Miswak Efficacy Compared With Chlorhexidine

Gingivitis Clinical Trial

— MiswakChlorx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607785
• Other study ID #: 2020DEN
• Status: Completed
• Phase: Early Phase 1
• Start date: January 15, 2020
• Est. completion date: March 15, 2020

Study information

• Verified date: October 2020
• Source: Al-Iraqia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• Miswak mouthwash group
Twice daily for seven days for two months

Device:
• Chlorhexidine gluconate mouthwash
Twice daily for seven days for two months

Locations

Country	Name	City	State
Iraq	Dunia Wadeea Sabea	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
Al-Iraqia University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation of gingiva	Change in Gingival index	2 months
Primary	Bleeding from gingiva	Change in index	2 months
Primary	Plaque in the gingiva	Change in index	2 months