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

NCT ID: NCT02560870

Last Updated: 2016-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-05-31

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.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Aloe Vera mouthwash

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

Group Type: ACTIVE_COMPARATOR

Active Comparator:Aloe Vera mouthwash

Intervention Type: DRUG

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

Chlorhexidine mouthwash

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

Group Type: ACTIVE_COMPARATOR

Active Comparator:Chlorhexidine mouthwash

Intervention Type: DRUG

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

Interventions

Active Comparator:Aloe Vera mouthwash

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

Intervention Type: DRUG

Active Comparator:Chlorhexidine mouthwash

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

Intervention Type: DRUG

Other Intervention Names

Aloe Vera mouthwash made by Alodent Co. UK; Chlorhexidine mouthwash made by Perio-Kin, Livar CO. Spain

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.

• Accepts Healthy Volunteers: Yes

Sponsors

Islamic Azad University, Sanandaj

OTHER

Sponsor Role: lead

Responsible Party

Amirhossein Farahmand

Evaluate and compare the efficacy of aloe Vera mouthwash with non- alcoholic Chlorhexidine mouthwash on periodontal diseases.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

487

Identifier Type: -

Identifier Source: org_study_id