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Clinical and microbiological evaluation of different implant surface decontaminating procedures in the surgical treatment of peri-implantitis; a double blind placebo controlled randomized clinical study

Clinical and microbiological evaluation of different implant surface decontaminating procedures in the surgical treatment of peri-implantitis; a double blind placebo controlled randomized clinical study - Implant surface decontamination in peri-implantitis treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON34646
Enrollment
60
Registered
2010-03-26
Start date
2010-04-21
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

infection of the gingiva surrounding a dental implant peri-implantitis

Interventions

Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline and either 1 minute of local appli

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) The patient is >= 18 years of age; 2) 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 a loss of marginal bone >= 2 mm as compared to a fixed reference point on the dental implant, in combination with bleeding and/or suppuration on probing and a peri-implant probing depth >= 5 mm; 3) The implants have been exposed to the oral environment for at least two years; 4) The patient is capable of understanding and giving informed consent.

Exclusion criteria

Exclusion criteria: 1) Medical and general contraindications for the surgical procedures; 2) A history of local radiotherapy to the head and neck region; 3) Pregnancy and lactation; 4) Diabetes; 5) Systemic use of antibiotics during the last 2 months; 6) Long-term use of anti-inflammatory drugs; 7) Incapability of performing basal oral hygiene measures as a result of physical or mental disorders; 8) Active, uncontrolled periodontal pathology of the remaining dentition; 9) Local use of antibiotics or use of other anti-septic / antimicrobial therapies in the oral cavity during the last 2 months; 10) Bruxism; 11) Implants placed in skin grafted areas; 12) Implants with bone loss due to other reasons than bacterial infection (e.g. loose screw, inadequate positioning of the implant); 13) Implants with bone loss exceding 2/3 of the length of the implant or implants with bone loss beyond the transverse openings in hollow implants; 14) Implant mobility; 15) Implants at which no postition can be identified where proper probing measurements can be performed; 16) Previous surgical treatment of the peri-implantitis lesions; 17) Previous non-surgical treatment of the peri-implantitis lesions during the last 6 months (scaling or curretage).

Design outcomes

Primary

MeasureTime frame
The primary study parameter is the modified bleeding index.

Secondary

MeasureTime frame
Secundary study parameters are: - Microbial composition of the biofilm covering the dental implant surface; - Microbiological composition of the peri-implant sulcus; - Probing pocket depth; - Suppuration on probing; - Radiographic marginal bone level on standardized intraoral radiographs; - Modified plaque index; - Implant calculus index; - Marginal soft tissue recession (REC); - 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; - Complications and adverse events; - Patient satisfaction.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)