Miswak Efficacy Compared With Chlorhexidine (MiswakChlorx)
Primary Purpose
Gingivitis
Status
Completed
Phase
Early Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
Miswak mouthwash group
Chlorhexidine gluconate mouthwash
Sponsored by
About this trial
This is an interventional supportive care trial for Gingivitis focused on measuring Miswak, chlorhexidine, mouthwash, gingivitis, oral health
Eligibility Criteria
Inclusion Criteria:
- Adults with existence at least 20 natural teeth in the mouth
- Existence of lateral maxillary teeth
- Existence of central teeth
- Existence of mandibular teeth
Exclusion Criteria:
- Patients have no history of drug use
- Patients have no any disease relevant occurrence
- Pocket depth<3 mm
- Smokers
- Pregnancy
Sites / Locations
- Dunia Wadeea Sabea
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Miswak mouthwash group
Chlorhexidine mouthwash group
Arm Description
Miswak sticks were bought from local markets, Baghdad, Iraq, washed with cold water and dried then crushed into powder. Later,7 grams of the miswak powder weighted and added to 350 ml of distilled water (D.W.) in a conical flask for 24 hours. Finally, the solution then filtered and stored in tightly closed bottles in a cool place.9
0.12% chlorhexidine gluconate mouthwash for seven days
Outcomes
Primary Outcome Measures
Inflammation of gingiva
Change in Gingival index
Bleeding from gingiva
Change in index
Plaque in the gingiva
Change in index
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04607785
Brief Title
Miswak Efficacy Compared With Chlorhexidine
Acronym
MiswakChlorx
Official Title
The Comparative Evaluation of Efficacy of 40% Miswak Mouthwash With 0.12% Chlorhexidine Mouthwash Among Gingivitis: A Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Iraqia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Gingivitis is a form of gum disease and is elicited by the accumulation of plaque on the tooth and the soft-tissue adjoining the tooth. Mouthwashes containing chemical or herbal substances are adjunctive tools in improving oral hygiene. Miswak mouthwash is a herbal mouthwash. Chlorhexidine mouthwash is the most efficient antimicrobial and antiplaque agent. The aim of the study is to assess the effectiveness of the miswak mouthwash with 0.12% chlorhexidine. This study was a blind randomized clinical trial.
Materials and Methods: A total of 60 patients aged (20-55) years old who attended the Periodontics Clinics at College of Dentistry, Al-Iraqia University were allocated for use the mouthwash either miswak mouthwash or 0.12% chlorhexidine gluconate Kin Gingival® (Laboratorios KIN, Spain) twice daily (once in the morning and one before bedtime) for seven days. Gingival, bleeding, and plaque indices were recorded at baseline and after 7 days of treatment.
Detailed Description
Gingivitis is the mildest form of gum disease and is elicited by the accumulation of plaque on the tooth and the soft-tissue adjoining the tooth. Accumulation of dental biofilm has been established as the initial cause of this disease. It is determined by redness of the gum margins, edema, bleeding upon brushing, and loss of periodontal attachment loss. Gingivitis exists in both acute and chronic forms. Acute gingivitis is identified as trauma, micro-organisms, and specific infections while chronic inflammation is related to bacterial biofilm which covers the gum and adjoining the teeth. Elimination and control of plaque are very important in the maintenance of periodontal health. Chlorhexidine mouthwash has is a tremendous effect when it is used as a mouthwash for a long time; therefore, the Food and Drug Administration (FDA) recommends limiting the use of chlorhexidine mouthwash up to 6 months to minimize or limit its side effects. Additionally, the World Health Organization (WHO) encouraged to consider the possible use of herb extracts and natural plants mouthwashes instead of chemical mouthwash just as miswak mouthwash. Miswak mouthwash is a herbal mouthwash that is available locally and culturally accepted. It is prepared from a plant called Salvadora persica which comes from a tree (Arak) that grows in Africa and west India.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
Miswak, chlorhexidine, mouthwash, gingivitis, oral health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Miswak mouthwash group
Arm Type
Active Comparator
Arm Description
Miswak sticks were bought from local markets, Baghdad, Iraq, washed with cold water and dried then crushed into powder. Later,7 grams of the miswak powder weighted and added to 350 ml of distilled water (D.W.) in a conical flask for 24 hours. Finally, the solution then filtered and stored in tightly closed bottles in a cool place.9
Arm Title
Chlorhexidine mouthwash group
Arm Type
Other
Arm Description
0.12% chlorhexidine gluconate mouthwash for seven days
Intervention Type
Drug
Intervention Name(s)
Miswak mouthwash group
Intervention Description
Twice daily for seven days for two months
Intervention Type
Device
Intervention Name(s)
Chlorhexidine gluconate mouthwash
Other Intervention Name(s)
chlorhexidine gluconate Kin Gingival®
Intervention Description
Twice daily for seven days for two months
Primary Outcome Measure Information:
Title
Inflammation of gingiva
Description
Change in Gingival index
Time Frame
2 months
Title
Bleeding from gingiva
Description
Change in index
Time Frame
2 months
Title
Plaque in the gingiva
Description
Change in index
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with existence at least 20 natural teeth in the mouth
Existence of lateral maxillary teeth
Existence of central teeth
Existence of mandibular teeth
Exclusion Criteria:
Patients have no history of drug use
Patients have no any disease relevant occurrence
Pocket depth<3 mm
Smokers
Pregnancy
Facility Information:
Facility Name
Dunia Wadeea Sabea
City
Baghdad
ZIP/Postal Code
10001
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No need
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Miswak Efficacy Compared With Chlorhexidine
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