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

NCT02560870 | Completed Phase 2 DMC

• 1 other identifier: 487
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• Reduction of pocket depth

  Periodontal pobe

  7days

Secondary Outcomes (2)

• Reduction of bleeding on probing

  7days

• Reduction of plaque index

  7days

Study Arms (2)

Aloe Vera mouthwash

ACTIVE COMPARATOR

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

Chlorhexidine mouthwash

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Aloe Vera mouthwash made by Alodent Co. UK

Aloe Vera mouthwash

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.

Also known as: Chlorhexidine mouthwash made by Perio-Kin, Livar CO. Spain

Chlorhexidine mouthwash

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of two periodontal sites located on the same side pocket depth 4 mm or more.
• Chronic periodontitis patients.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Islamic Azad University, Sanandaj: lead

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Evaluate and compare the efficacy of aloe Vera mouthwash with non- alcoholic Chlorhexidine mouthwash on periodontal diseases.

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: September 25, 2015
• Study Start: March 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 6, 2016

Record last verified: 2016-06