Gingival HealthNCT07054203
The Effects of Using Water Flosser Versus Interdental Brush on Gingival Health in Patients With Mandibular Bonded Retainer
A study testing Water Flosser and Interdental Brush in people with Gingival Health, run by Aga Khan University at 1 site in Pakistan.
Trial summary
This randomized controlled trial aimed to investigate and compare the effects of employing a water flosser versus an interdental brush on the gingival health of individuals with mandibular bonded retainers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gingival Health
- What is being tested?
- Water Flosser and Interdental Brush
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Jul 2024to 10 Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing fixed orthodontic treatment requiring bonded retention
- All patients who will sign the informed consent form
Who cannot join
- • Patients with systemic diseases or multiple co-morbid such as diabetes, blood dyscrasias, etc.
- Patients with any previous history of periodontal surgery
- Patients with uncontrolled periodontal disease
- Pregnant women or lactating mothers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Using Water Flosser Versus Interdental Brush on Gingival Health in Patients With Mandibular Bonded Retainer - A Randomized Controlled Trial
This randomized controlled trial aimed to investigate and compare the effects of employing a water flosser versus an interdental brush on the gingival health of individuals with mandibular bonded retainers. The study recognized the significance of oral hygiene for individuals with such retainers, as they can pose challenges in maintaining optimal gum health due to their intricate structure. Participants were randomly allocated to either the water flosser group or the interdental brush group, and their gingival health was monitored over the course of the trial.
By evaluating key indicators of gingival health, such as plaque accumulation, bleeding, and inflammation, this study sought to shed light on the relative effectiveness of these two oral hygiene methods. The project's findings are anticipated to provide crucial insights into the most suitable and efficacious approach for individuals with mandibular bonded retainers, ultimately contributing to improved oral health outcomes and enhanced patient care. This research not only addresses a practical concern in dental care but also contributes to the broader understanding of oral hygiene strategies for patients with specialized orthodontic devices.
Read the detailed description
After the removal of orthodontic appliances, retention is one of the most important aspects of orthodontic therapy Removable and fixed retainers are examples of retention appliances that have been introduced. Since their inception in 1970, bonded fixed retainers have become more popular. Fixed retainers have benefits of demanding minimal patient compliance, being unnoticeable, ensuring safe and efficient permanent retention. However; some disadvantages of fixed retainers have also been noted, including increased chair side time, technique sensitivity, possible detrimental effects on periodontal tissues, the risk for tooth displacement due to wire distortion and frequent bond failures. Fixed retainers have benefits of demanding minimal patient compliance, being unnoticeable, ensuring safe and efficient permanent retention. However; some disadvantages of fixed retainers have also been noted, including increased chair side time, technique sensitivity, possible detrimental effects on periodontal tissues, the risk for tooth displacement due to wire distortion and frequent bond failures.
Despite all the disadvantages of fixed retainers, this type of retainer has become increasingly popular and at the same time raises concerns among dentists about possible periodontal health issues. It is stated that fixed retainers are conducive for plaque retention which cause gingivitis and periodontitis. A study on fixed retainers also concluded that long-term fixed retainer wear leads to increased calculus accumulations, marginal recession, and probing depths. These effects are due to long-term tissue irritation caused by the fixed retainer and bacterial build up around it. Bonding of the retainer to each tooth may limit toothbrush access to interdental areas, decreasing the ability of floss to glide smoothly across the teeth, resulting in a decrease in overall oral hygiene maintenance of patients.
One of those cleaning devices is a water flosser, which is effective in cleaning inaccessible areas which present commonly in patients with fixed retainers and can be used to improve their gingival health. To the best of our knowledge, there has been no previous research on this subject. Therefore, the goal of this randomized controlled trial is to compare the effects of water flosser versus interdental brush in improving gingival health in patients with mandibular permanent retainers by detecting differences in debris accumulation, plaque and calculus formation, and signs of gingival inflammation such as gingival bleeding.
RATIONALE:
With the increasing usage of bonded retainers in orthodontic treatment, the concerns about their effects on periodontal health are also increasing.14 Fixed retainers' applications in orthodontics without proper interdental cleaning aids may result in inadequate oral hygiene. Therefore, it is crucial to determine effective aids that not only improve the periodontal health but also prove to be simple and efficient to use for the patients. Moreover, to the best of our knowledge, no previous study has compared the effects of water flosser and interdental brush usage on oral hygiene maintenance in patients with fixed bonded retainers. .
- Conditions
- Gingival Health
- Being tested
- Water Flosser, Interdental Brush
- Keywords
- fixed orthodontic treatment, gingival health, mandibular bonded retainer, water flosser, interdental brushes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water FlosserDevice
Participants in this Arm used a powered oral irrigator delivering a pulsed water stream at 50-90 psi. The intervention consisted of once-daily full-mouth irrigation, added to routine tooth brushing, for a duration of six months.
Interdental BrushDevice
Participants in this Arm used cylindrical, color-coded interdental brushes matched to individual embrasure sizes. The intervention involved once-daily cleaning of all interproximal spaces for six months, in addition to routine twice-daily tooth brushing.
| Study group | Role | What they receive |
|---|---|---|
| Water Flosser | Experimental | This arm assigns participants to a powered Water Flosser (e.g., Waterpik Aquarius) because hydrodynamic shear forces can penetrate subgingival niches. Each participant receives standardized instruction plus a live demonstration; they then perform once-daily full-mouth irrigation for six months in addition to conventional tooth-brushing. Receives: Device: Interdental Brush |
| Interdental Brush | Active comparator | Participants allocated to this arm receive Interdental Brushes matched to embrasure size. They are instructed to perform once-daily mechanical cleaning of every interproximal space for six months, again paired with twice-daily manual tooth-brushing Receives: Device: Water Flosser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean plaque scores
A randomized controlled trial will be carried out to compare the effects of water flosser versus interdental brush in improving gingival health in patients with mandibular permanent retainers by detecting differences in debris accumulation, plaque and calculus formation, and signs of gingival inflammation such as gingival bleeding. For this we will divide our study participants into two groups, they will be randomly allocated in Group 1: Water flosser or Group 2: Interdental brush. Both groups will undergo retention procedure as per standard protocol by bonding of retainer on lingual surfaces of lower teeth. Plaque scores will be measured thrice, once immediately after debonding followed by three months and six months after debonding using periodontal probe.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start14 Jul 2024
- Primary completion1 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival HealthStudies 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
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054203
- Sponsor's protocol ID
- 2023-8799-26054
- Status last verified
- Dec 2025
- First submitted
- 25 Jun 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared to retain patient confidentiality
Publications
Masood Z, Fida M, Sukhia RH. The effects of using water flosser versus interdental brush on gingival health in patients with mandibular bonded retainer - a randomized controlled trial. BMC Oral Health. 2026 May 9;26(1):1234. doi: 10.1186/s12903-026-08233-6.
PubMed 42106668
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using Water Flosser Versus Interdental Brush on Gingival Health in Patients With Mandibular Bonded Retainer - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07054203
- Acronym / sponsor ID
- 2023-8799-26054
- Conditions
- Gingival Health
- Keywords
- fixed orthodontic treatment, gingival health, mandibular bonded retainer, water flosser, interdental brushes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 14 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 8 Jul 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.
This randomized controlled trial aimed to investigate and compare the effects of employing a water flosser versus an interdental brush on the gingival health of individuals with mandibular bonded retainers. The study recognized the significance of oral hygiene for individuals with such retainers, as they can pose challenges in maintaining optimal gum health due to their intricate structure. Participants were randomly allocated to either the water flosser group or the interdental brush group, and their gingival health was monitored over the course of the trial.
By evaluating key indicators of gingival health, such as plaque accumulation, bleeding, and inflammation, this study sought to shed light on the relative effectiveness of these two oral hygiene methods. The project's findings are anticipated to provide crucial insights into the most suitable and efficacious approach for individuals with mandibular bonded retainers, ultimately contributing to improved oral health outcomes and enhanced patient care. This research not only addresses a practical concern in dental care but also contributes to the broader understanding of oral hygiene strategies for patients with specialized orthodontic devices.
Detailed description
After the removal of orthodontic appliances, retention is one of the most important aspects of orthodontic therapy Removable and fixed retainers are examples of retention appliances that have been introduced. Since their inception in 1970, bonded fixed retainers have become more popular. Fixed retainers have benefits of demanding minimal patient compliance, being unnoticeable, ensuring safe and efficient permanent retention. However; some disadvantages of fixed retainers have also been noted, including increased chair side time, technique sensitivity, possible detrimental effects on periodontal tissues, the risk for tooth displacement due to wire distortion and frequent bond failures. Fixed retainers have benefits of demanding minimal patient compliance, being unnoticeable, ensuring safe and efficient permanent retention. However; some disadvantages of fixed retainers have also been noted, including increased chair side time, technique sensitivity, possible detrimental effects on periodontal tissues, the risk for tooth displacement due to wire distortion and frequent bond failures.
Despite all the disadvantages of fixed retainers, this type of retainer has become increasingly popular and at the same time raises concerns among dentists about possible periodontal health issues. It is stated that fixed retainers are conducive for plaque retention which cause gingivitis and periodontitis. A study on fixed retainers also concluded that long-term fixed retainer wear leads to increased calculus accumulations, marginal recession, and probing depths. These effects are due to long-term tissue irritation caused by the fixed retainer and bacterial build up around it. Bonding of the retainer to each tooth may limit toothbrush access to interdental areas, decreasing the ability of floss to glide smoothly across the teeth, resulting in a decrease in overall oral hygiene maintenance of patients.
One of those cleaning devices is a water flosser, which is effective in cleaning inaccessible areas which present commonly in patients with fixed retainers and can be used to improve their gingival health. To the best of our knowledge, there has been no previous research on this subject. Therefore, the goal of this randomized controlled trial is to compare the effects of water flosser versus interdental brush in improving gingival health in patients with mandibular permanent retainers by detecting differences in debris accumulation, plaque and calculus formation, and signs of gingival inflammation such as gingival bleeding.
RATIONALE:
With the increasing usage of bonded retainers in orthodontic treatment, the concerns about their effects on periodontal health are also increasing.14 Fixed retainers' applications in orthodontics without proper interdental cleaning aids may result in inadequate oral hygiene. Therefore, it is crucial to determine effective aids that not only improve the periodontal health but also prove to be simple and efficient to use for the patients. Moreover, to the best of our knowledge, no previous study has compared the effects of water flosser and interdental brush usage on oral hygiene maintenance in patients with fixed bonded retainers. .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water Flosser | Experimental | Device: Interdental BrushThis arm assigns participants to a powered Water Flosser (e.g., Waterpik Aquarius) because hydrodynamic shear forces can penetrate subgingival niches. Each participant receives standardized instruction plus a live demonstration; they then perform once-daily full-mouth irrigation for six months in addition to conventional tooth-brushing. |
| Interdental Brush | Active comparator | Device: Water FlosserParticipants allocated to this arm receive Interdental Brushes matched to embrasure size. They are instructed to perform once-daily mechanical cleaning of every interproximal space for six months, again paired with twice-daily manual tooth-brushing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing fixed orthodontic treatment requiring bonded retention
- All patients who will sign the informed consent form
Key exclusion criteria (4 listed)
- • Patients with systemic diseases or multiple co-morbid such as diabetes, blood dyscrasias, etc.
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 |
|---|---|---|
| Water FlosserParticipants in this Arm used a powered oral irrigator delivering a pulsed water stream at 50-90 psi. The intervention consisted of once-daily full-mouth irrigation, added to routine tooth brushing, for a duration of six months. | Device | Interdental Brush |
| Interdental BrushParticipants in this Arm used cylindrical, color-coded interdental brushes matched to individual embrasure sizes. The intervention involved once-daily cleaning of all interproximal spaces for six months, in addition to routine twice-daily tooth brushing. | Device | Water Flosser |
Primary outcome
Mean plaque scores
Time frame: 6 months
A randomized controlled trial will be carried out to compare the effects of water flosser versus interdental brush in improving gingival health in patients with mandibular permanent retainers by detecting differences in debris accumulation, plaque and calculus formation, and signs of gingival inflammation such as gingival bleeding. For this we will divide our study participants into two groups, they will be randomly allocated in Group 1: Water flosser or Group 2: Interdental brush. Both groups will undergo retention procedure as per standard protocol by bonding of retainer on lingual surfaces of lower teeth. Plaque scores will be measured thrice, once immediately after debonding followed by three months and six months after debonding using periodontal probe.
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 23 Dec 2025.
- Derived from this study: PubMed 42106668Masood Z, Fida M, Sukhia RH. The effects of using water flosser versus interdental brush on gingival health in patients with mandibular bonded retainer - a randomized controlled trial. BMC Oral Health. 2026 May 9;26(1):1234. doi: 10.1186/s12903-026-08233-6.
- Individual participant dataSharing planned: No. No data will be shared to retain patient confidentiality
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Flosser and Interdental Brush in people with Gingival Health, run by Aga Khan University at 1 site in Pakistan.
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 2 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 23 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 Pakistan. 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?
Mean plaque scores (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07054203, which also lists 1 linked publication.
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 23 Dec 2025.