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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases
• Intervention / Treatment: Drug: Active Comparator:Aloe Vera mouthwash; Drug: Active Comparator:Chlorhexidine mouthwash

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Aloe Vera mouthwash; mouthwash (Aleo Vera)10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.	Drug: 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.; Other Names: Aloe Vera mouthwash made by Alodent Co. UK
ACTIVE_COMPARATOR: Chlorhexidine mouthwash; mouthwash (Chlorhexidine )10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.	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.; Other Names: Chlorhexidine mouthwash made by Perio-Kin, Livar CO. Spain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of pocket depth	Periodontal pobe	7days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of bleeding on probing	Periodontal pobe	7days
Reduction of plaque index	Plaque Index(O'Leary )	7days

Collaborators and Investigators

• Sponsor: Islamic Azad University, Tehran

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: September 24, 2015
• First Submitted That Met QC Criteria: September 24, 2015
• First Posted (ESTIMATE): September 25, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): June 6, 2016
• Last Update Submitted That Met QC Criteria: June 3, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 487