Dental CariesNCT03732040
Miswak Versus Standard Measures to Prevent the Incidence of Caries Young Egyptian Adults: A Randomized Controlled Clinical Trial
A study testing miswak stick, Miswak plus tooth brushing and tooth paste and Standard preventive measures (tooth brushing , interdental cleaning and mouth rinse use containing CHX and Fluoride) in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- miswak stick, Miswak plus tooth brushing and tooth paste and Standard preventive measures (tooth brushing , interdental cleaning and mouth rinse use containing CHX and Fluoride)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • patients with High caries risk
- 18-25 years
- Males or females
- Medically free patients
- Patients approving to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
6Th of October University
Cairo
rania rashad, msc, 01221302127, raniamaster@yahoo.com
About this study
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.
Read the 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).
- Conditions
- Dental Caries
- Being tested
- miswak stick, Miswak plus tooth brushing and tooth paste, Standard preventive measures (tooth brushing , interdental cleaning and mouth rinse use containing CHX and Fluoride)
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miswak stickOther
miswak stick use as preventive hygiene measures
Miswak plus tooth brushing and tooth pasteOther
use of miswak stick with tooth brushing and fluoride toothpaste for oral hygiene measures
Standard preventive measures (tooth brushing , interdental cleaning and mouth rinse use containing CHX and Fluoride)Other
use toothbrush with fluoride toothpaste and interdental cleaning by dental flossing and use mouth wash containing chlorohexadine
| Study group | Role | What they receive |
|---|---|---|
| standerd preventive measures | Sham comparator | tooth brushing twice daily with fluoride tooth paste and dental flossing and mouthwash Receives: Other: Standard preventive measures (tooth brushing , interdental cleaning and mouth rinse use containing CHX and Fluoride) |
| miswak stick | Experimental | use of miswak stick twice daily Receives: Other: miswak stick |
| Use of Miswak plus tooth brushing and tooth paste | Experimental | use of miswak stick and tooth brush with fluoride toothpaste twice daily Receives: Other: Miswak plus tooth brushing and tooth paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new caries lesions
visual tactil inspection
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Jan 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Rashad Omar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732040
- Sponsor's protocol ID
- 4112018
- Status last verified
- Feb 2020
- First submitted
- 4 Nov 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Miswak Versus Standard Measures to Prevent the Incidence of Caries Young Egyptian Adults: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03732040
- Acronym / sponsor ID
- 4112018
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 6 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standerd preventive measures | Sham comparator | Other: Standard preventive measures (tooth brushing , interdental cleaning and mouth rinse use containing CHX and Fluoride)tooth brushing twice daily with fluoride tooth paste and dental flossing and mouthwash |
| miswak stick | Experimental | Other: miswak stickuse of miswak stick twice daily |
| Use of Miswak plus tooth brushing and tooth paste | Experimental | Other: Miswak plus tooth brushing and tooth pasteuse of miswak stick and tooth brush with fluoride toothpaste twice daily |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • patients with High caries risk
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miswak stickmiswak stick use as preventive hygiene measures | Other | miswak stick |
| Miswak plus tooth brushing and tooth pasteuse of miswak stick with tooth brushing and fluoride toothpaste for oral hygiene measures | Other | Use of Miswak plus tooth brushing and tooth paste |
| Standard preventive measures (tooth brushing , interdental cleaning and mouth rinse use containing CHX and Fluoride)use toothbrush with fluoride toothpaste and interdental cleaning by dental flossing and use mouth wash containing chlorohexadine | Other | standerd preventive measures |
Primary outcome
Incidence of new caries lesions
Time frame: 12 months
visual tactil inspection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miswak stick, Miswak plus tooth brushing and tooth paste and Standard preventive measures (tooth brushing , interdental cleaning and mouth rinse use containing CHX and Fluoride) in people with Dental Caries, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania Rashad Omar R.R Omar Taha, Master (01221302127, raniamaster@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of new caries lesions (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.