Periodontal DiseasesPhase 2/3NCT02560870
Compare the Efficacy of Aloe Vera Mouthwash With Non- Alcoholic Chlorhexidine Mouthwash on Periodontal Diseases
A Phase 2/3 study testing Active Comparator:Aloe Vera mouthwash and Active Comparator:Chlorhexidine mouthwash in people with Periodontal Diseases, run by Islamic Azad University, Sanandaj.
Trial summary
Aim: To compare the efficacy of Aloe Vera and non-alcoholic chlorhexidine mouthwash in the treatment of Periodontal diseases. Methods \&Material: 32 patients were selected, the following periodontal parameters were recorded at baseline, and after recording all the parameters at the baseline, Scaling, root planning… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Active Comparator:Aloe Vera mouthwash and Active Comparator:Chlorhexidine mouthwash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to May 2015
- Phase
- Phase 2/3
- 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 Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Presence of two periodontal sites located on the same side pocket depth 4 mm or more.
- Chronic periodontitis patients.
Who cannot join
- Orthodontic treatment.
- Use removal denture.
- Presence of vertical bone defect.
- Use of medicine therapy within the 3 months prior to the study.
- Allergy to chlorhexidine and Aloe Vera.
- smoking.
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- Systemic diseases that could influence the course of periodontal disease.
- Pregnancy and lactation.
- Aggressive periodontitis.
- Furcation involvement.
- Periodontal therapy 6 months prior to the study.
- Extensive caries.
About this study
Official title: Randomized, Clinical Trial to Evaluate the Effects of Aloe Vera Mouthwash in Comparison With Non-alcoholic Chlorhexidine on Periodontal Disease
Aim: To compare the efficacy of Aloe Vera and non-alcoholic chlorhexidine mouthwash in the treatment of Periodontal diseases.
Methods \&Material: 32 patients were selected, the following periodontal parameters were recorded at baseline, and after recording all the parameters at the baseline, Scaling, root planning, and polishing are done for all the patients participating in the study. Oral hygiene instructions were given that included brushing twice a day with a soft brush, After 2 weeks, patients in the study, were randomly (Balanced Block Randomization) equal divided into 2 groups;
Group A: mouthwash aloe Vera (Alodent Co. UK) for each patient, Group B: Non-alcoholic Chlorhexidine (Perio-Kin, Livar CO. Spain) 10 ml by patients routinely washed two times in one day for about 30 seconds and lasts for 15 days, then every 7 days periodontal parameters, and at the end of 2 weeks (days 0, 7, 15) clinical changes are evaluated.
Read the detailed description
Eligible participants were 32 adult patients treated for chronic periodontitis and participating in a supportive periodontal therapy program at the Department of Periodontology of the Dental Clinic of the Islamic Azad University, Dental Branch of Tehran were included in the current study; Recruitment of participants started july 2014 and ended may 2015. The study met the criteria of the Helsinki Declaration of 1975, revised in 2008. The survey plan was reviewed and sanctioned, approved by the ethics commission of the Institutional Ethical Committee and Review Board of the Deputy of Research, School of Dentistry. All subjects received the oral and written explanation of the intent of the survey and signed an informed consent after receiving detailed information about the purpose, the benefits, and the possible risks associated with the trial. Individuals satisfying the following entry criteria were recruited:
- Diagnosed suffering from initial (early) to moderate chronic periodontitis;
- Adult patients, more than 28 years old with at least 20 remaining teeth and at least three teeth in each quadrant;
- The presence of at least two residual sites with a probing pocket depth (PPD>4 mm in two opposite quadrants, which showed bleeding upon probing, radiographically comparable amount of periodontal breakdown and good matching in tooth type, also clinical and minimal radiographic signs of initial (early) to moderate (clinical attachment level of 1 to 3mm.
- Conditions
- Periodontal Diseases
- Being tested
- Active Comparator:Aloe Vera mouthwash, Active Comparator:Chlorhexidine mouthwash
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator:Aloe Vera mouthwashDrug
Also called Aloe Vera mouthwash made by Alodent Co. UK
mouthwash( Aloe Vera),10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
Active Comparator:Chlorhexidine mouthwashDrug
Also called Chlorhexidine mouthwash made by Perio-Kin, Livar CO. Spain
mouthwash( Chlorhexidine ),10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aloe Vera mouthwash | Active comparator | mouthwash (Aleo Vera)10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks. Receives: Drug: Active Comparator:Aloe Vera mouthwash |
| Chlorhexidine mouthwash | Active comparator | mouthwash (Chlorhexidine )10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks. Receives: Drug: Active Comparator:Chlorhexidine mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pocket depth
Periodontal pobe
Measured: 7days
Secondary outcomes (2)
Reduction of bleeding on probing
Periodontal pobe
Measured: 7days
Reduction of plaque index
Plaque Index(O'Leary )
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startMar 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Sanandaj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amirhossein Farahmand, Islamic Azad University, Sanandaj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560870
- Sponsor's protocol ID
- 487
- Status last verified
- Jun 2016
- First submitted
- 24 Sep 2015
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Clinical Trial to Evaluate the Effects of Aloe Vera Mouthwash in Comparison With Non-alcoholic Chlorhexidine on Periodontal Disease
- ClinicalTrials.gov ID
- NCT02560870
- Acronym / sponsor ID
- 487
- Conditions
- Periodontal Diseases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Islamic Azad University, SanandajUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Sep 2015 (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.
Aim: To compare the efficacy of Aloe Vera and non-alcoholic chlorhexidine mouthwash in the treatment of Periodontal diseases.
Methods \&Material: 32 patients were selected, the following periodontal parameters were recorded at baseline, and after recording all the parameters at the baseline, Scaling, root planning, and polishing are done for all the patients participating in the study. Oral hygiene instructions were given that included brushing twice a day with a soft brush, After 2 weeks, patients in the study, were randomly (Balanced Block Randomization) equal divided into 2 groups;
Group A: mouthwash aloe Vera (Alodent Co. UK) for each patient, Group B: Non-alcoholic Chlorhexidine (Perio-Kin, Livar CO. Spain) 10 ml by patients routinely washed two times in one day for about 30 seconds and lasts for 15 days, then every 7 days periodontal parameters, and at the end of 2 weeks (days 0, 7, 15) clinical changes are evaluated.
Detailed description
Eligible participants were 32 adult patients treated for chronic periodontitis and participating in a supportive periodontal therapy program at the Department of Periodontology of the Dental Clinic of the Islamic Azad University, Dental Branch of Tehran were included in the current study; Recruitment of participants started july 2014 and ended may 2015. The study met the criteria of the Helsinki Declaration of 1975, revised in 2008. The survey plan was reviewed and sanctioned, approved by the ethics commission of the Institutional Ethical Committee and Review Board of the Deputy of Research, School of Dentistry. All subjects received the oral and written explanation of the intent of the survey and signed an informed consent after receiving detailed information about the purpose, the benefits, and the possible risks associated with the trial. Individuals satisfying the following entry criteria were recruited:
- Diagnosed suffering from initial (early) to moderate chronic periodontitis;
- Adult patients, more than 28 years old with at least 20 remaining teeth and at least three teeth in each quadrant;
- The presence of at least two residual sites with a probing pocket depth (PPD>4 mm in two opposite quadrants, which showed bleeding upon probing, radiographically comparable amount of periodontal breakdown and good matching in tooth type, also clinical and minimal radiographic signs of initial (early) to moderate (clinical attachment level of 1 to 3mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aloe Vera mouthwash | Active comparator | Drug: Active Comparator:Aloe Vera mouthwashmouthwash (Aleo Vera)10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks. |
| Chlorhexidine mouthwash | Active comparator | Drug: Active Comparator:Chlorhexidine mouthwashmouthwash (Chlorhexidine )10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks. |
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Presence of two periodontal sites located on the same side pocket depth 4 mm or more.
- Chronic periodontitis patients.
Key exclusion criteria (12 listed)
- Orthodontic treatment.
- Use removal denture.
- Presence of vertical bone defect.
- Use of medicine therapy within the 3 months prior to the study.
- Allergy to chlorhexidine and Aloe Vera.
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 |
|---|---|---|
| Active Comparator:Aloe Vera mouthwashAlso: Aloe Vera mouthwash made by Alodent Co. UKmouthwash( Aloe Vera),10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks. | Drug | Aloe Vera mouthwash |
| Active Comparator:Chlorhexidine mouthwashAlso: Chlorhexidine mouthwash made by Perio-Kin, Livar CO. Spainmouthwash( Chlorhexidine ),10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks. | Drug | Chlorhexidine mouthwash |
Primary outcome
Reduction of pocket depth
Time frame: 7days
Periodontal pobe
2 secondary outcomes
Reduction of bleeding on probing
Time frame: 7days
Reduction of plaque index
Time frame: 7days
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 6 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Active Comparator:Aloe Vera mouthwash and Active Comparator:Chlorhexidine mouthwash in people with Periodontal Diseases, run by Islamic Azad University, Sanandaj.
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 12 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 6 Jun 2016. 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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction of pocket depth (time frame: 7days). 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 6 Jun 2016.