Peri-implant MucositisNCT04462341
Efficacy of an Oral Hygiene Implant Protocol
A study testing Water Flosser and Manual Toothbrush in people with Peri-implant Mucositis, run by Water Pik, Inc. at 1 site in United States.
Trial summary
This study is designed to evaluate the effectiveness of cleaning around implants that hold a full denture in the mouth. Different oral hygiene protocols will be compared. Areas to measure are gum tissue color and consistency, bleeding and cleanliness. A questionnaire will be provided at the end of the study. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Water Flosser and Manual Toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 1 Jun 2021
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have a maxillary and/or mandibular implant supported, removable complete denture that is supported by at least 2 implants in good, serviceable condition
- Good general health, with no diseases which could impact periodontal health
- able to read and understand English
- willing to return for all appointments
- at least 30% BOP
- probing depths less or equal to 5mm
Who cannot join
- subjects who are currently pregnant
- mobility of implant
- subjects who have diabetes
- subjects who smoke
- subjects with any serious medical condition which the investigator feels may impact participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts School of Dental Medicine
Boston, Massachusetts, 02111
About this study
Official title: Efficacy of an Oral Hygiene Regimen on Implant Supported, Removable Complete Denture: Effect on Gingival Tissue and Prosthesis: A Proof of Concept Study
This study is designed to evaluate the effectiveness of cleaning around implants that hold a full denture in the mouth. Different oral hygiene protocols will be compared. Areas to measure are gum tissue color and consistency, bleeding and cleanliness. A questionnaire will be provided at the end of the study. This is a proof of concept study.
Read the detailed description
The aim of this proof of concept study is to evaluate the effect of an oral hygiene regimen of manual brushing and water flossing on implant retained removable complete dentures. This is a randomized, two arm clinical trial that will compare the traditional oral hygiene regimen to the experimental regimen. Data will be evaluated at baseline, 3 weeks and 6 weeks. Photographs of the tissue and denture will be taken.
- Conditions
- Peri-implant Mucositis
- Being tested
- Water Flosser, Manual Toothbrush
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water FlosserDevice
Device that uses water under pressure to clean around teeth and under the gums
Manual ToothbrushDevice
Plastic handle with nylon bristles to clean teeth
| Study group | Role | What they receive |
|---|---|---|
| Manual brushing only | Active comparator | Participants brushed with a manual toothbrush and fluoridated toothpaste twice a day for 6 weeks Receives: Device: Manual Toothbrush |
| Manual brushing + water flossing | Experimental | Participants brush twice a day and water flossed once a day for 6 weeks. Receives: Device: Water Flosser; Device: Manual Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on probing
Binary
Measured: 6 weeks
Secondary outcomes (1)
Probing depth
mm
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start7 Jan 2019
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Why it stopped: COVID-19
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Water Pik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Kugel, DDS, Study chair, Tufts School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462341
- Sponsor's protocol ID
- 29DRIOH2019
- Status last verified
- Jul 2020
- First submitted
- 2 Jul 2020
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Oral Hygiene Regimen on Implant Supported, Removable Complete Denture: Effect on Gingival Tissue and Prosthesis: A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT04462341
- Acronym / sponsor ID
- 29DRIOH2019
- Conditions
- Peri-implant Mucositis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Water Pik, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 8 Jul 2020 (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 is designed to evaluate the effectiveness of cleaning around implants that hold a full denture in the mouth. Different oral hygiene protocols will be compared. Areas to measure are gum tissue color and consistency, bleeding and cleanliness. A questionnaire will be provided at the end of the study. This is a proof of concept study.
Detailed description
The aim of this proof of concept study is to evaluate the effect of an oral hygiene regimen of manual brushing and water flossing on implant retained removable complete dentures. This is a randomized, two arm clinical trial that will compare the traditional oral hygiene regimen to the experimental regimen. Data will be evaluated at baseline, 3 weeks and 6 weeks. Photographs of the tissue and denture will be taken.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual brushing only | Active comparator | Device: Manual ToothbrushParticipants brushed with a manual toothbrush and fluoridated toothpaste twice a day for 6 weeks |
| Manual brushing + water flossing | Experimental | Device: Water Flosser, Device: Manual ToothbrushParticipants brush twice a day and water flossed once a day for 6 weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- have a maxillary and/or mandibular implant supported, removable complete denture that is supported by at least 2 implants in good, serviceable condition
- Good general health, with no diseases which could impact periodontal health
- able to read and understand English
- willing to return for all appointments
- at least 30% BOP
Key exclusion criteria (5 listed)
- subjects who are currently pregnant
- mobility of implant
- subjects who have diabetes
- subjects who smoke
- subjects with any serious medical condition which the investigator feels may impact participation in the study
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 FlosserDevice that uses water under pressure to clean around teeth and under the gums | Device | Manual brushing + water flossing |
| Manual ToothbrushPlastic handle with nylon bristles to clean teeth | Device | Manual brushing + water flossing, Manual brushing only |
Primary outcome
Bleeding on probing
Time frame: 6 weeks
Binary
1 secondary outcome
Probing depth
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
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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.
Gerard Kugel, DDS study chair
Tufts School of Dental Medicine
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 Manual Toothbrush in people with Peri-implant Mucositis, run by Water Pik, Inc. at 1 site in United States.
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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 27 Aug 2021. 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 United States. 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 was stopped early (reason given: COVID-19). Results are not available in the source record.
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?
Bleeding on probing (time frame: 6 weeks). 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 27 Aug 2021.