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

Microbiological and clinical 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-OMON33406
Enrollment
30
Registered
2009-12-15
Start date
2009-08-01
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 followed by either 1 minute of rin

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 3 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 3 months; 10) Use of mouthrinses; 11) Bruxism; 12) Implants placed in skin grafted areas; 13) Implants with bone loss due to other reasons than bacterial infection (e.g. loose screw, inadequate positioning of the implant); 14) 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; 15) Implant mobility; 16) Implants at which no postition can be identified where proper probing measurements can be performed; 17) Previous surgical treatment of the peri-implantitis lesions; 18) Previous non-surgical treatment of the peri-implantitis lesions during the last 6 months (scaling or curretage).

Design outcomes

Primary

MeasureTime frame
The main study parameters is microbial composition of the biofilm covering the dental implant surface.

Secondary

MeasureTime frame
Secundary study parameters are: - Modified bleeding index - Probing pocket depth - Suppuration on probing - Microbiological composition of the peri-implant sulcus - 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)