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Clinical and microbiological effect of submucosal irrigation with the Pocketirrigator for treatment of peri-implantitis

Clinical and microbiological effect of submucosal irrigation with the Pocketirrigator for treatment of peri-implantitis - Pocketirrigation and peri-implantitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53366
Enrollment
24
Registered
2018-04-26
Start date
2018-05-01
Completion date
Unknown
Last updated
2024-04-15

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

Peri-implant pockets will be irrigated using the Pocketirrigator 2 times per week during a period of 3 weeks. Patients will receive oral hygiene instructions and the remaining dentition and supramuc

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 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; - Uncontrolled diabetes (HbA1c 5 mm); - 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 treatment of the peri-implantitis lesions during the last 3 months (scaling or curettage).

Design outcomes

Primary

MeasureTime frame
The main study parameter is the mean peri-implant bleeding score (%).

Secondary

MeasureTime frame
- Full-mouth periodontal 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 (%); - Marginal soft tissue recession (REC); - 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. - Patient satisfaction

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)