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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
Islamic Azad University, Tehran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Accepts Healthy Volunteers

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

    First Posted
    September 24, 2015
    Last Updated
    June 3, 2016
    Sponsor
    Islamic Azad University, Tehran
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    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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