Miswak Efficacy Compared With Chlorhexidine

NCT04607785 | Completed Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 2020DEN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Keywords

Miswak; chlorhexidine; mouthwash; gingivitis; oral health

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Miswak mouthwash group

ACTIVE COMPARATOR

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; Device: Chlorhexidine gluconate mouthwash

Chlorhexidine mouthwash group

OTHER

0.12% chlorhexidine gluconate mouthwash for seven days

Drug: Miswak mouthwash group; Device: Chlorhexidine gluconate mouthwash

Interventions

Miswak mouthwash group DRUG

Twice daily for seven days for two months

Chlorhexidine mouthwash group; Miswak mouthwash group

Chlorhexidine gluconate mouthwash DEVICE

Twice daily for seven days for two months

Also known as: chlorhexidine gluconate Kin Gingival®

Chlorhexidine mouthwash group; Miswak mouthwash group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults with existence at least 20 natural teeth in the mouth
• Existence of lateral maxillary teeth
• Existence of central teeth
• Existence of mandibular teeth

You may not qualify if:

• Patients have no history of drug use
• Patients have no any disease relevant occurrence
• Pocket depth\<3 mm
• Smokers
• Pregnancy

Sponsors & Collaborators

• Al-Iraqia University: lead

Study Sites (1)

Dunia Wadeea Sabea

Baghdad, 10001, Iraq

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 29, 2020
• Study Start: January 15, 2020
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)