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Mechanical Treatment Peri-Implant Mucositis (MechTreatPiM)

Primary Purpose

Peri-implant Mucositis

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Ultrasonic debridement
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-implant Mucositis

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subject must be ≥ 20 years Subject must have one implant presenting PIM as defined according to the World Workshop 2017 criteria (presence of BoP and/or suppuration (SoP), without bone loss exceeding 0.5 mm beyond crestal bone level changes resulting from initial remodeling, regardless of PPD. In absence of baseline radiographs (i.e., 0-1 year after loading) a bone level of <2mm from the top of the intraosseous part of the implant is considered as the reference threshold) Cleansable prosthesis (an interproximal brush must be able to pass from side to side at interproximal aspects tangential to the peri-implant sulcus, and a brush has to be able to reach the buccal and palatal/lingual sulcus). No evidence of occlusal overload No cement remnants identified on radiographs or clinically Implant-supported fixed restoration inserted at least 6 months before patient enrolment and not interfering with assessment of clinical parameters at more than 3/6 sites Periodontally healthy subjects or treated periodontitis (no residual site with PPD ≥ 5 mm) Full-mouth plaque (FMPS) and bleeding (FMBS) score ≤ 20%¬¬¬¬¬¬¬ at screening visit Non-smokers or light-smokers (<10 cigarettes per day) Competent to give consent Exclusion Criteria: Previous radiotherapy, current use of chemotherapy, systemic long-term corticosteroid treatment Hematologic disorders Pregnant subjects Patients classified as > class 2 according to the ASA (American Society of Anesthesiologists) physical status classification No systemic antibiotic treatment within 3 months prior to intervention

Sites / Locations

  • Institute of Clinical Dentistry, Faculty of Dentistry, University of OsloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mechanical treatment arm + oral hygiene reinforcement

Oral hygiene reinforcement alone

Arm Description

Subjects receive oral hygiene reinforcement, and additionally submucosal instrumentation with ultrasonics with a plastic tip.

Subjects receive oral hygiene reinforcement, but do not receive submucosal instrumentation.

Outcomes

Primary Outcome Measures

Bleeding on probing (BoP) extent
Reduction in the extent of BoP as measured on six sites per implant

Secondary Outcome Measures

Peri-implant sulcus fluid (PISF) biomarkers
Biomarkers sampled at baseline, 3- and 6-months
Intraoral digital scan
Volumetric change of soft tissue following peri-implant mucositis treatment
Disease resolution
No BoP at any of the six probed sites at 6-month follow-up
Severity of BoP
Reduction in the severity of BoP (graded from 0-3) at 6 months
Probing pocket depth (PPD) reduction
Reduction in PPD at 6 months
Bone level changes
Changes in bone level as assessed by radiographs at baseline and 6-months
Onset of peri-implantitis
If peri-implantitis is diagnosed during or following the study, this will be reported. Peri-implantitis is defined as progressive bone loss identified by an increase of PPD changes or bone level changes.

Full Information

First Posted
December 8, 2022
Last Updated
May 8, 2023
Sponsor
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT05664425
Brief Title
Mechanical Treatment Peri-Implant Mucositis
Acronym
MechTreatPiM
Official Title
Mechanical Treatment of Peri-Implant Mucositis -the Effect of Submucosal Instrumentation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
February 20, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This two-arm, single-blinded, monocentric, controlled, randomised clinical study is designed to examine the effect of professional submucosal treatment by means of ultrasonics with plastic tip (test group), as compared to no professional submucosal instrumentation (control group), in the treatment of peri-implant mucositis (PIM). Both groups will have oral hygiene instruction/reinforcement (OHI) at baseline and repeated at 3 months. In the study, 50 participants will be enrolled (25 per group), with each patient contributing one implant with PIM. Peri-implant sulcus fluid (PISF) samples will be obtained at baseline, 3- and 6-months to analyse the change of relevant biomarkers over the course of PIM treatment. Intraoral scans will be performed at baseline, 3- and 6-months to analyse potential soft-tissue volumetric changes according to treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implant Mucositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallell group two-arm randomised study
Masking
Investigator
Masking Description
Investigator-blinded
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mechanical treatment arm + oral hygiene reinforcement
Arm Type
Experimental
Arm Description
Subjects receive oral hygiene reinforcement, and additionally submucosal instrumentation with ultrasonics with a plastic tip.
Arm Title
Oral hygiene reinforcement alone
Arm Type
No Intervention
Arm Description
Subjects receive oral hygiene reinforcement, but do not receive submucosal instrumentation.
Intervention Type
Device
Intervention Name(s)
Ultrasonic debridement
Intervention Description
Ultrasonic debridement with a plastic/teflon tip (2 minutes + 1 minute irrigation)
Primary Outcome Measure Information:
Title
Bleeding on probing (BoP) extent
Description
Reduction in the extent of BoP as measured on six sites per implant
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Peri-implant sulcus fluid (PISF) biomarkers
Description
Biomarkers sampled at baseline, 3- and 6-months
Time Frame
6 months
Title
Intraoral digital scan
Description
Volumetric change of soft tissue following peri-implant mucositis treatment
Time Frame
6 months
Title
Disease resolution
Description
No BoP at any of the six probed sites at 6-month follow-up
Time Frame
6 months
Title
Severity of BoP
Description
Reduction in the severity of BoP (graded from 0-3) at 6 months
Time Frame
6 months
Title
Probing pocket depth (PPD) reduction
Description
Reduction in PPD at 6 months
Time Frame
6 months
Title
Bone level changes
Description
Changes in bone level as assessed by radiographs at baseline and 6-months
Time Frame
6 months
Title
Onset of peri-implantitis
Description
If peri-implantitis is diagnosed during or following the study, this will be reported. Peri-implantitis is defined as progressive bone loss identified by an increase of PPD changes or bone level changes.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject must be ≥ 20 years Subject must have one implant presenting PIM as defined according to the World Workshop 2017 criteria (presence of BoP and/or suppuration (SoP), without bone loss exceeding 0.5 mm beyond crestal bone level changes resulting from initial remodeling, regardless of PPD. In absence of baseline radiographs (i.e., 0-1 year after loading) a bone level of <2mm from the top of the intraosseous part of the implant is considered as the reference threshold) Cleansable prosthesis (an interproximal brush must be able to pass from side to side at interproximal aspects tangential to the peri-implant sulcus, and a brush has to be able to reach the buccal and palatal/lingual sulcus). No evidence of occlusal overload No cement remnants identified on radiographs or clinically Implant-supported fixed restoration inserted at least 6 months before patient enrolment and not interfering with assessment of clinical parameters at more than 3/6 sites Periodontally healthy subjects or treated periodontitis (no residual site with PPD ≥ 5 mm) Full-mouth plaque (FMPS) and bleeding (FMBS) score ≤ 20%¬¬¬¬¬¬¬ at screening visit Non-smokers or light-smokers (<10 cigarettes per day) Competent to give consent Exclusion Criteria: Previous radiotherapy, current use of chemotherapy, systemic long-term corticosteroid treatment Hematologic disorders Pregnant subjects Patients classified as > class 2 according to the ASA (American Society of Anesthesiologists) physical status classification No systemic antibiotic treatment within 3 months prior to intervention
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

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be available for other researchers upon reasonable request and as long as in accordance with ethical committee and national GDPR rules.

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Mechanical Treatment Peri-Implant Mucositis

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