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NCT Number: NCT05539755

Outcome Indicators of Non-surgical Therapy of Peri-implantitis

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.

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Key information

Conditions

Peri-implantitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Internacional de Catalunya

Barcelona, Catalonia, 08195, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Disease resolution

    Time frame: 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 outcomes

  1. Changes in PPD

    Time frame: 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

  2. Changes in Bleeding on probing (BoP)

    Time frame: From baseline to 6 months

    Assessed dichotomously (yes/no) in six sites per tooth

  3. Changes in Suppuration on probing (BoP)

    Time frame: From baseline to 6 months

    Assessed dichotomously (yes/no) in six sites per tooth

  4. Changes in soft tissue margin

    Time frame: 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

  5. Changes

    Time frame: From baseline to 6 months

    Measured in mm from the mucosal margin to mucogingival line in 6 sites per tooth

  6. Plaque index (PI)

    Time frame: From baseline to 6 months

    Calculated by assigning a binary score to each surface (1 for plaque present, 0 for absent).

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2022
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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