The primary objective of this randomized controlled trial is to compare the clinical effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using air polishing or hand instruments. The secondary objective…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 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 and bone defect configuration
on standardized intraoral radiographs;
- Microbiological composition of the peri-implant and periodontal area;
- 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 condition of the tissues around
osseointegrated implants resulting in loss of supporting bone and clinical
signs of inflammation (bleeding and/or suppuration on probing). Various
treatment modalities have been described in the literature including mechanical
debridement, pharmaceutical therapy (chlorhexidine, local or systemic
antibiotics) and surgical procedures aimed at removing bacteria, smoothening of
the implant surface and decontamination of the implant surface. Despite these
various treatment strategies, the most effective treatment option in treating
peri-implantitis lesions remains unclear. Therefore the search for a
potentially beneficial treatment modality for implant biofilm removal is still
imperative. One such potentially beneficial treatment might be the use of air
polishing. Modern air polishing devices and their specific powders for
subgingival application are becoming increasingly significant in the context of
maintenance therapy. It has been shown that supportive therapy consisting of
debridement and decontamination of implants and suprastructures with air
polishing leads to better clinical results than conventional mechanical
supportive therapy. On the basis of these considerations the aim of the present
study is to investigate the clinical, microbiological and radiographical
effectiveness of decontamination of the implant surface during resective
surgical treatment of peri-implantitis using air polishing.
Study objective
The primary objective of this randomized controlled trial is to compare the
clinical effect of decontamination of the implant surface during the surgical
treatment of peri-implantitis using air polishing or hand instruments. The
secondary objective is to assess the microbiological and radiographical effect
of these treatment options of peri-implantitis.
Study design
This protocol consists of a single-blind, randomized, controlled clinical
trial.
Intervention
All patients with peri-implantitis will be treated in a surgical way. Before
surgical exposure of the affected implants suprastructures will be removed if
reasonably possible. Granulation tissue will be removed and angular bone
defects will be corrected. Surgical exposure will be followed by mechanical
cleansing using gauzes and cotton pellets soaked in saline and airpolishing
(test) or either hand instrumentation (control). Hereafter implants are rinsed
with 1 minute of saline. Finally, the gingival flap will be returned slightly
apical (in order to reduce pockets) and will be firmly sutured. The surgery is
followed by 2 weeks of rinsing with 0.12% chlorhexidine + 0.05% cetylpyridinium
chloride without alcohol twice daily during 30 seconds. After 2 weeks the
sutures will be removed. Follow-up will take place at 3, 6, 9 and 12 months.
Study burden and risks
In addition to the regular follow-up visits (after 2 weeks and 3, 6, 9 and 12
months) patients will have one additional appointment for research purposes
only. All other data will be collected during the regular follow-up visits
(clinical data, microbiological samples, digital intra oral pictures, x-rays).
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Antonius Deusinglaan 1
Groningen 9713 AV
NL
Listed location countries
Age
Inclusion criteria
- The patient is * 18 years of age;
- Unsuccessful treatment outcome in non-surgical treatment phase (see concomitant METC proposal). The patient has at least one endosseous implant in the oral cavity with remaining clinical and radiographical signs of peri-implantitis. Peri-implantitis is defined as probing pockets depths (PPD) of * 5mm in combination with bleeding and/or suppuration on probing and radiographic bone loss * 2 mm after placing the definitive restoration.
- The implants have been in function for at least two years;
- The patient is capable of understanding and giving informed consent.
Exclusion criteria
- Medical and general contra-indications for the procedures;
- A history of local radiotherapy to the head and neck region;
- Pregnancy and lactation;
- Uncontrolled diabetes (HbA1c < 7% or < 53 mmol/mol);
- Use of antibiotics during the last 3 months;
- Known allergy to chlorhexidine;
- Long-term use of anti-inflammatory drugs;
- Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
- Active periodontal disease at remaining dentition (Probing pocket depth*6mm, bleeding*20%) and/or insufficient oral hygiene (plaque*20%)
- 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;
- Implant mobility;
- Implants at which no position can be identified where proper probing measurements can be performed;
- Previous surgical treatment of the peri-implantitis lesions;
- Chronic bronchitis and asthma
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 |
|---|---|
| CCMO | NL58447.042.16 |