Dental PlaqueNCT07240428
Comparison Between Interdental Brush and Water Floss on Plaque Accumulation and Gingival Inflammation in Patients Undergoing Fixed Orthodontic Treatment.
A study testing Interdental brush and Water floss in people with Dental Plaque and Gingival Bleeding, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
The goal of this clinical trial is to test the ability of water flosser to remove plaque and reduce gingival inflammation in patients undergoing fixed orthodontic treatment. The main questions it aims to answer are: Does water flosser remove plaque effectively in orthodontic patients? Does water flosser reduce gum… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Gingival Bleeding
- What is being tested?
- Interdental brush and Water floss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteJordan
- Study dates
- 1 Jul 2024to 30 Mar 2025
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with fixed orthodontic appliance upper and lower arches.
- Patients with healthy gingiva with no periodontal disease.
- Patient's orthodontic plan doesn't require extraction of any teeth during the study period.
- Patients should have at least 26 teeth.
- Patients are motivated and able to clean their teeth.
- Patients should not have caries, overhang restorations, crowns, bridges or implants.
- Adults 18-35 years old.
Who cannot join
- Smokers.
- Medically compromised patients.
- Pregnant woman.
- Using mouth wash or antibiotic in last 3 months.
Trial locations and contacts
1 site in 1 country.
Jordan1 site
Jordan University of Science and Technology, Faculty of Dentistry
Irbid, Irbid Governorate, 22110
About this study
Official title: Comparison Between Interdental Brush and Water Floss on Plaque Accumulation and Gingival Inflammation in Patients Undergoing Fixed Orthodontic Treatment: A Single Blinded Split-Mouth Randomized Controlled Clinical Trial
The goal of this clinical trial is to test the ability of water flosser to remove plaque and reduce gingival inflammation in patients undergoing fixed orthodontic treatment.
The main questions it aims to answer are:
Read more
Does water flosser remove plaque effectively in orthodontic patients? Does water flosser reduce gum inflammation in orthodontic patients?
Researchers compared water flosser to interdental brush to see if there is a difference in plaque and inflammation reduction.
Participants used interdental brush to clean between their teeth and around brackets in one side of their mouth, and they used water flosser to clean between the teeth and around brackets in the other side. The study lasted for 3 months.
Read the detailed description
- Study design This is a randomized controlled single blinded clinical trial, with split mouth design.
- Sample size Forty seven subjects with fixed orthodontic appliance were recruited from patients attending dental teaching clinics at Jordan University of Science and Technology. The age range was between 18 and 35 years. They were randomly assigned to use interdental brush on one side of the mouth, and water floss on the other side in a split mouth design.
The study lasted for 3 months.
- Inclusion criteria:
- Patients with fixed orthodontic appliance in the upper and lower arches. 2. Patients with healthy gingiva with no periodontal disease. 3. Patient's orthodontic plan doesn't require extraction of any teeth during the study period. .
- Patients should have at least 26 teeth. 5. Patients are motivated and able to clean their teeth. 6. Patients should not have caries, overhang restorations, crowns, bridges or implants 7. Adults 18-35 years old.
- Exclusion criteria:
- Smokers 2. Medically compromised patients 3. Pregnant woman.
- Ethical considerations The study was approved by the Institutional Review Board (IRB) of Jordan University of Science and Technology (51/166/2024). All participating patients were informed of the study's purpose, objectives, and methods. They all provided a written informed consent before data collection.
- Data collection:
- Patients randomly used water floss on one side of the mouth , and the interdental brush on the other side.
- Randomization was used to assign the intervention to either the left or right side of the mouth. The following will be assessed 1- Plaque score using Rustogi modified navy plaque index for buccal and lingual surfaces, where the tooth was divided into multiple zones as the following : The divided zones are: Whole mouth: areas A,B,C,D,E,F,G and H. Marginal (gum line): areas A,B and C. Interproximal: areas D and F 0 score was given the area where there is no plaque. 1 score was given in the area where there is plaque Intraoral photos using professional camera were taken for all teeth and all surfaces to record the plaque score.
- gingival inflammation was recorded using gingival index at six sites per tooth (distobuccal, midbuccal, mesiobuccal, distolingual/palatal, midlingual/palatal, mesiolingual/palatal) as follows : 0= Normal gingiva.
- Mild inflammation - slight change in colour and slight edema but no bleeding on probing.
- Moderate inflammation - redness, edema and glazing, bleeding on probing.
- Severe inflammation - marked redness and edema, ulceration with tendency for spontaneous bleeding. 3.Visual Analog Scale (VAS) visual analog scale from 0 - 10 (0 - unsatisfied, uncomfortable, or difficult to use, 10 -very satisfied, comfortable, and easy to use) in each visit was taken. Randomization and Blinding Independent of the clinical assessment, a third-party dentist used a computer-generated random number sequence to determine which side of each patient's mouth will be cleaned by interdental brush and which side will be cleaned by the oral irrigator. While participants were aware of which device they were using on each side, the examiner who performed the clinical examinations was blinded.
- Adverse events monitoring: Participants were monitored for adverse events during the study period such as gingival trauma, sensitivity, recession, tooth or restoration damage.
- Conditions
- Dental Plaque, Gingival Bleeding
- Being tested
- Interdental brush, Water floss
- Keywords
- Interdental cleaning, Interdental brush, Water flosser, Oral hygiene, Orthodontic patients, Gingival inflammation, Plaque index, Oral irrigator
- Medical subject headings
- Dental Plaque, Gingival Hemorrhage, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdental brushDevice
Participants used an interdental brush twice daily after toothbrushing on the assigned side. This method was compared to the use of water floss in the contralateral side (split-mouth design).
Water flossDevice
Participants used a water flosser twice daily after toothbrushing on the assigned side. Standard pressure setting and specialized tip were used. This method was compared to the use of an interdental brush in the contralateral quadrants (split-mouth design).
| Study group | Role | What they receive |
|---|---|---|
| Interdental brush | Experimental | Participants used an interdental brush twice daily for interdental cleaning on the assigned side Receives: Device: Interdental brush |
| Water Flosser | Experimental | Participants used a water flosser twice daily for interdental cleaning on the other assigned side Receives: Device: Water floss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index
Plaque accumulation assessed using the Rustogi Modified Navy Plaque Index (RMNPI) on designated tooth surfaces in the sides assigned to interdental brush and water flosser. The tooth was divided into multiple zones as the following :
Whole mouth: areas A,B,C,D,E,F,G and H. Marginal (gum line): areas A,B and C. Interproximal: areas D and F
0 score was given the area where there is no plaque.
1 score was given in the area where there is plaque The minimum plaque score per surface (buccal or lingual) is zero, and the maximum plaque score per surface is 8 Intraoral photos using professional camera were taken for all teeth and all surfaces to record the plaque score.
Measured: Baseline, 2 weeks, 4 weeks, 2 month and 3 months
Secondary outcomes (2)
Gingival Index
Gingival inflammation was recorded using gingival index at six sites per tooth (distobuccal, midbuccal, mesiobuccal, distolingual/palatal, midlingual/palatal, mesiolingual/palatal) in each intervention side as follows :
0= Normal gingiva.
- Mild inflammation - slight change in colour and slight edema but no bleeding on probing.
- Moderate inflammation - redness, edema and glazing, bleeding on probing.
- Severe inflammation - marked redness and edema, ulceration with tendency for spontaneous bleeding.
The minumn score is zero and the maximum score for one surface (buccal or lingual/palatal is 9.
Measured: Baseline, 2 weeks, 4 weeks, 2 months ,and 3 months
Visual Analog Scale (VAS)
visual analog scale from 0 - 10 (0 - unsatisfied, uncomfortable, or difficult to use, 10 -very satisfied, comfortable, and easy to use)
Measured: 2 Weeks, 4 weeks, 2months, and 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jul 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies 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
- Model description
- Split-mouth randomized controlled clincal trial, where each participant receives one interdental cleaning method for the right side, and another one for the left side.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Principal investigator, Lana Bader, Jordan University of Science and Technology
- Investigators
- Lana Bader, DClinDent, Study director, Jordan University of Science and TechnologyReem Sami Abed Alhafez, DClinDent Perio, Study director, Jordan University of Science and TechnologyAhmad shawqi, MClinDent Perio, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240428
- Sponsor's protocol ID
- 775/2023
- Other IDs
- 51/166/2024
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data for plaque index (RMNPI), gingival index and patient-reported outcomes will be shared. Data will be stripped of all identifiers to protect participants privacy.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Interdental Brush and Water Floss on Plaque Accumulation and Gingival Inflammation in Patients Undergoing Fixed Orthodontic Treatment: A Single Blinded Split-Mouth Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07240428
- Acronym / sponsor ID
- 775/2023
- Conditions
- Dental Plaque, Gingival Bleeding
- Keywords
- Interdental cleaning, Interdental brush, Water flosser, Oral hygiene, Orthodontic patients, Gingival inflammation, Plaque index, Oral irrigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 20 Nov 2025 (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 goal of this clinical trial is to test the ability of water flosser to remove plaque and reduce gingival inflammation in patients undergoing fixed orthodontic treatment.
The main questions it aims to answer are:
Does water flosser remove plaque effectively in orthodontic patients? Does water flosser reduce gum inflammation in orthodontic patients?
Researchers compared water flosser to interdental brush to see if there is a difference in plaque and inflammation reduction.
Participants used interdental brush to clean between their teeth and around brackets in one side of their mouth, and they used water flosser to clean between the teeth and around brackets in the other side. The study lasted for 3 months.
Detailed description
- Study design This is a randomized controlled single blinded clinical trial, with split mouth design.
- Sample size Forty seven subjects with fixed orthodontic appliance were recruited from patients attending dental teaching clinics at Jordan University of Science and Technology. The age range was between 18 and 35 years. They were randomly assigned to use interdental brush on one side of the mouth, and water floss on the other side in a split mouth design.
The study lasted for 3 months.
- Inclusion criteria:
- Patients with fixed orthodontic appliance in the upper and lower arches. 2. Patients with healthy gingiva with no periodontal disease. 3. Patient's orthodontic plan doesn't require extraction of any teeth during the study period. .
- Patients should have at least 26 teeth. 5. Patients are motivated and able to clean their teeth. 6. Patients should not have caries, overhang restorations, crowns, bridges or implants 7. Adults 18-35 years old.
- Exclusion criteria:
- Smokers 2. Medically compromised patients 3. Pregnant woman.
- Ethical considerations The study was approved by the Institutional Review Board (IRB) of Jordan University of Science and Technology (51/166/2024). All participating patients were informed of the study's purpose, objectives, and methods. They all provided a written informed consent before data collection.
- Data collection:
- Patients randomly used water floss on one side of the mouth , and the interdental brush on the other side.
- Randomization was used to assign the intervention to either the left or right side of the mouth. The following will be assessed 1- Plaque score using Rustogi modified navy plaque index for buccal and lingual surfaces, where the tooth was divided into multiple zones as the following : The divided zones are: Whole mouth: areas A,B,C,D,E,F,G and H. Marginal (gum line): areas A,B and C. Interproximal: areas D and F 0 score was given the area where there is no plaque. 1 score was given in the area where there is plaque Intraoral photos using professional camera were taken for all teeth and all surfaces to record the plaque score.
- gingival inflammation was recorded using gingival index at six sites per tooth (distobuccal, midbuccal, mesiobuccal, distolingual/palatal, midlingual/palatal, mesiolingual/palatal) as follows : 0= Normal gingiva.
- Mild inflammation - slight change in colour and slight edema but no bleeding on probing.
- Moderate inflammation - redness, edema and glazing, bleeding on probing.
- Severe inflammation - marked redness and edema, ulceration with tendency for spontaneous bleeding. 3.Visual Analog Scale (VAS) visual analog scale from 0 - 10 (0 - unsatisfied, uncomfortable, or difficult to use, 10 -very satisfied, comfortable, and easy to use) in each visit was taken. Randomization and Blinding Independent of the clinical assessment, a third-party dentist used a computer-generated random number sequence to determine which side of each patient's mouth will be cleaned by interdental brush and which side will be cleaned by the oral irrigator. While participants were aware of which device they were using on each side, the examiner who performed the clinical examinations was blinded.
- Adverse events monitoring: Participants were monitored for adverse events during the study period such as gingival trauma, sensitivity, recession, tooth or restoration damage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth randomized controlled clincal trial, where each participant receives one interdental cleaning method for the right side, and another one for the left side.
| Arm | Type | Receives |
|---|---|---|
| Interdental brush | Experimental | Device: Interdental brushParticipants used an interdental brush twice daily for interdental cleaning on the assigned side |
| Water Flosser | Experimental | Device: Water flossParticipants used a water flosser twice daily for interdental cleaning on the other assigned side |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with fixed orthodontic appliance upper and lower arches.
- Patients with healthy gingiva with no periodontal disease.
- Patient's orthodontic plan doesn't require extraction of any teeth during the study period.
- Patients should have at least 26 teeth.
- Patients are motivated and able to clean their teeth.
Key exclusion criteria (4 listed)
- Smokers.
- Medically compromised patients.
- Pregnant woman.
- Using mouth wash or antibiotic in last 3 months.
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 |
|---|---|---|
| Interdental brushParticipants used an interdental brush twice daily after toothbrushing on the assigned side. This method was compared to the use of water floss in the contralateral side (split-mouth design). | Device | Interdental brush |
| Water flossParticipants used a water flosser twice daily after toothbrushing on the assigned side. Standard pressure setting and specialized tip were used. This method was compared to the use of an interdental brush in the contralateral quadrants (split-mouth design). | Device | Water Flosser |
Primary outcome
Plaque Index
Time frame: Baseline, 2 weeks, 4 weeks, 2 month and 3 months
Plaque accumulation assessed using the Rustogi Modified Navy Plaque Index (RMNPI) on designated tooth surfaces in the sides assigned to interdental brush and water flosser. The tooth was divided into multiple zones as the following : Whole mouth: areas A,B,C,D,E,F,G and H. Marginal (gum line): areas A,B and C. Interproximal: areas D and F 0 score was given the area where there is no plaque. 1 score was given in the area where there is plaque The minimum plaque score per surface (buccal or lingual) is zero, and the maximum plaque score per surface is 8 Intraoral photos using professional camera were taken for all teeth and all surfaces to record the plaque score.
2 secondary outcomes
Gingival Index
Time frame: Baseline, 2 weeks, 4 weeks, 2 months ,and 3 months
Visual Analog Scale (VAS)
Time frame: 2 Weeks, 4 weeks, 2months, and 3months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data for plaque index (RMNPI), gingival index and patient-reported outcomes will be shared. Data will be stripped of all identifiers to protect participants privacy.
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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.
Lana Bader, DClinDent study director
Jordan University of Science and Technology
Reem Sami Abed Alhafez, DClinDent Perio study director
Jordan University of Science and Technology
Ahmad shawqi, MClinDent Perio principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdental brush and Water floss in people with Dental Plaque and Gingival Bleeding, run by King Abdullah University Hospital at 1 site in Jordan.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 11 Dec 2025. 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 Jordan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index (time frame: Baseline, 2 weeks, 4 weeks, 2 month and 3 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 11 Dec 2025.