Outcome Indicators of Non-surgical Therapy of Peri-implantitis

Outcome Indicators of Non-surgical Therapy of Peri-implantitis: a 6-months

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.

Study Overview

• Status: Completed
• Conditions: Infections; Peri-Implantitis
• Intervention / Treatment: Procedure: Non surgical debridement of peri-implantitis

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Barcelona, Catalonia, Spain, 08195
      • Universitat Internacional de Catalunya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Non-surgical therapy 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).

Procedure: Non surgical debridement of peri-implantitis; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): June 1, 2022
• Study Completion (ACTUAL): July 12, 2022

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (ACTUAL): September 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: PER-ECL-2020-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No