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Non surgical peri-implantitis treatment

Clinical, microbiological, radiographical and immunological evaluation of implant surface decontamination using air polishing in the non- surgical treatment of peri-implantitis; a randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23755
Enrollment
80
Registered
2020-01-29
Start date
2016-10-27
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Peri-implantitis

Interventions

Airpolishing (Perioflow® EMS), Ultrasonic device (Piezon® EMS)

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The patient is = 18 years of age; The patient has at least one endosseous implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Peri-implantitis is defined as progressive loss of marginal bone = 2mm, as compared to the baseline radiograph (after placing the definitive restoration) in combination with bleeding and/or suppuration on probing; The implants have been in function for at least two years; The patient is capable of understanding and giving informed consent.

Exclusion criteria

Exclusion criteria: - Medical and general contraindications for the procedures; - A history of local radiotherapy to the head and neck region; - Pregnancy and lactation; - Uncontrolled diabetes mellitus (HbA1c < 7% or < 53 mmol/mol); - Use of antibiotics during the last 3 months; - Known allergy to chlorhexidine; - Long-term use of anti-inflammatory drugs; - Incapability of performing basal oral hygiene measures as a result of physical or mental disorders; - Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond the transverse openings in hollow implants; - Implant mobility; - Implants at which no position can be identified where proper probing measurements can be performed; - Previous surgical treatment of the peri-implantitis lesions; - Previous non-surgical treatment of the peri-implantitis lesions during the last 3 months (scaling or curettage) - Chronic bronchitis and asthma - Presents of natural dentition (only for patients in heamatological study)

Design outcomes

Primary

MeasureTime frame
- Mean peri-implant bleeding score (%) - Mean peri-implant and full-mouth periodontal suppuration on probing score (%); - Mean peri-implant and full-mouth periodontal probing pocket depth; - Mean peri-implant and full-mouth periodontal plaque score (%); - mPISA

Secondary

MeasureTime frame
- Full-mouth periodontal bleeding score; - Marginal soft tissue recession (REC); - Radiographic marginal peri-implant bone level - Microbiological composition of the peri-implant and periodontal area; - Need for additional surgery at teeth and implants; - Implant failure, defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection; - Tooth loss, defined as removal of teeth because of progressive marginal bone loss or infection; - Complications and adverse events. - Immunological biomarkers (IL-1b, IL-6, TNFa, MMP8-, MCP-1, MIP1a, OPG, sRANKL, INFgamma, G-CSF)

Contacts

Public ContactDiederik Hentenaar

University of Groningen

d.f.m.hentenaar@umcg.nl(+31) 503613846

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)