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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02560870
• Other study ID #: 487
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 24, 2015
• Last updated: June 3, 2016
• Start date: March 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2016
• Source: Islamic Azad University, Tehran
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Islamic Azad University, Tehran

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of pocket depth	Periodontal pobe	7days	Yes
Secondary	Reduction of bleeding on probing	Periodontal pobe	7days	Yes
Secondary	Reduction of plaque index	Plaque Index(O'Leary )	7days	Yes