Back to resultsPeri-implantitis Implantoplasty Treatment
Primary Purpose
Peri-Implantitis, Peri-implant Mucositis
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Implantoplasty
Open flap debridement alone
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis
Eligibility Criteria
Inclusion Criteria:
- Peri-implantitis (according to 2018 criteria) on minimum 2 implants of similar surface and defect type
- Competent to give consent
- Exposed, modified implant surface with loss >2mm
Exclusion Criteria:
- Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
- Present or past use of bisphosphonate treatment • Pregnant or nursing subjects
- Patients classified as > class II according to ASA classification
- Implant unavailable for implantoplasty treatment
- Inhability to comprehend and respond to the quality of life questionnaire
- Examiners/operators deem original placement of implant (angle, position) suboptimal and considered to play a major role in development of peri-implantitis
- History of peri-implantitis surgery prior to 6 months of screening
Sites / Locations
- Institute of Clinical Dentistry, Faculty of Dentistry, University of OsloRecruiting
- Institute of Clinical Dentistry, University of Oslo, NorwayRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Peri-implantitis treatment with implantoplasty
Peri-implantitis treatment without implantoplasty
Arm Description
Open flap debridement with implantoplasty treatment
Open flap debridement withput implantoplasty treatment
Outcomes
Primary Outcome Measures
Bleeding on probing
Measured with a periodontal probe
Bleeding on probing
Measured with a periodontal probe
Secondary Outcome Measures
Suppuration
Visible suppuration upon probing the implant with a periodontal probe
Suppuration
Visible suppuration upon probing the implant with a periodontal probe
Pocket probing depth
Measured with a periodontal probe
Pocket probing depth
Measured with a periodontal probe
Changes in patient-reported quality of life (QoL)
To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected; (2) less than once a month; (3) once or twice a month; (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome.
Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected; including category (1)
Clinical attachment loss measurements
Measured with a periodontal probe
Clinical attachment loss measurements
Measured with a periodontal probe
Radiographic bone loss
Measured on standardized radiograps
Radiographic bone loss
Measured on standardized radiograps
Implant fracture
Clinical examination to assess whether implants have fractured following treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04052373
Brief Title
Peri-implantitis Implantoplasty Treatment
Official Title
Surgical Peri-implantitis Treatment With and Without Implantoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
June 15, 2027 (Anticipated)
Study Completion Date
June 15, 2027 (Anticipated)
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
5. Study Description
Brief Summary
This double arm, split-mouth, single centre, controlled, randomised clinical study is designed to examine the effect of implantoplasty in treatment of peri-implantitis.
Peri-implantitis will be treated with open flap debridement, with or without implantoplasty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis, Peri-implant Mucositis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peri-implantitis treatment with implantoplasty
Arm Type
Experimental
Arm Description
Open flap debridement with implantoplasty treatment
Arm Title
Peri-implantitis treatment without implantoplasty
Arm Type
Active Comparator
Arm Description
Open flap debridement withput implantoplasty treatment
Intervention Type
Procedure
Intervention Name(s)
Implantoplasty
Intervention Description
Implantoplasty is the mechanical smoothening of rough titanium implants as part of the surgical treatment of peri-implantitis. Treatment is thought to facilitate self-performed oral hygiene.
Intervention Type
Procedure
Intervention Name(s)
Open flap debridement alone
Intervention Description
Open flap debridement alone
Primary Outcome Measure Information:
Title
Bleeding on probing
Description
Measured with a periodontal probe
Time Frame
12 months after treatment
Title
Bleeding on probing
Description
Measured with a periodontal probe
Time Frame
24 months after treatment
Secondary Outcome Measure Information:
Title
Suppuration
Description
Visible suppuration upon probing the implant with a periodontal probe
Time Frame
12 months after treatment
Title
Suppuration
Description
Visible suppuration upon probing the implant with a periodontal probe
Time Frame
24 months after treatment
Title
Pocket probing depth
Description
Measured with a periodontal probe
Time Frame
12 months after treatment
Title
Pocket probing depth
Description
Measured with a periodontal probe
Time Frame
24 months after treatment
Title
Changes in patient-reported quality of life (QoL)
Description
To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected; (2) less than once a month; (3) once or twice a month; (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome.
Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected; including category (1)
Time Frame
Preoperatively compared to 24 months after treatment
Title
Clinical attachment loss measurements
Description
Measured with a periodontal probe
Time Frame
12 months after treatment
Title
Clinical attachment loss measurements
Description
Measured with a periodontal probe
Time Frame
24 months after treatment
Title
Radiographic bone loss
Description
Measured on standardized radiograps
Time Frame
12 months after treatment
Title
Radiographic bone loss
Description
Measured on standardized radiograps
Time Frame
24 months after treatment
Title
Implant fracture
Description
Clinical examination to assess whether implants have fractured following treatment
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Peri-implantitis (according to 2018 criteria) on minimum 2 implants of similar surface and defect type
Competent to give consent
Exposed, modified implant surface with loss >2mm
Exclusion Criteria:
Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
Present or past use of bisphosphonate treatment • Pregnant or nursing subjects
Patients classified as > class II according to ASA classification
Implant unavailable for implantoplasty treatment
Inhability to comprehend and respond to the quality of life questionnaire
Examiners/operators deem original placement of implant (angle, position) suboptimal and considered to play a major role in development of peri-implantitis
History of peri-implantitis surgery prior to 6 months of screening
Facility Information:
Facility Name
Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo
City
Oslo
ZIP/Postal Code
0455
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Verket, PhD
Phone
+47 93667661
Email
anderver@odont.uio.no
First Name & Middle Initial & Last Name & Degree
Odd Koldsland, PhD
Phone
+47 93098618
Email
oddcko@odont.uio.no
Facility Name
Institute of Clinical Dentistry, University of Oslo, Norway
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Verket, PhD
Phone
+47 22852064
Email
anderver@odont.uio.no
12. IPD Sharing Statement
Learn more about this trial
Peri-implantitis Implantoplasty Treatment
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