Outcome Indicators of Non-surgical Therapy of Peri-implantitis

Not Applicable

Completed

• Conditions: Infections; Peri-Implantitis
• Interventions: Procedure: Non surgical debridement of peri-implantitis

• Registration Number: NCT05539755
• Lead Sponsor: Universitat Internacional de Catalunya

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-07-12
• Status Verified: 2022-09
• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-12
• Last Update Submitted: 2022-09-12
• Study First Posted: 2022-09-14
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Non-surgical therapy of peri-implantitis	Non surgical debridement of peri-implantitis	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).

Primary Outcome Measures

Name	Time	Method
Disease resolution	6 months	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

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

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Barcelona, Catalonia, Spain