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Surgical peri-implantitis treatment: regenerative approach and adjuvant antibiotic intervention

The use of bone substitutes and adjuvant antibiotic therapy in peri-implantitis surgery: a randomised controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27505
Enrollment
123
Registered
2019-11-15
Start date
2020-02-01
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

- 3- and 4-wall bone defects: the use of bone substitutes - 0-, 1- and 2-wall defects: the use of systemic amoxicillin and metronidazole

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - the patient is =18 years of age; - adult patients with at least one endosseous implant in the oral cavity with clinical and radiographical evidence of peri-implantitis. Peri-implantitis is defined as probing pocket depth (PPD) of = 6mm in combination with bleeding on probing (BOP) or suppuration on probing (SOP) and radiographic bone loss of =3mm after placing the definitive suprastructure (Berglundh et al. 2018); - the implants have been in function for at least 2 years; - the patient is capable of understanding and giving informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria prior to pre-treatment: - medical and general contra-indications for the procedure; - 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 intravenous bisphosphonates; - known allergy to chlorhexidine, amoxicillin and/or metronidazole; - long-term use of anti-inflammatory drugs - patient is incapable of performing basic oral hygiene measures as a result of physical or mental disorders; - implants with bone loss exceeding 2/3 of implant length or implants with bone loss beyond the transverse openings in hollow implants; - previous surgical treatment of the peri-implantitis lesions; - chronic bronchitis or asthma. Additional exclusion criteria after pre-treatment: - no peri-implantitis remaining: minor BoP (< 20%), PPD < 6mm, plaque < 20%; - active periodontal disease at the remaining dentition (PPD = 6mm, BOP = 20%) or insufficient oral hygiene (plaque = 20%); - use of antibiotics during the last 3 months.

Design outcomes

Primary

MeasureTime frame
-Mean peri-implant bleeding on probing (BoP)

Secondary

MeasureTime frame
- Full-mouth BoP; - Mean peri-implant and full mouth suppuration on probing score (SoP); - Mean peri-implant probing and full-mouth pocket depth (PPD) - Mean radiographical bone height in millimetres - Marginal soft tissue recession (REC) - Radiographic marginal peri-implant bone level and bone defect configuration on standardized intraoral radiographs and cone-beam computed tomographies - Microbiological composition of the peri-implant and periodontal area; - Implant failure, defined as implant mobility of previously 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; - failure of peri-implantitis treatment at 12 months after treatment: probing pocket depth (PPD) of = 6mm in combination with bleeding on probing (BOP) or suppuration on probing (SOP) and progressive radiographical peri-implant bone loss - Complication and adverse events

Contacts

Public ContactJarno Hakkers

University Medical Center Groningen

j.hakkers@umcg.nl0612905710

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)