NL-OMON49393RecruitingPhase 4
Treatment considerations for the surgical therapy of peri-implantitis - Surgical considerations in treating peri-implantitis
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •- 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.
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