Peri Implant MucositisNCT07364916
Effect of Water Flossing on Gingival Inflammation Around Single Implants
A study testing Water flosser and Tooth brush and string floss in people with Peri Implant Mucositis, run by King Abdulaziz University.
Trial summary
This study aims to evaluate the effect of water floss in reversing peri- implant mucositis around dental implants Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri Implant Mucositis
- What is being tested?
- Water flosser and Tooth brush and string floss
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Medically cleared
- Have at least one implant-supported crown.
Who cannot join
- Smoking
- Any systemic or localized illness that would interfere with dental implant therapy
- On medications
- Pregnancy
- History of periodontitis/ or peri-implant disease
- Poor oral hygiene
- Probing depth is >5
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Water Flossing on Gingival Inflammation Around Single Implants: Randomized Clinical Trial
This study aims to evaluate the effect of water floss in reversing peri- implant mucositis around dental implants
Read the detailed description
Patients will be assigned for two clinical appointments, the first visit is for baseline charting, probing depth will be recorded on six sites per implant, using a standardized periodontal probe and the presence or absence of bleeding will be recorded. Disclosing tablets will be utilized to
Confirm the presence or absence of plaque around teeth and the implant. Patients (Group A) will be given a water floss, with verbal and written instructions to use the water floss, twice daily for 2 minutes, along with brushing, while Group B will be instructed to brush with a manual brush alone, twice daily for 2 minutes. After two weeks, in the second visit, the implant site is re-evaluated to monitor the outcomes.
- Conditions
- Peri Implant Mucositis
- Being tested
- Water flosser, Tooth brush and string floss
- Keywords
- Peri- implant, Mucositis, Water irrigation, Water flosser
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water flosserDevice
Water irrigation device
Tooth brush and string flossDevice
The control group will use the toothbrush and the regular string floss.
| Study group | Role | What they receive |
|---|---|---|
| Water flosser | Experimental | The use of a water flosser+ brushing around implants with mucositis Receives: Device: Water flosser |
| Control | Active comparator | Brushing and using the string floss. Receives: Device: Tooth brush and string floss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on Probing
The disappearance of bleeding upon probing with the University of North Carolina-15 mm (UNC-15) periodontal probe. It is done at the same time as probing the pocket depths. It is done at six sites per implant-presence of bleeding = 1, absence = 0 -at each site.
Measured: 2 and 4 weeks
Plaque Index of Silness and Loe
Score Description 0 No plaque 1 A thin film of plaque adhering to the free gingival margin and adjacent area of the implant; not visible to the naked eye but detectable by probe 2 Moderate accumulation of soft deposits visible to the naked eye within the gingival pocket and/or on the implant and gingival margin | 3 Abundant soft matter within the gingival pocket and/or on the implant and gingival margin |
Measured: 4 weeks
Secondary outcomes (1)
Probing Pocket Depths (PPD)
The PPD will be recorded at baseline visit using the UNC-15 periodontal probe, at 2 weeks, and at 4 weeks. Pocket depths around implants should usually be around 1-4 mm. Pockets that are deeper than 4 mm or are 4 mm or less but with bleeding will be recorded as abnormal.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri Implant MucositisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of implant patients will be randomly allocated to one of 2 interventions; one group will brush only. The other group will brush and use the water flosser around the implant with mucositis.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Jamjoom, BDS, MS., King Abdulaziz University
- Investigators
- Amal G Jamjoom, Principal investigator, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364916
- Sponsor's protocol ID
- 129-11-24
- Status last verified
- Jan 2026
- First submitted
- 13 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to de-identified individual participant data will be granted to qualified researchers who submit a scientifically sound proposal outlining the research objectives and planned analyses. Requests will be reviewed by the principal investigator to ensure alignment with the original study aims, ethical approval, and data protection requirements. Approved applicants will be required to sign a data use agreement prior to data release. Data will be provided in a secure, de-identified format and used solely for the approved purpose.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Water Flossing on Gingival Inflammation Around Single Implants: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07364916
- Acronym / sponsor ID
- 129-11-24
- Conditions
- Peri Implant Mucositis
- Keywords
- Peri- implant, Mucositis, Water irrigation, Water flosser
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Jan 2026 (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 study aims to evaluate the effect of water floss in reversing peri- implant mucositis around dental implants
Detailed description
Patients will be assigned for two clinical appointments, the first visit is for baseline charting, probing depth will be recorded on six sites per implant, using a standardized periodontal probe and the presence or absence of bleeding will be recorded. Disclosing tablets will be utilized to
Confirm the presence or absence of plaque around teeth and the implant. Patients (Group A) will be given a water floss, with verbal and written instructions to use the water floss, twice daily for 2 minutes, along with brushing, while Group B will be instructed to brush with a manual brush alone, twice daily for 2 minutes. After two weeks, in the second visit, the implant site is re-evaluated to monitor the outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups of implant patients will be randomly allocated to one of 2 interventions; one group will brush only. The other group will brush and use the water flosser around the implant with mucositis.
| Arm | Type | Receives |
|---|---|---|
| Water flosser | Experimental | Device: Water flosserThe use of a water flosser+ brushing around implants with mucositis |
| Control | Active comparator | Device: Tooth brush and string flossBrushing and using the string floss. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Medically cleared
- Have at least one implant-supported crown.
Key exclusion criteria (7 listed)
- Smoking
- Any systemic or localized illness that would interfere with dental implant therapy
- On medications
- Pregnancy
- History of periodontitis/ or peri-implant disease
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 flosserWater irrigation device | Device | Water flosser |
| Tooth brush and string flossThe control group will use the toothbrush and the regular string floss. | Device | Control |
Primary outcome
Bleeding on Probing
Time frame: 2 and 4 weeks
The disappearance of bleeding upon probing with the University of North Carolina-15 mm (UNC-15) periodontal probe. It is done at the same time as probing the pocket depths. It is done at six sites per implant-presence of bleeding = 1, absence = 0 -at each site.
Plaque Index of Silness and Loe
Time frame: 4 weeks
Score Description 0 No plaque 1 A thin film of plaque adhering to the free gingival margin and adjacent area of the implant; not visible to the naked eye but detectable by probe 2 Moderate accumulation of soft deposits visible to the naked eye within the gingival pocket and/or on the implant and gingival margin | 3 Abundant soft matter within the gingival pocket and/or on the implant and gingival margin |
1 secondary outcome
Probing Pocket Depths (PPD)
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes. Access to de-identified individual participant data will be granted to qualified researchers who submit a scientifically sound proposal outlining the research objectives and planned analyses. Requests will be reviewed by the principal investigator to ensure alignment with the original study aims, ethical approval, and data protection requirements. Approved applicants will be required to sign a data use agreement prior to data release. Data will be provided in a secure, de-identified format and used solely for the approved purpose.
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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.
Amal G Jamjoom principal investigator
King Abdulaziz University
Questions about this trial
What is this clinical trial studying?
A study testing Water flosser and Tooth brush and string floss in people with Peri Implant Mucositis, run by King Abdulaziz University.
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 7 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: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amal Jamjoom, BDS, MS (+966500190435, agjamjoom@kau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding on Probing (time frame: 2 and 4 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 23 Jan 2026.