Back to resultsa Randomized Clinical Trial Evaluating Plaque Removal Around Dental Implants
Primary Purpose
Peri Implantitis
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
dental interproximal brush
dental floss
Sponsored by
About this trial
This is an interventional prevention trial for Peri Implantitis focused on measuring plaque removal around dental implants
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Smokers
- Probing Depth 6 or > 6mm
- Non compliant patients and patients with severe systemic conditions
Sites / Locations
- University of Manitoba (Graduate Periodontics Clinic)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
group : implants and oral hygiene
implants and oral hygiene
Arm Description
dental floss
dental interproximal brush
Outcomes
Primary Outcome Measures
plaque index
plaque removal
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02091609
Brief Title
a Randomized Clinical Trial Evaluating Plaque Removal Around Dental Implants
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri Implantitis
Keywords
plaque removal around dental implants
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group : implants and oral hygiene
Arm Type
Experimental
Arm Description
dental floss
Arm Title
implants and oral hygiene
Arm Type
Experimental
Arm Description
dental interproximal brush
Intervention Type
Other
Intervention Name(s)
dental interproximal brush
Intervention Description
use of this to maintain oral hygiene
Intervention Type
Other
Intervention Name(s)
dental floss
Intervention Description
use of this to maintain oral hygiene
Primary Outcome Measure Information:
Title
plaque index
Description
plaque removal
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Smokers
Probing Depth 6 or > 6mm
Non compliant patients and patients with severe systemic conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
omonkhele gertrude nwachukwu, BDS MScDPH
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
reem atout, DDS,DipPerio
Organizational Affiliation
University of Manitoba
Official's Role
Study Director
Facility Information:
Facility Name
University of Manitoba (Graduate Periodontics Clinic)
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E OW2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19820738
Citation
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.
Results Reference
background
PubMed Identifier
19138177
Citation
Slot 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.
Results Reference
background
PubMed Identifier
3053787
Citation
Loos 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.
Results Reference
background
PubMed Identifier
2778083
Citation
Loos 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.
Results Reference
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a Randomized Clinical Trial Evaluating Plaque Removal Around Dental Implants
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