Caries, DentalPhase 2NCT03108313
Role of Aloe Vera Versus Fluoride Toothpaste in Changing High to Low Salivary Bacterial Count
A Phase 2 study testing aloe vera toothpaste and fluoride toothpaste in people with Caries, Dental, run by Cairo University at 1 site in Egypt.
Trial summary
Patient's salivary bacterial count will be evaluated , then the patient will bbe instructed to follow oral hygiene measures including the use of aloe vera toothpaste or fluoride toothpaste , the after 15 days and 30 days the patient's salivary bacterial count will be evaluated another time. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental
- What is being tested?
- aloe vera toothpaste and fluoride toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2017to 30 Apr 2018
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients should have poor oral hygiene.
- Patients should have high bacterial count
Who cannot join
- Patients with a compromised medical history.
- Severe or active periodontal disease .
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Neven Ahmed Ebrahim
Cairo, Heliopolis, 11311
Neven Ahmed Ebrahim, master, 01153621944, nova480@yahoo.com
Neven Ahmed Ebrahim, master, 01005475566, Dr.mohamedsabry90@yahoo.com
About this study
Official title: Role of Aloe Vera Versus Fluoride Toothpaste in Changing High to Low Salivary Bacterial Count :Randomized Controlled Trial
Patient's salivary bacterial count will be evaluated , then the patient will bbe instructed to follow oral hygiene measures including the use of aloe vera toothpaste or fluoride toothpaste , the after 15 days and 30 days the patient's salivary bacterial count will be evaluated another time.
Read the detailed description
Variables of study:
Each patient will be instructed to follow oral hygiene measures including aloe vera or fluoride toothpaste
Outcomes:
Salivary bacterial count will be evaluated using Mitis salivarius agar plates before the use of the aloe vera toothpaste then after 15 days then after 30 days .
Participant timeline:
Enrolment Baseline assessment 15 days 30 days
(1st visit ) (2nd visit) (3rd visit )
II.6.Sample size calculation :
Based on previous study , the mean percent change reduction in bacterial count was 3+4 . using power 80 % and 5 % significance level , we will need to study 29 in each group to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I probability associated with this test of this null hypothesis is 0.05.
Recruitment \& Recruitment Strategy:
Screening of patients that come to the conservative dentistry department seeking dental care will continue until the target population is achieved. The patients will be subjected to full examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research investigator who will explain the study and ascertains the patient's interest. Randomization and assignment of interventions:
Randomization will be done according to a check list including the number of participants divided into 2 groups according to interventions/Control assessment method
Allocation sequence generation:
The allocation sequence will be generated using (www.randomization.com).
Allocation concealment mechanism:
A checklist will be designed to identify each assessment method.
Implementation A participant will generate the random allocation sequence. The researcher will enroll the patients but an unbiased participant will assign the intervention/Control identification procedures to respective teeth.
Blinding:
The participants will be blinded to intervention/control assessment methods. Also, it will not be allowed amongst the examiners to exchange any information throughout the entire study period.
Data collection methods:
High caries index will be assessed 3 times , at base line , then 15 days and 30 days.
Funding:
The research will be self-funded by the researcher.
- Conditions
- Caries, Dental
- Being tested
- aloe vera toothpaste, fluoride toothpaste
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aloe vera toothpasteDrug
Also called aloe dent toothpaste, aloe dent
herbal toothpaste used to decrease salivary streptococcus bacterial count
fluoride toothpasteDrug
Also called signal toothpaste
chemical toothpaste used to decrease salivary streptococcus bacterial count
| Study group | Role | What they receive |
|---|---|---|
| aloe vera toothpaste | Experimental | aloe vera toothpaste isa will be administrated 2 times per day for 30 days and salivary bacterial count will be tested before the use of toothpaste the after 15 days and 30 days Receives: Drug: aloe vera toothpaste |
| fluoride toothpaste | Active comparator | fluoride toothpaste isa herbal toothpaste will be administrated 2 times per day for 30 days and salivary bacterial count will be tested before the use of toothpaste the after 15 days and 30 days Receives: Drug: fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary bacterial count
will be done using mitis salivarius agar plate
Measured: average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start3 Mar 2017
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caries, DentalStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neven Ahmed Ebrahim, Cairo University
- Investigators
- Amira Farid, PHD, Study director, professor at conservative department cairo universityRasha Rafaat, PHD, Study chair, lecturer at conservative department cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108313
- Sponsor's protocol ID
- CEBC-CU-2017-30-16
- Status last verified
- Jul 2017
- First submitted
- 29 Mar 2017
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: publishing the data at egyptian dental journal
Publications
Bhati N, Jaidka S, Somani R. Evaluation of antimicrobial efficacy of Aloe vera and Meswak containing dentifrices with fluoridated dentifrice: An in vivo study. J Int Soc Prev Community Dent. 2015 Sep-Oct;5(5):394-9. doi: 10.4103/2231-0762.165924.
PubMed 26539392
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Aloe Vera Versus Fluoride Toothpaste in Changing High to Low Salivary Bacterial Count :Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03108313
- Acronym / sponsor ID
- CEBC-CU-2017-30-16
- Conditions
- Caries, Dental
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 11 Apr 2017 (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.
Patient's salivary bacterial count will be evaluated , then the patient will bbe instructed to follow oral hygiene measures including the use of aloe vera toothpaste or fluoride toothpaste , the after 15 days and 30 days the patient's salivary bacterial count will be evaluated another time.
Detailed description
Variables of study:
Each patient will be instructed to follow oral hygiene measures including aloe vera or fluoride toothpaste
Outcomes:
Salivary bacterial count will be evaluated using Mitis salivarius agar plates before the use of the aloe vera toothpaste then after 15 days then after 30 days .
Participant timeline:
Enrolment Baseline assessment 15 days 30 days
(1st visit ) (2nd visit) (3rd visit )
II.6.Sample size calculation :
Based on previous study , the mean percent change reduction in bacterial count was 3+4 . using power 80 % and 5 % significance level , we will need to study 29 in each group to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. The Type I probability associated with this test of this null hypothesis is 0.05.
Recruitment \& Recruitment Strategy:
Screening of patients that come to the conservative dentistry department seeking dental care will continue until the target population is achieved. The patients will be subjected to full examination and diagnosis using dental charts. Once the patients that are potentially eligible for this study are identified, they will be contacted by the research investigator who will explain the study and ascertains the patient's interest. Randomization and assignment of interventions:
Randomization will be done according to a check list including the number of participants divided into 2 groups according to interventions/Control assessment method
Allocation sequence generation:
The allocation sequence will be generated using (www.randomization.com).
Allocation concealment mechanism:
A checklist will be designed to identify each assessment method.
Implementation A participant will generate the random allocation sequence. The researcher will enroll the patients but an unbiased participant will assign the intervention/Control identification procedures to respective teeth.
Blinding:
The participants will be blinded to intervention/control assessment methods. Also, it will not be allowed amongst the examiners to exchange any information throughout the entire study period.
Data collection methods:
High caries index will be assessed 3 times , at base line , then 15 days and 30 days.
Funding:
The research will be self-funded by the researcher.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aloe vera toothpaste | Experimental | Drug: aloe vera toothpastealoe vera toothpaste isa will be administrated 2 times per day for 30 days and salivary bacterial count will be tested before the use of toothpaste the after 15 days and 30 days |
| fluoride toothpaste | Active comparator | Drug: fluoride toothpastefluoride toothpaste isa herbal toothpaste will be administrated 2 times per day for 30 days and salivary bacterial count will be tested before the use of toothpaste the after 15 days and 30 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients should have poor oral hygiene.
- Patients should have high bacterial count
Key exclusion criteria (2 listed)
- Patients with a compromised medical history.
- Severe or active periodontal disease .
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 |
|---|---|---|
| aloe vera toothpasteAlso: aloe dent toothpaste, aloe dentherbal toothpaste used to decrease salivary streptococcus bacterial count | Drug | aloe vera toothpaste |
| fluoride toothpasteAlso: signal toothpastechemical toothpaste used to decrease salivary streptococcus bacterial count | Drug | fluoride toothpaste |
Primary outcome
salivary bacterial count
Time frame: average of 30 days
will be done using mitis salivarius agar plate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Background: PubMed 26539392Bhati N, Jaidka S, Somani R. Evaluation of antimicrobial efficacy of Aloe vera and Meswak containing dentifrices with fluoridated dentifrice: An in vivo study. J Int Soc Prev Community Dent. 2015 Sep-Oct;5(5):394-9. doi: 10.4103/2231-0762.165924.
- Individual participant dataSharing planned: Yes. publishing the data at egyptian dental journal
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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.
Amira Farid, PHD study director
professor at conservative department cairo university
Rasha Rafaat, PHD study chair
lecturer at conservative department cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aloe vera toothpaste and fluoride toothpaste in people with Caries, Dental, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 2 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 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Neven Ahmed Ebrahim, master (01153621944, nova480@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivary bacterial count (time frame: average of 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03108313, which also lists 1 linked publication.
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 31 Jul 2017.