera group
EXPERIMENTALGel cavity disinfection
Chlorohexidine group
ACTIVE COMPARATOR2% cavity disinfection
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.
Study Record Dates
First Submitted
June 22, 2020
First Posted
June 24, 2020
Study Start
September 1, 2020
Primary Completion
July 1, 2021
Study Completion
September 1, 2021
Last Updated
June 26, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share