Miswak Versus Standard Measures to Prevent the Incidence of Caries Young Egyptian Adults: A Randomized Controlled Clinical Trial
Primary Purpose
Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
miswak stick
Miswak plus tooth brushing and tooth paste
Standard preventive measures (tooth brushing , interdental cleaning and mouth rinse use containing CHX and Fluoride)
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
• patients with High caries risk
- 18-25 years
- Males or females
- Medically free patients
- Patients approving to participate in the study
Exclusion Criteria:
- Patients were on antibiotic therapy or corticosteroid therapy for 30 days before the examination
- Patients had history of professional cleaning in the last 15 days
- Patients with exposed pulp
- Evidence of parafunctional habits
- Patients with developmental dental anomalies
- Patients undergoing or will start orthodontic treatment
- Patients with removable prosthesis
- Periapical Abscess or Fistula
Sites / Locations
- 6Th of October UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
Experimental
Experimental
Arm Label
standerd preventive measures
miswak stick
Use of Miswak plus tooth brushing and tooth paste
Arm Description
tooth brushing twice daily with fluoride tooth paste and dental flossing and mouthwash
use of miswak stick twice daily
use of miswak stick and tooth brush with fluoride toothpaste twice daily
Outcomes
Primary Outcome Measures
Incidence of new caries lesions
visual tactil inspection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03732040
Brief Title
Miswak Versus Standard Measures to Prevent the Incidence of Caries Young Egyptian Adults: A Randomized Controlled Clinical Trial
Official Title
Miswak Versus Standard Measures to Prevent the Incidence of Caries Young Egyptian Adults: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Objectives:
Aim of the study The objective is to conduct an RCT to evaluate the effectiveness of miswak in comparison with standard caries preventive measures for the prevention of new carious lesions in high caries risk patients.
-Research hypothesis (alternative hypothesis): This study will be designed to test the alternative hypothesis that using miswak in addition to standard preventive measures will show significant difference over using standard preventive measures alone in preventing incidence of new carious lesions in high caries risk patients.
Detailed Description
- General procedures The study will be announced at the Faculty of Oral and Dental Medicine, 6 October University campus to encourage interested students to participate in the study.
Interested participants will be screened at Conservative Department clinic for eligibility by (M.M). Eligible participants will be assessed using caries risk assessment tool by (R.R.).
Eligible participants will be randomly divided into three groups 1st group will follow only standard preventive measures(tooth brushing and tooth paste plus interdental cleaning and mouth rinse using CHX and Fluoride) , 2nd group will use miswak for oral hygiene measures and 3rd group will use of miswak plus tooth brushing and tooth paste.
Before starting the study the eligible participants will undergo supragingival, subgingival scaling and prophylaxis polishing, then any carious cavity, or defective restoration will be treated and filled with resin composite restoration.
New set of manual brushes and dental floss will be given to the participants, after they are properly trained for the correct brushing and flossing technique. The participants will be asked to brush their teeth twice a day with fluoride tooth paste and to clean their teeth interdentally with dental floss once a day every day till the end of the study(Group 1 and 3 only) 11b- Preparation of miswak
Procedure of preparing Miswak:
Miswak has its own unique aspects that must be adapted prior to use for the best results. The functional end of a thin bark piece is striped off followed by chewing. Chewing of miswak separates fibers and giving it a brush like appearance that helps in cleaning the teeth easily. The recommended length for a stick is about 15 cm so that it can easily be grasped along with ease to carry around, whereas, the diameter is preferred to be <1 cm.(16) There are two methods documented to hold the miswak. One is the three finger grip technique and the other is five finger grip technique The aim of both techniques is to make sure that all surfaces of the teeth are accessible and cleaned with convenience and controlled movements of the stick in the oral cavity. In order to clean the tooth surfaces, the fibers of miswak should be held perpendicular to the tooth surface and gently moved in up and down motions, directed away from the gingival margins on both the buccal and lingual surfaces(17) .
11c-For the intervention group After recording the primary data, Miswak will be given to the intervention group and they will be trained and asked to use it two times per day. The demonstrations and instructions for chewing stick users will include the technique of preparation of working end of chewing sticks and its appropriate brushing technique. The sticks which are not prepared are instructed to be refrigerated. (13)(14).(group 2 and 3)
- For the control group Participants in this group will follow only the standard preventive measures which is brushing twice a day after breakfast and before bed time and daily flossing interdentally before bed time and mouth rinse containing CHX and fluoride.
In all study groups if any patient during the period of the study develops any carious cavity, the affected tooth will be treated immediately and restored with resin composite restoration.
. Outcomes: Visual inspection to detect presence or absence of new caries lesions will be done according to WHO guidelines by using CPI Probe (15).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standerd preventive measures
Arm Type
Sham Comparator
Arm Description
tooth brushing twice daily with fluoride tooth paste and dental flossing and mouthwash
Arm Title
miswak stick
Arm Type
Experimental
Arm Description
use of miswak stick twice daily
Arm Title
Use of Miswak plus tooth brushing and tooth paste
Arm Type
Experimental
Arm Description
use of miswak stick and tooth brush with fluoride toothpaste twice daily
Intervention Type
Other
Intervention Name(s)
miswak stick
Intervention Description
miswak stick use as preventive hygiene measures
Intervention Type
Other
Intervention Name(s)
Miswak plus tooth brushing and tooth paste
Intervention Description
use of miswak stick with tooth brushing and fluoride toothpaste for oral hygiene measures
Intervention Type
Other
Intervention Name(s)
Standard preventive measures (tooth brushing , interdental cleaning and mouth rinse use containing CHX and Fluoride)
Intervention Description
use toothbrush with fluoride toothpaste and interdental cleaning by dental flossing and use mouth wash containing chlorohexadine
Primary Outcome Measure Information:
Title
Incidence of new caries lesions
Description
visual tactil inspection
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• patients with High caries risk
18-25 years
Males or females
Medically free patients
Patients approving to participate in the study
Exclusion Criteria:
Patients were on antibiotic therapy or corticosteroid therapy for 30 days before the examination
Patients had history of professional cleaning in the last 15 days
Patients with exposed pulp
Evidence of parafunctional habits
Patients with developmental dental anomalies
Patients undergoing or will start orthodontic treatment
Patients with removable prosthesis
Periapical Abscess or Fistula
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rania Rashad Omar R.R Omar Taha, Master
Phone
01221302127
Email
raniamaster@yahoo.com
Facility Information:
Facility Name
6Th of October University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rania rashad, msc
Phone
01221302127
Email
raniamaster@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Miswak Versus Standard Measures to Prevent the Incidence of Caries Young Egyptian Adults: A Randomized Controlled Clinical Trial
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