Compare the Efficacy of Aloe Vera Mouthwash With Non- Alcoholic Chlorhexidine Mouthwash on Periodontal Diseases
Primary Purpose
Periodontal Diseases
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Active Comparator:Aloe Vera mouthwash
Active Comparator:Chlorhexidine mouthwash
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases
Eligibility Criteria
Inclusion Criteria:
- Presence of two periodontal sites located on the same side pocket depth 4 mm or more.
- Chronic periodontitis patients.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Aloe Vera mouthwash
Chlorhexidine mouthwash
Arm Description
mouthwash (Aleo Vera)10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
mouthwash (Chlorhexidine )10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
Outcomes
Primary Outcome Measures
Reduction of pocket depth
Periodontal pobe
Secondary Outcome Measures
Reduction of bleeding on probing
Periodontal pobe
Reduction of plaque index
Plaque Index(O'Leary )
Full Information
NCT ID
NCT02560870
First Posted
September 24, 2015
Last Updated
June 3, 2016
Sponsor
Islamic Azad University, Tehran
1. Study Identification
Unique Protocol Identification Number
NCT02560870
Brief Title
Compare the Efficacy of Aloe Vera Mouthwash With Non- Alcoholic Chlorhexidine Mouthwash on Periodontal Diseases
Official Title
Randomized, Clinical Trial to Evaluate the Effects of Aloe Vera Mouthwash in Comparison With Non-alcoholic Chlorhexidine on Periodontal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Islamic Azad University, Tehran
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aloe Vera mouthwash
Arm Type
Active Comparator
Arm Description
mouthwash (Aleo Vera)10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
Arm Title
Chlorhexidine mouthwash
Arm Type
Active Comparator
Arm Description
mouthwash (Chlorhexidine )10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
Intervention Type
Drug
Intervention Name(s)
Active Comparator:Aloe Vera mouthwash
Other Intervention Name(s)
Aloe Vera mouthwash made by Alodent Co. UK
Intervention Description
mouthwash( Aloe Vera),10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
Intervention Type
Drug
Intervention Name(s)
Active Comparator:Chlorhexidine mouthwash
Other Intervention Name(s)
Chlorhexidine mouthwash made by Perio-Kin, Livar CO. Spain
Intervention Description
mouthwash( Chlorhexidine ),10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
Primary Outcome Measure Information:
Title
Reduction of pocket depth
Description
Periodontal pobe
Time Frame
7days
Secondary Outcome Measure Information:
Title
Reduction of bleeding on probing
Description
Periodontal pobe
Time Frame
7days
Title
Reduction of plaque index
Description
Plaque Index(O'Leary )
Time Frame
7days
10. Eligibility
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Presence of two periodontal sites located on the same side pocket depth 4 mm or more.
Chronic periodontitis patients.
Exclusion Criteria:
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.
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.
12. IPD Sharing Statement
Learn more about this trial
Compare the Efficacy of Aloe Vera Mouthwash With Non- Alcoholic Chlorhexidine Mouthwash on Periodontal Diseases
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