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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43349

Enrollment

Unknown

Registered

2016-10-28

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-implant disease peri-implant infection

Interventions

Dental implants

Non-surgical

Peri-implantitis

All patients with peri-implantitis will be treated in a non-surgical way. Patients will receive a full mouth periodontal and peri-implant treatment by a professional oral hygienist in one or multipl

Airpolishing

Eligibility

Age

18 Years to 64 Years

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 (Lang and Berglundh 2011); - 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

Design outcomes

Primary

Measure	Time 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 (%);	—

Secondary

Measure	Time 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. - Haematological parameters (only for 20 edentulous patiënts already participating in the non-surgical RCT): - number of leucocytes, - number of erythrocytes, - erythrocyte sedimentation rate (ESR), - number of thrombocytes, - level of interleukin 6, - concentration of C-reactive protein (CRP).	—

Measure

Time 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. - Haematological parameters (only for 20 edentulous patiënts already participating in the non-surgical RCT): - number of leucocytes, - number of erythrocytes, - erythrocyte sedimentation rate (ESR), - number of thrombocytes, - level of interleukin 6, - concentration of C-reactive protein (CRP).

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)