No registrations found.
ID
Source
Health condition
Peri-implantitis
Sponsors and support
Section Periodontology, ACTA
Gustav Mahlerlaan 3004
1081 LA Amsterdam
020-598 0 498
Intervention
Outcome measures
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.
Background 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.
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.
Study objective
N/A
Study design
1. Baseline;
2. Evaluation at three months;
3. Evaluaion at twelve months.
Intervention
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.
Gustav Mahlerlaan 3004
Marja Laine
Amsterdam 1081 LA
The Netherlands
+31 (0)20 5980498
Gustav Mahlerlaan 3004
Marja Laine
Amsterdam 1081 LA
The Netherlands
+31 (0)20 5980498
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3590 |
| NTR-old | NTR3756 |
| Other | METC AMC : 39371.018.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |