GingivitisNCT02235532
Effects of Aloe Vera Toothpaste on Periodontal Parameters
A study testing Foramen Herbal Aloe toothpaste and fluoride toothpaste in people with Gingivitis, run by Islamic Azad University, Sanandaj at 1 site in Iran.
Trial summary
This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and gingivitis. The single-blind cross-over clinical trial was conducted on 20 dental students (10 males and 10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided into 2 groups. Read more about this study
- Who is it for?
- Ages 20 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Foramen Herbal Aloe toothpaste and fluoride toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Sep 2013to Jun 2014
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects were selected among dental students with at least 20 natural teeth without systemic disease
- No periodontal treatment at least 6 months to the study
- No use of systemic antibiotic and anti-inflammatory drugs within the last 3 months, nonsmokers, no pregnancy or lactating women
- Subjects with PD≤3mm, (clinical attachment level)CAL<1mm, PI≥2 and gingival bleeding in more than 30% of the tested areas were enrolled with the diagnosis of plaque-related gingivitis.
Who cannot join
- Subjects with orthodontic appliances ,multiple bridges, partial denture, multiple caries were excluded from the study
Trial locations and contacts
1 site in 1 country.
Iran1 site
Tehran Dental Branch, Islamic azad University
Tehran, Tehran Province, 19585175
About this study
Official title: Effects of Aloe Vera Toothpaste on Periodontal Parameters of Patients With Gingivitis
This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and gingivitis.
The single-blind cross-over clinical trial was conducted on 20 dental students (10 males and 10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided into 2 groups. The first group used Aloe Vera toothpaste for 30 days. A 2-week wash-out period was allowed and then subjects used fluoride toothpaste for the next 30 days . This order was reversed in group 2.
Read the detailed description
Toothpastes are used with tooth brushing to better control microbial plaque. Herbal toothpastes have recently gained attention. This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and gingivitis.
This single-blind cross-over clinical trial was conducted on 20 dental students (10 males and 10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided into 2 groups. The first group used Aloe Vera toothpaste for 30 days and then their plaque index (PI) and gingival index (GI) were recorded. A 2-week wash-out period was allowed and then subjects used fluoride toothpaste for the next 30 days and underwent PI and GI assessment again. This order was reversed in group 2. Wilcoxon-Sign Rank and two way Repeated Measure ANOVA tests were applied for statistical analysis.
- Conditions
- Gingivitis
- Being tested
- Foramen Herbal Aloe toothpaste, fluoride toothpaste
- Keywords
- clinical trial, oral hygiene, Gingivitis, Aloevera, Toothpaste, anti-inflammatory agents
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foramen Herbal Aloe toothpasteOther
use of aloe-vera toothpaste for 30 days in the test group.
fluoride toothpasteOther
Also called signal
use of signal toothpaste once a day for 30 days in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Foramen Herbal Aloe toothpaste | Experimental | test group was asked to brush the teeth with Foramen Herbal Aloe toothpaste for 30 days once a day. Receives: Other: Foramen Herbal Aloe toothpaste |
| use of fluoride toothpaste (signal) | Active comparator | use of a fluoride toothpaste (signal) in control group once a day for 30 days . Receives: Other: fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring gingival index
to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the gingival index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.
Measured: 1-2days
Secondary outcomes (2)
measuring gingival index
to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the gingival index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.
Measured: 1-2 days
measuring plaque index
to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the plaque index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Sanandaj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferena Sayar, Islamic Azad University, Sanandaj
- Investigators
- Ferena Sayar, DDS;MSc, Principal investigator, Tehran Dental Branch, Islamic Azad University,Tehran/Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235532
- Sponsor's protocol ID
- IRCT2014040517053N2
- Status last verified
- Jan 2015
- First submitted
- 30 Aug 2014
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aloe Vera Toothpaste on Periodontal Parameters of Patients With Gingivitis
- ClinicalTrials.gov ID
- NCT02235532
- Acronym / sponsor ID
- IRCT2014040517053N2
- Conditions
- Gingivitis
- Keywords
- clinical trial, oral hygiene, Gingivitis, Aloevera, Toothpaste, anti-inflammatory agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Islamic Azad University, SanandajUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Sep 2014 (estimated)
- 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 study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and gingivitis.
The single-blind cross-over clinical trial was conducted on 20 dental students (10 males and 10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided into 2 groups. The first group used Aloe Vera toothpaste for 30 days. A 2-week wash-out period was allowed and then subjects used fluoride toothpaste for the next 30 days . This order was reversed in group 2.
Detailed description
Toothpastes are used with tooth brushing to better control microbial plaque. Herbal toothpastes have recently gained attention. This study aimed to assess the effects of Aloe Vera toothpaste on dental plaque and gingivitis.
This single-blind cross-over clinical trial was conducted on 20 dental students (10 males and 10 females with a mean age of 24.5±4 yrs.) with gingivitis. Students were randomly divided into 2 groups. The first group used Aloe Vera toothpaste for 30 days and then their plaque index (PI) and gingival index (GI) were recorded. A 2-week wash-out period was allowed and then subjects used fluoride toothpaste for the next 30 days and underwent PI and GI assessment again. This order was reversed in group 2. Wilcoxon-Sign Rank and two way Repeated Measure ANOVA tests were applied for statistical analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Foramen Herbal Aloe toothpaste | Experimental | Other: Foramen Herbal Aloe toothpastetest group was asked to brush the teeth with Foramen Herbal Aloe toothpaste for 30 days once a day. |
| use of fluoride toothpaste (signal) | Active comparator | Other: fluoride toothpasteuse of a fluoride toothpaste (signal) in control group once a day for 30 days . |
Who may qualify
- Ages
- 20 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects were selected among dental students with at least 20 natural teeth without systemic disease
- No periodontal treatment at least 6 months to the study
- No use of systemic antibiotic and anti-inflammatory drugs within the last 3 months, nonsmokers, no pregnancy or lactating women
- Subjects with PD≤3mm, (clinical attachment level)CAL<1mm, PI≥2 and gingival bleeding in more than 30% of the tested areas were enrolled with the diagnosis of plaque-related gingivitis.
Key exclusion criteria (1 listed)
- Subjects with orthodontic appliances ,multiple bridges, partial denture, multiple caries were excluded from the study
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 |
|---|---|---|
| Foramen Herbal Aloe toothpasteuse of aloe-vera toothpaste for 30 days in the test group. | Other | Foramen Herbal Aloe toothpaste |
| fluoride toothpasteAlso: signaluse of signal toothpaste once a day for 30 days in the control group. | Other | use of fluoride toothpaste (signal) |
Primary outcome
measuring gingival index
Time frame: 1-2days
to compare the efficacy of the aloe-vera toothpaste with a known conventional toothpaste, the gingival index was recorded at baseline and after 30 days of consumption and compared with the two understudy toothpastes.
2 secondary outcomes
measuring gingival index
Time frame: 1-2 days
measuring plaque index
Time frame: 1-2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
Related trials for Gingivitis
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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.
Ferena Sayar, DDS;MSc principal investigator
Tehran Dental Branch, Islamic Azad University,Tehran/Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foramen Herbal Aloe toothpaste and fluoride toothpaste in people with Gingivitis, run by Islamic Azad University, Sanandaj at 1 site in Iran.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jan 2015. 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 Iran. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring gingival index (time frame: 1-2days). 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 14 Jan 2015.