Non-surgical treatment of peri-implantitis.

Non-surgical treatment of peri-implantitis: A randomized controlled trial, single blind study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26244

Enrollment

Registered

2012-12-17

Start date

2012-12-18

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

1. Non-surgical treatment of peri-implantitis with the adjunctive use of systemic antibiotics

2. Non-surgical treatment of peri-implantitis without the adjunctive use of systemic antibiotics.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Dentate or edentate patients with at least one screw-type titanium implant; 2. The implant should be in function for at least a period of 12 months; 3. Peri-implant intraosseous defect with at least 3 mm depth measured from the neck; 4. The extent of bone loss will be measured on the basis of peri-apical radiographs; 5. Probing depth at the deepest site at least 5mm combined with bleeding and/or suppuration; 6. Patient above 18 years of age; 7. Psychological appropriateness; 8. Signed Informed Consent.

Exclusion criteria

Exclusion criteria: 1. Patient with a history of taking systemic antibiotics in the preceding 3 months; 2. Patient allergic to penicillin (amoxicillin) or metronidazole; 3. Systemic diseases like diabetes, HIV, Sjögren, SLE; 4. Use of NSAID’s in the last 4 weeks; 5. Current pregnancy or lactating; 6. Mobile implants.

Design outcomes

Primary

Measure	Time frame
In periodontal literature a general consensus is used for clinical attachment level (CAL). A difference of 1 mm between treatments for CAL changes at initially deep pockets would be clinically relevant.	—

Secondary

Measure	Time frame
In periodontal literature a general consensus is used for pocket probing depth (PPD). A difference of 1 mm between treatments for PPD changes at initially deep pockets would be clinically relevant. Bone loss should be stabilized and not show any further loss on the radiographs. Plaqueaccumulation and bleeding on probing reduction by a minimum of 50%. The end point for microbiological parameters are less anaerobic bacteria and a shift in composition.	—

Measure

Time frame

In periodontal literature a general consensus is used for pocket probing depth (PPD). A difference of 1 mm between treatments for PPD changes at initially deep pockets would be clinically relevant. Bone loss should be stabilized and not show any further loss on the radiographs. Plaqueaccumulation and bleeding on probing reduction by a minimum of 50%. The end point for microbiological parameters are less anaerobic bacteria and a shift in composition.

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Contacts

Public ContactMarja Laine

Section Periodontology, ACTA Gustav Mahlerlaan 3004

+31 (0)20 5980498

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)