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Non-surgical treatment of peri-implantitis.


- candidate number14107
- NTR NumberNTR3756
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-dec-2012
- Secondary IDs39371.018.12 METC AMC
- Public TitleNon-surgical treatment of peri-implantitis.
- Scientific TitleNon-surgical treatment of peri-implantitis: A randomized controlled trial, single blind study.
- ACRONYM
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedPeri-implantitis
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 18-dec-2012
- planned closingdate31-dec-2014
- Target number of participants48
- Interventions1. 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.
- Primary outcomeIn 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 outcomeIn 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.
- Timepoints1. Baseline;
2. Evaluation at three months;
3. Evaluaion at twelve months.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Marja Laine
- CONTACT for SCIENTIFIC QUERIESDr. Marja Laine
- Sponsor/Initiator Academic Center Dentistry Amsterdam (ACTA)
- Funding
(Source(s) of Monetary or Material Support)
Academic Center Dentistry Amsterdam (ACTA)
- PublicationsN/A
- Brief summaryRationale:
Peri-implantitis is an inflammation of the tissues around dental implants. Interventions to treat this disease include removal of the dental biofilm around the titanium implants. In this study two recognized treatment options of peri-implantitis are compared. Mechanical cleaning of the implant surface combined with systemic antibiotics is compared to mechanical cleaning alone.

Objective:
The objective is to evaluate the adjunctive effect of systemic antibiotics for the treatment of peri-implantitis in comparison to treatment without systemic antibiotics on the difference in clinical attachment level (CAL) three and twelve months after treatment.

Study design:
Randomized controlled trial, single blind.

Study population:
Adult patients (> 18 years) with peri-implantitis with at least one oral implant in function.

Intervention:
One group receives a non-surgical treatment of peri-implantitis (mechanical debridement of the surface of dental implants) in combination with systemic antibiotics (amoxicillin 375 mg and metronidazole 250 mg three times a day for 7 days). The other group receives the same non-surgical treatment of peri-implantitis without the adjunctive use of systemic antibiotics. This is a recognized treatment for periodontitis, an inflammation of the tissues around natural teeth.

Main study parameters/endpoints:
The main outcome is the difference in clinical attachment level (CAL) of the deepest site of the target implant (baseline versus three months after treatment).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The burden and risks in this study are not different when compared to standard clinical treatment. The antibiotics used in this study are regularly used in dental practices and may cause side effects. The appointments will be performed according to regular treatment appointments; the extra time in this study for each subject is about 40 minutes.
- Main changes (audit trail)
- RECORD17-dec-2012 - 6-jan-2013


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