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Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing

Primary Purpose

Periimplantitis

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
erythritol jet
Manual instrumentation
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periimplantitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: At least 1 osseointegrated implant diagnosed with peri-implantitis (according to the new Classification of Periodontal and Peri-implant Diseases and Conditions) and rehabilitated with screw-retained crown Patients of legal age (≥18 years old) Exclusion Criteria: Uncontrolled systemic pathologies, namely diabetes mellitus (HbA1c > 7% or >53 mmol/mol) Pregnant or lactating patients Severe smoking (>20 cigarettes/day) Systemic pathologies, medication or treatments that cause alterations in bone metabolism (for example: osteoporosis, bisphosphonates, radiotherapy of the head and neck) Patients who missed study control visits Patients who have received systemic antibiotic therapy in the last 2 months Patients with allergies to any of the components used in the study, namely to erythritol Implants that have previously undergone surgical treatment for peri-implantitis Implants with bone loss greater than 2/3 of their length and/or mobility

Sites / Locations

  • Faculty of Dentistry at the University of OPortoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

erythritol jet (EMS)

Manual instrumentation

Arm Description

An erythritol jet (Perioflow from EMS) will be used to debride the periodontal pockets of oral implants diagnosed with per-implantitis.

An ultrasonic handpiece will be used to debride the periodontal pockets of oral implants diagnosed with per-implantitis.

Outcomes

Primary Outcome Measures

Change in probing pocket depth
The distance measured from the base of the sulcus or pocket to the free gingival margin at six points per implant (measured in millimetres).

Secondary Outcome Measures

PROMS
Patient reported outcomes reported on a visual analog scale from 0 (no pain) to 10 (maximum pain).
Change in alveolar bone level
Radiographically measured alveolar bone level from the alveolar crest to the implant's neck, mesially and distally (measured in millimetres).
Change in gingival recession
Gingival recession measured at six points per implant with a periodontal probe, from the cementum-enamel junction to the bottom of the probable pocket (measured in millimetres).
Bleeding on probing
Bleeding on probing (in percentage) assessed 30 seconds after probing, through a dichotomous scoring system used at six sites per implant using one (1) and zero (0) for presence or absence, respectively.
Implant survival rate
Percentage of implants that survived after 1 year follow-up (implants that remain in the patient's mouth after 1 year).

Full Information

First Posted
February 23, 2023
Last Updated
July 17, 2023
Sponsor
Universidade do Porto
Collaborators
EMS
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1. Study Identification

Unique Protocol Identification Number
NCT05811390
Brief Title
Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing
Official Title
Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing and Systemic Metronidazole With a 12 Months Follow-up, a Parallel Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Porto
Collaborators
EMS

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
The purpose of this study is to evaluate the clinical efficacy of ultrasonic instrumentation versus the use of an erythritol jet in the treatment of peri-implantitis.
Detailed Description
To carry out this study, the investigators considered a treatment protocol for periimplantitis consisting of 2 phases. The first phase corresponds to the non-surgical treatment of periimplantitis, which can be performed using various techniques. In the present study, it will be carried out using manual instrumentation (with ultrasound and curettes) or with an erythritol jet. In both cases, systemic antibiotic therapy with metronidazole will be performed. The results obtained during the follow-ups will allow the evaluation of the effectiveness of the treatment carried out. If this does not prove to be successful, through an evaluation of clinical and radiographic criteria, patients will be advised to undergo a second phase of treatment, in this case a surgical treatment of peri-implantitis, but which will no longer be part of the interventions carried out and documented in this study. Patients for whom the unsatisfactory treatment was considered effective will be allocated to a periimplant support treatment program, which means that they will be advised to carry out maintenance consultations at the FMDUP clinic with a specific and individualized periodicity in order to maintain the health of the periimplant tissues and the remaining oral cavity. The study will be carried out by the students of the Specialization in Periodontology and Oral Implantology 2021-2024 of the Faculty of Dental Medicine of the University of Porto (FMDUP).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periimplantitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
erythritol jet (EMS)
Arm Type
Experimental
Arm Description
An erythritol jet (Perioflow from EMS) will be used to debride the periodontal pockets of oral implants diagnosed with per-implantitis.
Arm Title
Manual instrumentation
Arm Type
Active Comparator
Arm Description
An ultrasonic handpiece will be used to debride the periodontal pockets of oral implants diagnosed with per-implantitis.
Intervention Type
Device
Intervention Name(s)
erythritol jet
Intervention Description
Use of an erythritol jet in the non-surgical treatment of periimplantitis together with systemic metronidazole
Intervention Type
Device
Intervention Name(s)
Manual instrumentation
Intervention Description
Use of manual instrumentation in the non-surgical treatment of periimplantitis together with systemic metronidazole
Primary Outcome Measure Information:
Title
Change in probing pocket depth
Description
The distance measured from the base of the sulcus or pocket to the free gingival margin at six points per implant (measured in millimetres).
Time Frame
0, 3, 6, 12 months
Secondary Outcome Measure Information:
Title
PROMS
Description
Patient reported outcomes reported on a visual analog scale from 0 (no pain) to 10 (maximum pain).
Time Frame
0 months
Title
Change in alveolar bone level
Description
Radiographically measured alveolar bone level from the alveolar crest to the implant's neck, mesially and distally (measured in millimetres).
Time Frame
0,12 months
Title
Change in gingival recession
Description
Gingival recession measured at six points per implant with a periodontal probe, from the cementum-enamel junction to the bottom of the probable pocket (measured in millimetres).
Time Frame
0, 3, 6, 12 months
Title
Bleeding on probing
Description
Bleeding on probing (in percentage) assessed 30 seconds after probing, through a dichotomous scoring system used at six sites per implant using one (1) and zero (0) for presence or absence, respectively.
Time Frame
0, 3, 6, 12 months
Title
Implant survival rate
Description
Percentage of implants that survived after 1 year follow-up (implants that remain in the patient's mouth after 1 year).
Time Frame
0, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At least 1 osseointegrated implant diagnosed with peri-implantitis (according to the new Classification of Periodontal and Peri-implant Diseases and Conditions) and rehabilitated with screw-retained crown Patients of legal age (≥18 years old) Exclusion Criteria: Uncontrolled systemic pathologies, namely diabetes mellitus (HbA1c > 7% or >53 mmol/mol) Pregnant or lactating patients Severe smoking (>20 cigarettes/day) Systemic pathologies, medication or treatments that cause alterations in bone metabolism (for example: osteoporosis, bisphosphonates, radiotherapy of the head and neck) Patients who missed study control visits Patients who have received systemic antibiotic therapy in the last 2 months Patients with allergies to any of the components used in the study, namely to erythritol Implants that have previously undergone surgical treatment for peri-implantitis Implants with bone loss greater than 2/3 of their length and/or mobility
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Nogal Dias
Phone
+ 351 220 408 640
Ext
8640
Email
abdias@reit.up.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Isabel Moreira
Organizational Affiliation
Faculdade de Medicina Dentária da Universidade do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry at the University of OPorto
City
OPorto
ZIP/Postal Code
4200-393
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Nogal Dias
Phone
+351 220 408 640
Ext
8640
Email
abdias@reit.up.pt

12. IPD Sharing Statement

Plan to Share IPD
No

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Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing

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