Implant Site BleedingNCT04081311
A Comparison of the Efficacy of Interdental Floss to Water Flosser Around Dental Implants
A study testing comparing interdental floss to water flosser around dental implants in people with Implant Site Bleeding, run by University of Manitoba at 1 site in Canada.
Trial summary
The primary objective of this study was to compare two different interproximal devices, water flosser and dental floss around implants in several clinical parameters Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Site Bleeding
- What is being tested?
- comparing interdental floss to water flosser around dental implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 6 Sep 2019to 31 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients that present with at least a single implant with a screw-retained crown
- Patients with general good health that do not have a condition contra-indicating routine dental treatment
- Patients that are compliant with the research protocol and methods
- Patients that have read, understood and signed the informed consent form
Who cannot join
- Patients with implants with cemented crowns
- Patients with any contact hypersensitivity to the related materials used in the study
- Tobacco users (vaping included)
- Patients unwilling to sign the informed consent form or follow the protocol of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Efficacy of Interdental Floss to Water Flosser Around Dental Implants in Maintenance Patients: a Randomized Controlled Trial
The primary objective of this study was to compare two different interproximal devices, water flosser and dental floss around implants in several clinical parameters
Read the detailed description
This study was a randomized, controlled clinical trial in a single center. All clinical measurements were taken by a single blinded investigator (Periodontal Resident) while a single dental hygienist was responsible for prophylaxis and delivery of oral hygiene instructions to the study participants. At each appointment 5 clinical parameters were recorded: Full Mouth Plaque Score (FMPS) and Quigley-Hein plaque index (QHI) of the implants after the use of a disclosing solution, Probing Depth (PD), Bleeding on Probing (BOP) of the study implants recorded at 6 sites (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual and mesiolingual) using a UNC 12 Colorvue probe and the width of the keratinized tissue (KT) at the buccal surface of the study implants. Randomization between the 2 groups was achieved using computerized randomization scheme (https://en.calc-site.com/randoms/grouping).
Group A (control): patients were instructed to floss with TePe Bridge and Implant Floss once a day, preferably at nighttime.
Group B (test): patients were provided with Waterpik Water Flosser and instructed to water floss around the implant once a day, preferably at nighttime.
During each appointment the study investigator measured clinical parameters and participants received oral hygiene instructions (OHI) and supportive periodontal therapy (SPT) by a single dental hygienist. Once the study was concluded patients were asked to fill-out a 2 question questionnaire inquiring how much they liked their interproximal device and how easy it was to be used in a scale 1 to 5.
- Conditions
- Implant Site Bleeding
- Being tested
- comparing interdental floss to water flosser around dental implants
- Keywords
- dental implants, water flosser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparing interdental floss to water flosser around dental implantsDevice
to determine the effectiveness in reducing the bleeding on probing (BOP) index around dental implants
| Study group | Role | What they receive |
|---|---|---|
| water flosser | Experimental | patient will be provided with Waterpik Water Flosser and instructed to water floss around the implant once a day, preferably at nighttime Receives: Device: comparing interdental floss to water flosser around dental implants |
| dental floss | Active comparator | patient will be instructed to floss with TePe Bridge and Implant Floss once a day, preferably at nighttime Receives: Device: comparing interdental floss to water flosser around dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BOP (bleeding on probing) index around dental implants
to determine the effectiveness of a waterfloss system compared to flossing in changing the bleeding on probing (BOP) index around dental implants. BOP is a sign of inflammation and is recorded as yes/no (yes for bleeding, no for absence of bleeding). BOP is a percentage calculated by dividing the number of bleeding sites divided by the total number of sites of each implant. A lower percentage indicates lower inflammation
Measured: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
Full Mouth Plaque Score (FMPS)
to determine the differences between water flosser compared to flossing in changing the Full Mouth Plaque Score (FMPS). FMPS is a percentage calculated by dividing the number of plaque containing surfaces divided by the total number of available surfaces of each tooth/implant. A lower percentage indicates lower total plaque and means better plaque control
Measured: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
Quigley-Hein plaque index (QHI) around dental implants
to determine the differences of a waterfloss system compared to flossing in (QHI) around dental implants. Quigley-Hein plaque index (QHI) is a scale 0 to 5.
0 no plaque.
- separate flecks of plaque at the cervical margin of the tooth.
- a thin continuous band of plaque (up to one mm) at the cervical margin of the tooth.
- a band of plaque wider than one mm but covering less than one-third of the crown of the tooth.
- plaque covering at least one-third but less than two-thirds of the crown of the tooth.
- plaque covering two-thirds or more of the crown of the tooth.
A lower number indicates better plaque control.
Measured: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
keratinized tissue (KT) around dental implants
to evaluate the differences of a waterfloss system compared to flossing in the width of keratinized tissue (KT) around dental implants. KT is the stratified, squamous epithelium, that lines the vestibular and oral surfaces of the gingiva.
Measured: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
Probing Depth (PD) around dental implants
to evaluate the differences of a waterfloss system compared to flossing in Probing Depth (PD) around dental implants. PD is the measurement of the depth of a sulcus by measuring in millimeters the distance from a gingival margin to the base of the sulcus with a calibrated periodontal probe.
Measured: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start6 Sep 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Implant Site BleedingStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Model description
- Randomized, controlled clinical trial in a single center.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081311
- Sponsor's protocol ID
- H2019:298
- Status last verified
- Apr 2021
- First submitted
- 4 Sep 2019
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Testori T, Del Fabbro M, Feldman S, Vincenzi G, Sullivan D, Rossi R Jr, Anitua E, Bianchi F, Francetti L, Weinstein RL. A multicenter prospective evaluation of 2-months loaded Osseotite implants placed in the posterior jaws: 3-year follow-up results. Clin Oral Implants Res. 2002 Apr;13(2):154-61. doi: 10.1034/j.1600-0501.2002.130205.x.
PubMed 11952735van Velzen FJ, Lang NP, Schulten EA, Ten Bruggenkate CM. Dental floss as a possible risk for the development of peri-implant disease: an observational study of 10 cases. Clin Oral Implants Res. 2016 May;27(5):618-21. doi: 10.1111/clr.12650. Epub 2015 Aug 11.
PubMed 26261052Montevecchi M, De Blasi V, Checchi L. Is Implant Flossing a Risk-Free Procedure? A Case Report with a 6-year Follow-up. Int J Oral Maxillofac Implants. 2016 May-Jun;31(3):e79-83. doi: 10.11607/jomi.4263.
PubMed 27183086Worthington HV, MacDonald L, Poklepovic Pericic T, Sambunjak D, Johnson TM, Imai P, Clarkson JE. Home use of interdental cleaning devices, in addition to toothbrushing, for preventing and controlling periodontal diseases and dental caries. Cochrane Database Syst Rev. 2019 Apr 10;4(4):CD012018. doi: 10.1002/14651858.CD012018.pub2.
PubMed 30968949Kelekis-Cholakis A, Rothney J. Maintenance of Implant Patients: A Narrative Review. Implant Dent. 2019 Apr;28(2):161-172. doi: 10.1097/ID.0000000000000837.
PubMed 30601226Magnuson B, Harsono M, Stark PC, Lyle D, Kugel G, Perry R. Comparison of the effect of two interdental cleaning devices around implants on the reduction of bleeding: a 30-day randomized clinical trial. Compend Contin Educ Dent. 2013 Nov-Dec;34 Spec No 8:2-7.
PubMed 24568169
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Efficacy of Interdental Floss to Water Flosser Around Dental Implants in Maintenance Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04081311
- Acronym / sponsor ID
- H2019:298
- Conditions
- Implant Site Bleeding
- Keywords
- dental implants, water flosser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 9 Sep 2019 (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 primary objective of this study was to compare two different interproximal devices, water flosser and dental floss around implants in several clinical parameters
Detailed description
This study was a randomized, controlled clinical trial in a single center. All clinical measurements were taken by a single blinded investigator (Periodontal Resident) while a single dental hygienist was responsible for prophylaxis and delivery of oral hygiene instructions to the study participants. At each appointment 5 clinical parameters were recorded: Full Mouth Plaque Score (FMPS) and Quigley-Hein plaque index (QHI) of the implants after the use of a disclosing solution, Probing Depth (PD), Bleeding on Probing (BOP) of the study implants recorded at 6 sites (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual and mesiolingual) using a UNC 12 Colorvue probe and the width of the keratinized tissue (KT) at the buccal surface of the study implants. Randomization between the 2 groups was achieved using computerized randomization scheme (https://en.calc-site.com/randoms/grouping).
Group A (control): patients were instructed to floss with TePe Bridge and Implant Floss once a day, preferably at nighttime.
Group B (test): patients were provided with Waterpik Water Flosser and instructed to water floss around the implant once a day, preferably at nighttime.
During each appointment the study investigator measured clinical parameters and participants received oral hygiene instructions (OHI) and supportive periodontal therapy (SPT) by a single dental hygienist. Once the study was concluded patients were asked to fill-out a 2 question questionnaire inquiring how much they liked their interproximal device and how easy it was to be used in a scale 1 to 5.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized, controlled clinical trial in a single center.
| Arm | Type | Receives |
|---|---|---|
| water flosser | Experimental | Device: comparing interdental floss to water flosser around dental implantspatient will be provided with Waterpik Water Flosser and instructed to water floss around the implant once a day, preferably at nighttime |
| dental floss | Active comparator | Device: comparing interdental floss to water flosser around dental implantspatient will be instructed to floss with TePe Bridge and Implant Floss once a day, preferably at nighttime |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients that present with at least a single implant with a screw-retained crown
- Patients with general good health that do not have a condition contra-indicating routine dental treatment
- Patients that are compliant with the research protocol and methods
- Patients that have read, understood and signed the informed consent form
Key exclusion criteria (4 listed)
- Patients with implants with cemented crowns
- Patients with any contact hypersensitivity to the related materials used in the study
- Tobacco users (vaping included)
- Patients unwilling to sign the informed consent form or follow the protocol of 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 |
|---|---|---|
| comparing interdental floss to water flosser around dental implantsto determine the effectiveness in reducing the bleeding on probing (BOP) index around dental implants | Device | dental floss, water flosser |
Primary outcome
Change in BOP (bleeding on probing) index around dental implants
Time frame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
to determine the effectiveness of a waterfloss system compared to flossing in changing the bleeding on probing (BOP) index around dental implants. BOP is a sign of inflammation and is recorded as yes/no (yes for bleeding, no for absence of bleeding). BOP is a percentage calculated by dividing the number of bleeding sites divided by the total number of sites of each implant. A lower percentage indicates lower inflammation
Full Mouth Plaque Score (FMPS)
Time frame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
to determine the differences between water flosser compared to flossing in changing the Full Mouth Plaque Score (FMPS). FMPS is a percentage calculated by dividing the number of plaque containing surfaces divided by the total number of available surfaces of each tooth/implant. A lower percentage indicates lower total plaque and means better plaque control
Quigley-Hein plaque index (QHI) around dental implants
Time frame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
to determine the differences of a waterfloss system compared to flossing in (QHI) around dental implants. Quigley-Hein plaque index (QHI) is a scale 0 to 5. 0 no plaque. 1. separate flecks of plaque at the cervical margin of the tooth. 2. a thin continuous band of plaque (up to one mm) at the cervical margin of the tooth. 3. a band of plaque wider than one mm but covering less than one-third of the crown of the tooth. 4. plaque covering at least one-third but less than two-thirds of the crown of the tooth. 5. plaque covering two-thirds or more of the crown of the tooth. A lower number indicates better plaque control.
keratinized tissue (KT) around dental implants
Time frame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
to evaluate the differences of a waterfloss system compared to flossing in the width of keratinized tissue (KT) around dental implants. KT is the stratified, squamous epithelium, that lines the vestibular and oral surfaces of the gingiva.
Probing Depth (PD) around dental implants
Time frame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)
to evaluate the differences of a waterfloss system compared to flossing in Probing Depth (PD) around dental implants. PD is the measurement of the depth of a sulcus by measuring in millimeters the distance from a gingival margin to the base of the sulcus with a calibrated 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 30 Apr 2021.
- Background: PubMed 11952735Testori T, Del Fabbro M, Feldman S, Vincenzi G, Sullivan D, Rossi R Jr, Anitua E, Bianchi F, Francetti L, Weinstein RL. A multicenter prospective evaluation of 2-months loaded Osseotite implants placed in the posterior jaws: 3-year follow-up results. Clin Oral Implants Res. 2002 Apr;13(2):154-61. doi: 10.1034/j.1600-0501.2002.130205.x.
- Background: PubMed 26261052van Velzen FJ, Lang NP, Schulten EA, Ten Bruggenkate CM. Dental floss as a possible risk for the development of peri-implant disease: an observational study of 10 cases. Clin Oral Implants Res. 2016 May;27(5):618-21. doi: 10.1111/clr.12650. Epub 2015 Aug 11.
- Background: PubMed 27183086Montevecchi M, De Blasi V, Checchi L. Is Implant Flossing a Risk-Free Procedure? A Case Report with a 6-year Follow-up. Int J Oral Maxillofac Implants. 2016 May-Jun;31(3):e79-83. doi: 10.11607/jomi.4263.
- Background: PubMed 30968949Worthington HV, MacDonald L, Poklepovic Pericic T, Sambunjak D, Johnson TM, Imai P, Clarkson JE. Home use of interdental cleaning devices, in addition to toothbrushing, for preventing and controlling periodontal diseases and dental caries. Cochrane Database Syst Rev. 2019 Apr 10;4(4):CD012018. doi: 10.1002/14651858.CD012018.pub2.
- Background: PubMed 30601226Kelekis-Cholakis A, Rothney J. Maintenance of Implant Patients: A Narrative Review. Implant Dent. 2019 Apr;28(2):161-172. doi: 10.1097/ID.0000000000000837.
- Background: PubMed 24568169Magnuson B, Harsono M, Stark PC, Lyle D, Kugel G, Perry R. Comparison of the effect of two interdental cleaning devices around implants on the reduction of bleeding: a 30-day randomized clinical trial. Compend Contin Educ Dent. 2013 Nov-Dec;34 Spec No 8:2-7.
- 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.
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 comparing interdental floss to water flosser around dental implants in people with Implant Site Bleeding, run by University of Manitoba at 1 site in Canada.
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 4 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 30 Apr 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 Canada. 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?
Change in BOP (bleeding on probing) index around dental implants (time frame: All participants have been seen at baseline, follow-up 1 (interval ranging between 3 to 6 months)). The study lists 5 primary outcomes in all. 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 NCT04081311, which also lists 6 linked publications.
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 30 Apr 2021.