The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plus metronidazole therapy in conjunction with initial non-surgical treatment of peri-implantitis. The secondary objective is to…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the mean peri-implant bleeding score.
Secondary outcome
- Full-mouth periodontal bleeding score;
- Mean peri-implant and full-mouth periodontal suppuration on probing score (%);
- Mean peri-implant and full-mouth periodontal probing pocket depth;
- Mean peri-implant and full-mouth periodontal plaque score (%);
- Marginal soft tissue recession (REC);
- Radiographic marginal peri-implant bone level on standardized intraoral
radiographs;
- Microbiological composition of the peri-implant and periodontal area;
- Need for additional surgery at teeth and implants
- Implant failure, defined as implant mobility of previously clinically
osseointegrated implants and removal of non-mobile implants because of
progressive marginal bone loss or infection;
- Tooth loss, defined as removal of teeth because of progressive marginal bone
loss or infection;
- Complications and adverse events.
Background summary
Peri-implantitis is an infectious disease that resides in the mucosa
surrounding dental implants and also affects the supporting bone. The number of
implants placed in everyday clinical practice is continuously increasing, and
it is anticipated that the prevalence of peri-implantitis will further
increase. This underlines the necessity for a predictable therapy. Scientific
literature provides very little evidence for an effective intervention protocol
for treatment of peri-implantitis.
Study objective
The primary objective of this controlled clinical trial is to evaluate the
clinical effect of systemic amoxicillin plus metronidazole therapy in
conjunction with initial non-surgical treatment of peri-implantitis. The
secondary objective is to assess the microbiological effectiveness of this
peri-implantitis treatment approach.
Study design
The present study is a single-blind, randomized controlled clinical trial.
Intervention
Patients with implants affected by peri-implantitis will receive initial
periodontal treatment existing of oral hygiene instructions and mechanical
cleansing of both implants and remaining dentition. Immediately after initial
periodontal therapy patients will be instructed to rinse their mouth with 0.12%
chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily
during 30 seconds for 2 weeks. Additionally patients will receive a recipe for
medication consisting of 500 mg amoxicillin and 500 mg metronidazol to be taken
every 8 hours for the following 7 days or no recipe.
Study burden and risks
Patients will have one additional appointment for research purposes only
(informed consent, dental impression, digital intra oral pictures). All other
data will be collected during intake and the regular follow-up visit (clinical
parameters, microbiological samples, questionnaires, x-rays). Since the regular
protocol for treatment of peri-implantitis is evaluated no additional risks are
involved with participation in this study.
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
1) The patient is >= 18 years of age;
2) The patient has at least one endosseous implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Peri-implantitis is defined as a loss of marginal bone >= 2 mm as compared to the shoulder of the implant (the level at which the bone is normally located immediately after implant placement), in combination with bleeding and/or suppuration on probing and a peri-implant probing depth >= 5 mm; ;3) The implants have been in function for at least two years;;4) The patient is capable of understanding and giving informed consent.
Exclusion criteria
1) Medical and general contraindications for the surgical procedures;
2) A history of local radiotherapy to the head and neck region;
3) Pregnancy and lactation;
4) Uncontrolled diabetes (HbA1c < 7% or < 53 mmol/mol)
5) Mononucleosis infectiosa
6) Organic neurological disorders
7) Use of antibiotics during the last 3 months;
8) Known allergy to amoxicillin, metronidazole or chlorhexidine;
9) Long-term use of anti-inflammatory drugs;
10) Full edentulism (no remaining teeth, only implants)
11) Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
12) Implants placed in areas augmented with autogenous bone from the crista iliac region;
13) Implants placed in skin grafted areas;
14) Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond the transverse openings in hollow implants;
15) Implant mobility;
16) Implants at which no position can be identified where proper probing measurements can be performed;
17) Previous surgical treatment of the peri-implantitis lesions;
18) Previous non-surgical treatment of the peri-implantitis lesions during the last 6 months (scaling or curretage).
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2012-003233-42-NL |
| CCMO | NL41441.042.12 |