Peri ImplantitisNCT02091609
a Randomized Clinical Trial Evaluating Plaque Removal Around Dental Implants
A study testing dental interproximal brush and dental floss in people with Peri Implantitis, run by University of Manitoba at 1 site in Canada.
Trial summary
This aim of this study is to compare different oral hygiene aids for the ability to remove plaque in patients who went through dental implant treatment and are currently on a maintenance program at the Graduate Periodontal Clinic, at the University of Manitoba, Faculty of Dentistry. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri Implantitis
- What is being tested?
- dental interproximal brush and dental floss
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Jun 2016
- 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
- Non smokers, with clinical probing depth around implants is less than or equal to 6mm and are currently maintained every 3 months at the graduate periodontal program
Who cannot join
- Smokers
- Probing Depth 6 or > 6mm
- Non compliant patients and patients with severe systemic conditions
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Manitoba (Graduate Periodontics Clinic)
Winnipeg, Manitoba, R3E OW2
About this study
Official title: Evaluation of Plaque Removal Using Different Plaque Control Therapies Around Single Crown Dental Implants and Splinted Implant Crowns in Patients Under 3 Months Maintenance;a Randomized Clinical Trial
This aim of this study is to compare different oral hygiene aids for the ability to remove plaque in patients who went through dental implant treatment and are currently on a maintenance program at the Graduate Periodontal Clinic, at the University of Manitoba, Faculty of Dentistry.
Read the detailed description
Home care and Oral hygiene regimes are as well an important aspect of short and long term dental implant survival and success. The investigators profession demands us to educate the patients about the risk of peri implantitis and peri mucositis in plaque infected dentitions. In periodontal patients the areas of most ineffective plaque removal are typically the palatal/lingual and interdental areas.
there is therefore a need to developing scientific evidence to form a framework for professionals to follow when educating patients about their home care.
- Conditions
- Peri Implantitis
- Being tested
- dental interproximal brush, dental floss
- Keywords
- plaque removal around dental implants
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental interproximal brushOther
use of this to maintain oral hygiene
dental flossOther
use of this to maintain oral hygiene
| Study group | Role | What they receive |
|---|---|---|
| group : implants and oral hygiene | Experimental | dental floss Receives: Other: dental floss |
| implants and oral hygiene | Experimental | dental interproximal brush Receives: Other: dental interproximal brush |
What is being measured
The primary outcome is the main question the study is designed to answer.
plaque index
plaque removal
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peri ImplantitisStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- omonkhele gertrude nwachukwu, BDS MScDPH, Principal investigator, University of Manitobareem atout, DDS,DipPerio, Study director, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091609
- Sponsor's protocol ID
- H2013:458
- Status last verified
- May 2015
- First submitted
- 12 Mar 2014
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rasines G. The use of interdental brushes along with toothbrushing removes most plaque. Evid Based Dent. 2009;10(3):74. doi: 10.1038/sj.ebd.6400666.
PubMed 19820738Slot DE, Dorfer CE, Van der Weijden GA. The efficacy of interdental brushes on plaque and parameters of periodontal inflammation: a systematic review. Int J Dent Hyg. 2008 Nov;6(4):253-64. doi: 10.1111/j.1601-5037.2008.00330.x.
PubMed 19138177Loos B, Claffey N, Egelberg J. Clinical and microbiological effects of root debridement in periodontal furcation pockets. J Clin Periodontol. 1988 Aug;15(7):453-63. doi: 10.1111/j.1600-051x.1988.tb01600.x.
PubMed 3053787Loos B, Nylund K, Claffey N, Egelberg J. Clinical effects of root debridement in molar and non-molar teeth. A 2-year follow-up. J Clin Periodontol. 1989 Sep;16(8):498-504. doi: 10.1111/j.1600-051x.1989.tb02326.x.
PubMed 2778083
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Plaque Removal Using Different Plaque Control Therapies Around Single Crown Dental Implants and Splinted Implant Crowns in Patients Under 3 Months Maintenance;a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02091609
- Acronym / sponsor ID
- H2013:458
- Conditions
- Peri Implantitis
- Keywords
- plaque removal around dental implants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 19 Mar 2014 (estimated)
- 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 aim of this study is to compare different oral hygiene aids for the ability to remove plaque in patients who went through dental implant treatment and are currently on a maintenance program at the Graduate Periodontal Clinic, at the University of Manitoba, Faculty of Dentistry.
Detailed description
Home care and Oral hygiene regimes are as well an important aspect of short and long term dental implant survival and success. The investigators profession demands us to educate the patients about the risk of peri implantitis and peri mucositis in plaque infected dentitions. In periodontal patients the areas of most ineffective plaque removal are typically the palatal/lingual and interdental areas.
there is therefore a need to developing scientific evidence to form a framework for professionals to follow when educating patients about their home care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group : implants and oral hygiene | Experimental | Other: dental flossdental floss |
| implants and oral hygiene | Experimental | Other: dental interproximal brushdental interproximal brush |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non smokers, with clinical probing depth around implants is less than or equal to 6mm and are currently maintained every 3 months at the graduate periodontal program
Key exclusion criteria (3 listed)
- Smokers
- Probing Depth 6 or > 6mm
- Non compliant patients and patients with severe systemic conditions
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 |
|---|---|---|
| dental interproximal brushuse of this to maintain oral hygiene | Other | implants and oral hygiene |
| dental flossuse of this to maintain oral hygiene | Other | group : implants and oral hygiene |
Primary outcome
plaque index
Time frame: one year
plaque removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Background: PubMed 19820738Rasines G. The use of interdental brushes along with toothbrushing removes most plaque. Evid Based Dent. 2009;10(3):74. doi: 10.1038/sj.ebd.6400666.
- Background: PubMed 19138177Slot DE, Dorfer CE, Van der Weijden GA. The efficacy of interdental brushes on plaque and parameters of periodontal inflammation: a systematic review. Int J Dent Hyg. 2008 Nov;6(4):253-64. doi: 10.1111/j.1601-5037.2008.00330.x.
- Background: PubMed 3053787Loos B, Claffey N, Egelberg J. Clinical and microbiological effects of root debridement in periodontal furcation pockets. J Clin Periodontol. 1988 Aug;15(7):453-63. doi: 10.1111/j.1600-051x.1988.tb01600.x.
- Background: PubMed 2778083Loos B, Nylund K, Claffey N, Egelberg J. Clinical effects of root debridement in molar and non-molar teeth. A 2-year follow-up. J Clin Periodontol. 1989 Sep;16(8):498-504. doi: 10.1111/j.1600-051x.1989.tb02326.x.
- 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.
omonkhele gertrude nwachukwu, BDS MScDPH principal investigator
University of Manitoba
reem atout, DDS,DipPerio study director
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental interproximal brush and dental floss in people with Peri Implantitis, 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Apr 2016. 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?
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?
plaque index (time frame: one year). 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 NCT02091609, which also lists 4 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 6 Apr 2016.