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Outcome Indicators of Non-surgical Therapy of Peri-implantitis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05539755
Enrollment
75
Registered
2022-09-14
Start date
2021-01-01
Completion date
2022-07-12
Last updated
2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Peri-Implantitis

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.

Interventions

PROCEDURENon 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.

Sponsors

Universitat Internacional de Catalunya
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Disease resolution6 monthsProbing 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

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026