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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Rania Rashad Omar R.R Omar Taha, Master contact

01221302127

raniamaster@yahoo.com

Egypt1 site, 1 recruiting
  • 6Th of October University

    Cairo

    rania rashad, msc, 01221302127, raniamaster@yahoo.com

    Recruiting

Other trials in Egypt

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 groups in NCT03732040
Study groupRoleWhat they receive
standerd preventive measuresSham comparatortooth 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 stickExperimentaluse of miswak stick twice daily
Receives: Other: miswak stick
Use of Miswak plus tooth brushing and tooth pasteExperimentaluse 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.

  1. 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.

  1. First posted6 Nov 2018
  2. Study start1 Jan 2019
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Mar 2022 (estimated)

Resources

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)
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

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.

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