Dental CariesNCT04446364
Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant.
A study testing Ethanolic extract of Aloe vera gel cavity disinfectant and Chlorohexadine in people with Dental Caries, run by Cairo University.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Ethanolic extract of Aloe vera gel cavity disinfectant and Chlorohexadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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.
Who cannot join
- • 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant: A Split-mouth Randomized Clinical Trial
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).
Read the 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.
- Conditions
- Dental Caries
- Being tested
- Ethanolic extract of Aloe vera gel cavity disinfectant, Chlorohexadine
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethanolic extract of Aloe vera gel cavity disinfectantOther
Also called Aloe vera
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
ChlorohexadineOther
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
| Study group | Role | What they receive |
|---|---|---|
| Aloe vera group | Experimental | Gel cavity disinfection Receives: Other: Ethanolic extract of Aloe vera gel cavity disinfectant; Other: Chlorohexadine |
| Chlorohexidine group | Active comparator | 2% cavity disinfection Receives: Other: Ethanolic extract of Aloe vera gel cavity disinfectant; Other: Chlorohexadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial reduction
Reduction of total bacterial count of SM and LB. IT will be measured before and after cavity disinfectant.
Measured: one year
Secondary outcomes (1)
Pulp vitality
Pulp should be vital instead of death of pulp and loose its vitality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ibrahim Ahmed Hedia, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446364
- Sponsor's protocol ID
- Ethanolic Extract of Aloe vera
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 26 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant: A Split-mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04446364
- Acronym / sponsor ID
- Ethanolic Extract of Aloe vera
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aloe vera group | Experimental | Other: Ethanolic extract of Aloe vera gel cavity disinfectant, Other: ChlorohexadineGel cavity disinfection |
| Chlorohexidine group | Active comparator | Other: Ethanolic extract of Aloe vera gel cavity disinfectant, Other: Chlorohexadine2% cavity disinfection |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Patients with at least two occlusal deep carious lesions, one on each side, preferred from the same arch.
Key exclusion criteria (5 listed)
- • Patients with clinical and radiographic signs of pulpal involvement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethanolic extract of Aloe vera gel cavity disinfectantAlso: Aloe veraApplication 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 | Other | Aloe vera group, Chlorohexidine group |
| Chlorohexadine2%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 | Other | Aloe vera group, Chlorohexidine group |
Primary outcome
Bacterial reduction
Time frame: one year
Reduction of total bacterial count of SM and LB. IT will be measured before and after cavity disinfectant.
1 secondary outcome
Pulp vitality
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Ethanolic extract of Aloe vera gel cavity disinfectant and Chlorohexadine in people with Dental Caries, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Ibrahim Hedia, M.D.S ((0020)1157371420, sara.hedia@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial reduction (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.