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Completed

NCT Number: NCT05811390

Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing

The purpose of this study is to evaluate the clinical efficacy of ultrasonic instrumentation versus the use of an erythritol jet in the treatment of peri-implantitis.

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Key information

Conditions

Periimplantitis Mouth Diseases Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry at the University of OPorto

Porto, Porto District, 4200-393, Portugal

About this study

To carry out this study, the investigators considered a treatment protocol for periimplantitis consisting of 2 phases. The first phase corresponds to the non-surgical treatment of periimplantitis, which can be performed using various techniques. In the present study, it will be carried out using manual instrumentation (with ultrasound and curettes) or with an erythritol jet. In both cases, systemic antibiotic therapy with metronidazole will be performed. The results obtained during the follow-ups will allow the evaluation of the effectiveness of the treatment carried out. If this does not prove to be successful, through an evaluation of clinical and radiographic criteria, patients will be advised to undergo a second phase of treatment, in this case a surgical treatment of peri-implantitis, but which will no longer be part of the interventions carried out and documented in this study. Patients for whom the unsatisfactory treatment was considered effective will be allocated to a periimplant support treatment program, which means that they will be advised to carry out maintenance consultations at the FMDUP clinic with a specific and individualized periodicity in order to maintain the health of the periimplant tissues and the remaining oral cavity. The study will be carried out by the students of the Specialization in Periodontology and Oral Implantology 2021-2024 of the Faculty of Dental Medicine of the University of Porto (FMDUP).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At least 1 osseointegrated implant diagnosed with peri-implantitis (according to the new Classification of Periodontal and Peri-implant Diseases and Conditions) and rehabilitated with screw-retained crown
  • Patients of legal age (≥18 years old)

Exclusion criteria

  • Uncontrolled systemic pathologies, namely diabetes mellitus (HbA1c > 7% or >53 mmol/mol)
  • Pregnant or lactating patients
  • Severe smoking (>20 cigarettes/day)
  • Systemic pathologies, medication or treatments that cause alterations in bone metabolism (for example: osteoporosis, bisphosphonates, radiotherapy of the head and neck)
  • Patients who missed study control visits
  • Patients who have received systemic antibiotic therapy in the last 2 months
  • Patients with allergies to any of the components used in the study, namely to erythritol
  • Implants that have previously undergone surgical treatment for peri-implantitis
  • Implants with bone loss greater than 2/3 of their length and/or mobility

Treatment and study plan

erythritol jet

Device

Use of an erythritol jet in the non-surgical treatment of periimplantitis together with systemic metronidazole

Manual instrumentation

Device

Use of manual instrumentation in the non-surgical treatment of periimplantitis together with systemic metronidazole

Primary outcomes

  1. Change in probing pocket depth

    Time frame: 0, 3, 6, 12 months

    The distance measured from the base of the sulcus or pocket to the free gingival margin at six points per implant (measured in millimetres).

Secondary outcomes

  1. PROMS

    Time frame: 0 months

    Patient reported outcomes reported on a visual analog scale from 0 (no pain) to 10 (maximum pain).

  2. Change in alveolar bone level

    Time frame: 0,12 months

    Radiographically measured alveolar bone level from the alveolar crest to the implant's neck, mesially and distally (measured in millimetres).

  3. Change in gingival recession

    Time frame: 0, 3, 6, 12 months

    Gingival recession measured at six points per implant with a periodontal probe, from the cementum-enamel junction to the bottom of the probable pocket (measured in millimetres).

  4. Bleeding on probing

    Time frame: 0, 3, 6, 12 months

    Bleeding on probing (in percentage) assessed 30 seconds after probing, through a dichotomous scoring system used at six sites per implant using one (1) and zero (0) for presence or absence, respectively.

  5. Implant survival rate

    Time frame: 0, 12 months

    Percentage of implants that survived after 1 year follow-up (implants that remain in the patient's mouth after 1 year).

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

  • EMS

Registry information

Official study title

Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing and Systemic Metronidazole With a 12 Months Follow-up, a Parallel Randomized Controlled Clinical Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2023
Registry last updated
Apr 6, 2025

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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