|- candidate number||14107|
|- NTR Number||NTR3756|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-dec-2012|
|- Secondary IDs||39371.018.12 METC AMC|
|- Public Title||Non-surgical treatment of peri-implantitis.|
|- Scientific Title||Non-surgical treatment of peri-implantitis: A randomized controlled trial, single blind study.|
|- Healt Condition(s) or Problem(s) studied||Peri-implantitis|
|- 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
6. Patient above 18 years of age;
7. Psychological appropriateness;
8. Signed Informed Consent.
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||18-dec-2012|
|- planned closingdate||31-dec-2014|
|- Target number of participants||48|
|- 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.
|- Primary outcome||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 outcome||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.
|- Timepoints||1. Baseline;|
2. Evaluation at three months;
3. Evaluaion at twelve months.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. Marja Laine|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Marja Laine|
|- Sponsor/Initiator ||Academic Center Dentistry Amsterdam (ACTA)|
(Source(s) of Monetary or Material Support)
|Academic Center Dentistry Amsterdam (ACTA)|
|- Brief summary||Rationale: |
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.
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.
Randomized controlled trial, single blind.
Adult patients (> 18 years) with peri-implantitis with at least one oral implant in function.
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
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
|- Main changes (audit trail)|
|- RECORD||17-dec-2012 - 6-jan-2013|