Oral HygieneNCT03789812
Oral Hygiene in Patients With Orthodontic Fixed Appliances
A study testing Manual toothbrush, Electric Toothbrush and Superfloss in people with Oral Hygiene, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
Trial summary
The study aims to compare the efficacy of the use of different methods of teeth cleaning on the oral hygiene in patients with orthodontic fixed appliance Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Oral Hygiene
- What is being tested?
- Manual toothbrush, Electric Toothbrush and Superfloss
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 3 Dec 2018to 15 Jul 2019
- 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 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- participants with fixed orthodontic appliance.
- participants age 14 years and above and didn't have mental of physical disabilities.
- participants willing to comply with given oral hygiene instructions.
Who cannot join
- patients with mental retardation.
- patients with systematic diseases.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Omar AlKadhi
Riyadh, 11372
Omar AlKadhi, BDS, MS, 505154754, omar.alkadhi@riyadh.edu.sa
About this study
Official title: Efficacy of Different Methods of Teeth Cleaning on Oral Hygiene in Patients With Orthodontic Fixed Appliances
The study aims to compare the efficacy of the use of different methods of teeth cleaning on the oral hygiene in patients with orthodontic fixed appliance
Read the detailed description
Subjects were randomized into four groups, the first group will receive manual tooth brush with super floss, the second group will receive electric tooth brush with super floss, the third group will receive manual tooth brush with water dental flosser and the fourth group will receive electric tooth brush with water flosser.
- Conditions
- Oral Hygiene
- Being tested
- Manual toothbrush, Electric Toothbrush, Superfloss, Dental Water Jet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual toothbrushDevice
Soft manual toothbrush (Oral B) will be used to brush occlusal, buccal and lingual teeth surfaces.
Electric ToothbrushDevice
Electric toothbrush (Jetpik JP210) will be used to brush occlusal, buccal and lingual teeth surfaces.
SuperflossDevice
Superfloss (Oral B) will be used to clean interproximal teeth surfaces.
Dental Water JetDevice
Dental water jet (Jetpik JP210) will be used to clean interproximal teeth surfaces.
| Study group | Role | What they receive |
|---|---|---|
| Manual Toothbrush with Superfloss | Active comparator | Patients in this group will receive Manual Toothbrush (Oral B) and Superfloss (Oral B) and will be instructed to use them three times a day. Receives: Device: Manual toothbrush; Device: Superfloss |
| Electric Toothbrush with Superfloss | Experimental | Patients in this group will receive Electric Toothbrush (JETPIK) and Superfloss (Oral B) and will be instructed to use them three times a day. Receives: Device: Electric Toothbrush; Device: Superfloss |
| Manual Toothbrush with Water Flosser | Experimental | Patient in this group will receive Manual Toothbrush and Dental Water Jet and will be instructed to use them three times a day. Receives: Device: Manual toothbrush; Device: Dental Water Jet |
| Electric Toothbrush with Water Flosser | Experimental | Patient in this group will receive Electric tooth brush (JETPIK) and water flosser and will be instructed to use them three times a day. Receives: Device: Electric Toothbrush; Device: Dental Water Jet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plaque index
plaque index: 0 no plaque, 1 plaque seen only on tip of explorer or with disclosing agents, 2 plaque seen with naked eye, 3 abundance of plaque
Measured: baseline, after 4 weeks and after 8 weeks
Change in gingival index
gingival index: 0, normal gingiva, 1 mild inflammation- slight change in color, slight edema and bleeding on probing. 2 moderate inflammation - redness, edema and bleeding on probing. 3, sever inflammation - redness, edema, and tendency to spontaneous bleeding
Measured: baseline, after 4 weeks and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start3 Dec 2018
- Primary completion30 May 2019 (estimated)
- Study completion15 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Alkadhi, Riyadh Colleges of Dentistry and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789812
- Sponsor's protocol ID
- REU/Proposal2018
- Status last verified
- Dec 2018
- First submitted
- 27 Dec 2018
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Methods of Teeth Cleaning on Oral Hygiene in Patients With Orthodontic Fixed Appliances
- ClinicalTrials.gov ID
- NCT03789812
- Acronym / sponsor ID
- REU/Proposal2018
- Conditions
- Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 15 Jul 2019 (estimated)
- First posted
- 31 Dec 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.
The study aims to compare the efficacy of the use of different methods of teeth cleaning on the oral hygiene in patients with orthodontic fixed appliance
Detailed description
Subjects were randomized into four groups, the first group will receive manual tooth brush with super floss, the second group will receive electric tooth brush with super floss, the third group will receive manual tooth brush with water dental flosser and the fourth group will receive electric tooth brush with water flosser.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Manual Toothbrush with Superfloss | Active comparator | Device: Manual toothbrush, Device: SuperflossPatients in this group will receive Manual Toothbrush (Oral B) and Superfloss (Oral B) and will be instructed to use them three times a day. |
| Electric Toothbrush with Superfloss | Experimental | Device: Electric Toothbrush, Device: SuperflossPatients in this group will receive Electric Toothbrush (JETPIK) and Superfloss (Oral B) and will be instructed to use them three times a day. |
| Manual Toothbrush with Water Flosser | Experimental | Device: Manual toothbrush, Device: Dental Water JetPatient in this group will receive Manual Toothbrush and Dental Water Jet and will be instructed to use them three times a day. |
| Electric Toothbrush with Water Flosser | Experimental | Device: Electric Toothbrush, Device: Dental Water JetPatient in this group will receive Electric tooth brush (JETPIK) and water flosser and will be instructed to use them three times a day. |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- participants with fixed orthodontic appliance.
- participants age 14 years and above and didn't have mental of physical disabilities.
- participants willing to comply with given oral hygiene instructions.
Key exclusion criteria (2 listed)
- patients with mental retardation.
- patients with systematic diseases.
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 |
|---|---|---|
| Manual toothbrushSoft manual toothbrush (Oral B) will be used to brush occlusal, buccal and lingual teeth surfaces. | Device | Manual Toothbrush with Superfloss, Manual Toothbrush with Water Flosser |
| Electric ToothbrushElectric toothbrush (Jetpik JP210) will be used to brush occlusal, buccal and lingual teeth surfaces. | Device | Electric Toothbrush with Superfloss, Electric Toothbrush with Water Flosser |
| SuperflossSuperfloss (Oral B) will be used to clean interproximal teeth surfaces. | Device | Electric Toothbrush with Superfloss, Manual Toothbrush with Superfloss |
| Dental Water JetDental water jet (Jetpik JP210) will be used to clean interproximal teeth surfaces. | Device | Electric Toothbrush with Water Flosser, Manual Toothbrush with Water Flosser |
Primary outcome
Change in plaque index
Time frame: baseline, after 4 weeks and after 8 weeks
plaque index: 0 no plaque, 1 plaque seen only on tip of explorer or with disclosing agents, 2 plaque seen with naked eye, 3 abundance of plaque
Change in gingival index
Time frame: baseline, after 4 weeks and after 8 weeks
gingival index: 0, normal gingiva, 1 mild inflammation- slight change in color, slight edema and bleeding on probing. 2 moderate inflammation - redness, edema and bleeding on probing. 3, sever inflammation - redness, edema, and tendency to spontaneous bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2018.
- Individual participant dataSharing planned: No
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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 Manual toothbrush, Electric Toothbrush and Superfloss in people with Oral Hygiene, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
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 3 inclusion and 2 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 31 Dec 2018. 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 Saudi Arabia. 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. 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 Omar H Alkadhi (966505154754, omar.alkadhi@riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plaque index (time frame: baseline, after 4 weeks and after 8 weeks). The study lists 2 primary outcomes in all. 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 31 Dec 2018.