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Completed

NCT Number: NCT02560870

Compare the Efficacy of Aloe Vera Mouthwash With Non- Alcoholic Chlorhexidine Mouthwash on Periodontal Diseases

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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Comparator:Aloe Vera mouthwash

Drug

mouthwash( Aloe Vera),10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.

Other names: Aloe Vera mouthwash made by Alodent Co. UK

Active Comparator:Chlorhexidine mouthwash

Drug

mouthwash( Chlorhexidine ),10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.

Other names: Chlorhexidine mouthwash made by Perio-Kin, Livar CO. Spain

Primary outcomes

  1. Reduction of pocket depth

    Time frame: 7days

    Periodontal pobe

Secondary outcomes

  1. Reduction of bleeding on probing

    Time frame: 7days

    Periodontal pobe

  2. Reduction of plaque index

    Time frame: 7days

    Plaque Index(O'Leary )

Sponsors and collaborators

Lead sponsor

Islamic Azad University, Sanandaj

Other

Registry information

Official study title

Randomized, Clinical Trial to Evaluate the Effects of Aloe Vera Mouthwash in Comparison With Non-alcoholic Chlorhexidine on Periodontal Disease

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 25, 2015
Registry last updated
Jun 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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