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Outcome Indicators of Non-surgical Therapy of Peri-implantitis

Primary Purpose

Peri-Implantitis, Infections

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Non surgical debridement of peri-implantitis
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects over 18 years old
  • At least one implant in function for more than 1 year diagnosed with peri-implantitis following the case definition of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018).

Exclusion Criteria:

  • Previous surgical therapy of peri-implantitis
  • Allergy to metronidazole
  • Clinical implant mobility
  • Pregnancy or lactating females
  • Previous non-surgical treatment (i.e., submucosal debridement) of the affected implants at least 12 months before
  • Use of systemic antibiotics during the previous 3 months as well as use of systemic antibiotics for endocarditis prophylaxis,
  • Systemic diseases, medications, or conditions that may compromise wound healing and influence the outcome of the therapy.

Sites / Locations

  • Universitat Internacional de Catalunya

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-surgical therapy of peri-implantitis

Arm Description

Subjects over 18 years old were consecutively included in the study if they present at least one implant in function for more than 1 year diagnosed with peri-implantitis following the case definition of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018).

Outcomes

Primary Outcome Measures

Disease resolution
Probing pocket depth reduction to 5 mm without bleeding on probing (BoP) or <5 mm irrespective to BoP in all implant sites together with lack of progression of peri-implant bone loss

Secondary Outcome Measures

Changes in PPD
Measured in mm from the mucosal margin to the base of the peri-implant pocket in 6 sites per tooth
Changes in Bleeding on probing (BoP)
Assessed dichotomously (yes/no) in six sites per tooth
Changes in Suppuration on probing (BoP)
Assessed dichotomously (yes/no) in six sites per tooth
Changes in soft tissue margin
Measured in mm from the mucosal margin to the most apical portion of the crown in 6 sites per tooth
Changes
Measured in mm from the mucosal margin to mucogingival line in 6 sites per tooth
Plaque index (PI)
Calculated by assigning a binary score to each surface (1 for plaque present, 0 for absent).

Full Information

First Posted
September 6, 2022
Last Updated
September 12, 2022
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT05539755
Brief Title
Outcome Indicators of Non-surgical Therapy of Peri-implantitis
Official Title
Outcome Indicators of Non-surgical Therapy of Peri-implantitis: a 6-months
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

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
Objectives: To identify patient and implant indicators influencing the non-surgical therapeutic outcomes of peri-implantitis at 6-months follow-up. Material and methods: This prospective cohort study included patients with at least one implant diagnosed with peri-implantitis according to the 2017 World Workshop. Non-surgical therapy consisted in a mechanical debridement of the peri-implant pockets combined with the metronidazole 500 mg every 8 hours during 7 days. At baseline and at 6 months, clinical and radiographic variables were collected to calculate the success of the therapy. The influence of patient and implant/prosthetic variables on disease resolution were assessed trough simple and multiple logistic regression analysis at patient and implant level using generalized estimation equations models.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis, Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-surgical therapy of peri-implantitis
Arm Type
Experimental
Arm Description
Subjects over 18 years old were consecutively included in the study if they present at least one implant in function for more than 1 year diagnosed with peri-implantitis following the case definition of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018).
Intervention Type
Procedure
Intervention Name(s)
Non surgical debridement of peri-implantitis
Intervention Description
The procedure was standardized as follows: the implants' prosthesis was checked for its cleansability, and retrieved when possible. Then, the prosthesis was modified following a previously described elsewhere (de Tapia et al., 2019). After local anaesthesia (articaine 4% and adrenaline 1:100,000), the implant surfaces were cleaned with ultrasonic devices (Newtron P5, Satelec Acteon; Olliergues, France) with the steel alloy H3 dental ultrasonic scaler tip (H3, Satelec Acteon; Olliergues, France), curettage (SyG 7/89 Everdge, Hu-Friedy; Chicago, IL, USA) of the bone defect was performed, and glycine air powder applied submucosally (Air-flow® powder subgingival PERIO, EMS; Nyon, France) with an air-flow piezon device (Air-flow master piezon®, EMS, Nyon; France). Oral hygiene instructions were given and metronidazole 500 mg every 8 h for 7 days was prescribed. Patients were scheduled at 3 months for supragingival plaque control and supragingival debridement, if needed.
Primary Outcome Measure Information:
Title
Disease resolution
Description
Probing pocket depth reduction to 5 mm without bleeding on probing (BoP) or <5 mm irrespective to BoP in all implant sites together with lack of progression of peri-implant bone loss
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in PPD
Description
Measured in mm from the mucosal margin to the base of the peri-implant pocket in 6 sites per tooth
Time Frame
From baseline to 6 months
Title
Changes in Bleeding on probing (BoP)
Description
Assessed dichotomously (yes/no) in six sites per tooth
Time Frame
From baseline to 6 months
Title
Changes in Suppuration on probing (BoP)
Description
Assessed dichotomously (yes/no) in six sites per tooth
Time Frame
From baseline to 6 months
Title
Changes in soft tissue margin
Description
Measured in mm from the mucosal margin to the most apical portion of the crown in 6 sites per tooth
Time Frame
From baseline to 6 months
Title
Changes
Description
Measured in mm from the mucosal margin to mucogingival line in 6 sites per tooth
Time Frame
From baseline to 6 months
Title
Plaque index (PI)
Description
Calculated by assigning a binary score to each surface (1 for plaque present, 0 for absent).
Time Frame
From baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects over 18 years old At least one implant in function for more than 1 year diagnosed with peri-implantitis following the case definition of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (Berglundh et al., 2018). Exclusion Criteria: Previous surgical therapy of peri-implantitis Allergy to metronidazole Clinical implant mobility Pregnancy or lactating females Previous non-surgical treatment (i.e., submucosal debridement) of the affected implants at least 12 months before Use of systemic antibiotics during the previous 3 months as well as use of systemic antibiotics for endocarditis prophylaxis, Systemic diseases, medications, or conditions that may compromise wound healing and influence the outcome of the therapy.
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08195
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Outcome Indicators of Non-surgical Therapy of Peri-implantitis

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