Outcome Indicators of Non-surgical Therapy of Peri-implantitis

Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05539755
• Other study ID #: PER-ECL-2020-06
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: July 12, 2022

Study information

• Verified date: September 2022
• Source: Universitat Internacional de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 12, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Peri-Implantitis

Intervention

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.

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Barcelona	Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Changes in Bleeding on probing (BoP)	Assessed dichotomously (yes/no) in six sites per tooth	From baseline to 6 months
Secondary	Changes in Suppuration on probing (BoP)	Assessed dichotomously (yes/no) in six sites per tooth	From baseline to 6 months
Secondary	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
Secondary	Changes	Measured in mm from the mucosal margin to mucogingival line in 6 sites per tooth	From baseline to 6 months
Secondary	Plaque index (PI)	Calculated by assigning a binary score to each surface (1 for plaque present, 0 for absent).	From baseline to 6 months