The Effect of Peri-implant Surgery and Chair-side Supportive Post Surgical Peri-implant Therapy
Primary Purpose
Periimplantitis, Peri-implant Mucositis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chitosan brush
Sponsored by
About this trial
This is an interventional treatment trial for Periimplantitis
Eligibility Criteria
Inclusion Criteria:
Overt peri-implantitis presenting at least one implant with;
- radiographic bone loss ≥ 2.0 mm
- bleeding on probing (BoP)
Main exclusion criteria:
- radiotherapy
- chemotherapy
- systemic long-term corticosteroid treatment
- pregnancy or nursing
- anatomical abnormalities
- history of previous treatment of peri-implantitis within 6 months after the screening
- American Society of Anesthesiologists (ASA) classification for assessing the fitness of patients before surgery > 2
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test
Control
Arm Description
Treatment/maintenance of implants postsurgically performed by the use of chitosan brushes
Treatment/maintenance of implants postsurgically performed by the use of titanium curettes
Outcomes
Primary Outcome Measures
Inflammation control
Absence/presence of bleeding on probing and deep peri-implant pockets
Secondary Outcome Measures
Progressive bone loss
Loss of attachment at the implant identified on radiographs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03421717
Brief Title
The Effect of Peri-implant Surgery and Chair-side Supportive Post Surgical Peri-implant Therapy
Official Title
The Effect of Peri-implant Surgery and Chair-side Supportive Post Surgical Peri-implant Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2012 (Actual)
Primary Completion Date
December 9, 2016 (Actual)
Study Completion Date
April 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Peri-implantitis is defined as inflammation in the mucosa surrounding an oral implant with loss of supporting bone. The goals of peri-implantitis treatment are to resolve inflammation and to arrest the progression of disease. It is important to systematically gather information on the effect of surgical peri-implant treatment and to assess different protocols regarding chair-side maintenance of peri-implant tissue after surgery
The aims of this clinical investigation are to evaluate the clinical, microbiological and radiographic outcomes of surgical treatment of peri-implantitis and to evaluate the efficacy of 2 supportive treatment protocols based on the use of titanium cyrettes or by the use of a flexible, biodegradable chitosan brush. Furthermore, to evaluate the impact of this therapy on selected biochemical markers associated with chronic inflammation and bone tissue destruction.
Detailed Description
Little is known about the effect of chair-side maintenance of dental implants after peri-implantitits surgery. Traditionally, the maintenance has been performed by titanium curettes to remove microbiological deposits from the submucosal area.
The Labrida biodegradable brush is a novel debridement device intended for use on dental implants. The concept of using a biodegradable material is related to the suggested problems with leaving remnants on the treated implant surface which would be negative from a bone regenerative aspect. The use of a flexible brush relates to the access problems when treating dental implants both related to the threads as well as due to the prosthetic supra construction hindering access for debridement with regular instruments developed for teeth. The material used in the brush will be Chitosan which is a natural polysaccharide, chitosan (poly-N-acetyl glucosaminoglycan), which is a nontoxic and bioabsorbable (REK-approval 2012/791 polymer).
H0: It is possible to maintain peri-implant health after surgical peri-implantitis treatment. There is no short- or long term clinical or radiographical differences between patients surgically treated for peri-implantitis maintained by the use of titanium cyrettes or with the Labrida brush in chair-side supportive care
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periimplantitis, Peri-implant Mucositis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
6 month after surgical intervention, the population is randomly assigned to two parallel groups, receiving one of two maintenance programs - use of titanium curettes or chitosan brushes. Randomization was performed by pulling notes test/control.
Masking
InvestigatorOutcomes Assessor
Masking Description
Maintenance treatment (test/control) was performed after the investigator left the room. Investigator did not have access to the registration forms where information regarding assignment (test/control) was noted
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test
Arm Type
Experimental
Arm Description
Treatment/maintenance of implants postsurgically performed by the use of chitosan brushes
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Treatment/maintenance of implants postsurgically performed by the use of titanium curettes
Intervention Type
Device
Intervention Name(s)
Chitosan brush
Other Intervention Name(s)
Titanium curettes
Intervention Description
If inflammation (Bleeding on probing) and deep pockets (4 mm or more) is present at the control - maintenance is performed according to allocation
Primary Outcome Measure Information:
Title
Inflammation control
Description
Absence/presence of bleeding on probing and deep peri-implant pockets
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Progressive bone loss
Description
Loss of attachment at the implant identified on radiographs
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Overt peri-implantitis presenting at least one implant with;
radiographic bone loss ≥ 2.0 mm
bleeding on probing (BoP)
Main exclusion criteria:
radiotherapy
chemotherapy
systemic long-term corticosteroid treatment
pregnancy or nursing
anatomical abnormalities
history of previous treatment of peri-implantitis within 6 months after the screening
American Society of Anesthesiologists (ASA) classification for assessing the fitness of patients before surgery > 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odd Carsten Koldsland, Ph.D
Organizational Affiliation
Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be handeled by the investigators treating the patients and collecting data
Learn more about this trial
The Effect of Peri-implant Surgery and Chair-side Supportive Post Surgical Peri-implant Therapy
We'll reach out to this number within 24 hrs