Outcome Indicators of Non-surgical Therapy of Peri-implantitis

NCT05539755 | Completed

• 1 other identifier: PER-ECL-2020-06
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-Implantitis; Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in PPD

  From baseline to 6 months

• Changes in Bleeding on probing (BoP)

  From baseline to 6 months

• Changes in Suppuration on probing (BoP)

  From baseline to 6 months

• Changes in soft tissue margin

  From baseline to 6 months

• Changes

  From baseline to 6 months

Study Arms (1)

Non-surgical therapy of peri-implantitis

EXPERIMENTAL

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

Interventions

Non surgical debridement of peri-implantitis PROCEDURE

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.

Non-surgical therapy of peri-implantitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Barcelona, Catalonia, 08195, Spain

Location

MeSH Terms

Conditions

Peri-Implantitis; Infections

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 14, 2022
• Study Start: January 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 12, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)