Miswak Efficacy Compared With Chlorhexidine (MiswakChlorx)

The Comparative Evaluation of Efficacy of 40% Miswak Mouthwash With 0.12% Chlorhexidine Mouthwash Among Gingivitis: A Blind Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: Miswak mouthwash group; Device: Chlorhexidine gluconate mouthwash

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq, 10001
    • Dunia Wadeea Sabea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Miswak mouthwash group; 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	Drug: Miswak mouthwash group; Twice daily for seven days for two months; Device: Chlorhexidine gluconate mouthwash; Twice daily for seven days for two months; Other Names: chlorhexidine gluconate Kin Gingival®
OTHER: Chlorhexidine mouthwash group; 0.12% chlorhexidine gluconate mouthwash for seven days	Drug: Miswak mouthwash group; Twice daily for seven days for two months; Device: Chlorhexidine gluconate mouthwash; Twice daily for seven days for two months; Other Names: chlorhexidine gluconate Kin Gingival®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation of gingiva	Change in Gingival index	2 months
Bleeding from gingiva	Change in index	2 months
Plaque in the gingiva	Change in index	2 months

Collaborators and Investigators

• Sponsor: Al-Iraqia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2020
• Primary Completion (ACTUAL): March 15, 2020
• Study Completion (ACTUAL): March 15, 2020

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (ACTUAL): October 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 31, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: chlorhexidine; oral health; gingivitis; mouthwash; Miswak
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 2020DEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No need

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No