Treatment considerations for the surgical therapy of peri-implantitis

Phase 4

Recruiting

• Conditions: peri-implant disease; peri-implant infection; 10004018; 10041297

• Registration Number: NL-OMON49393
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 0

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;
- 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 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;
- significant contra-indications to the use of antibiotics due to other
medicines;
- 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 bleeding on probing (< 20%), probing
pocket depth < 6mm, plaque < 20%;
- active periodontal disease at the remaining dentition (probing pocket depth >=
6mm, bleeding on probing >= 20%) or insufficient oral hygiene (plaque >= 20%);
- use of antibiotics during the last 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is mean peri-implant bleeding on probing (in %)</p><br>