The aim of the present prospective cohort study is to assess the clinical and microbiological effects and patient-reported pain in the non-surgical treatment of peri-implantitis using a pocket irrigator/evacuator device
ID
Bron
Verkorte titel
Aandoening
Peri-implantitis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Mean peri-implant bleeding score (%)
Achtergrond van het onderzoek
The most effective approach to treat peri-implantitis remains to be found. Recently, a new pocket irrigator/evacuator device, The Fluxion®, based on an alternated interplay between vacuum and fluid (water), has been introduced. A periodontal study showed decreased probing pocket depths and reduced bleeding on probing1. Moreover patients reported less pain after treatment compared to conventional treatment. Whether the pocket irrigator can be used for treatment of peri-implantitis seems unknown.
Doel van het onderzoek
The aim of the present prospective cohort study is to assess the clinical and microbiological effects and patient-reported pain in the non-surgical treatment of peri-implantitis using a pocket irrigator/evacuator device
Onderzoeksopzet
Start inclusion; march 2018
Data collection; march 2018 - march 2019
Data analysis; april 2019
Writing manuscript; june 2019
Submission; july 2019
Onderzoeksproduct en/of interventie
All patients receive extensive oral hygiene instructions (using an electric toothbrush, interdental brushes and floss (Oral-B® superfloss or Meridol® floss, at implants in the esthetic zone only) and mechanical non-surgical debridement of the remaining dentition and the supramucosal areas of the implants using ultrasonic instrumentation (EMS®) and hand instruments (scalers and curettes) in one session. The submucosal areas of the infected implants will be irrigated using the Pocketirrigator for 25 seconds per site (4 sites per implant), twice weekly during a period of 3 weeks.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-The patient is ≥ 18 years of age;
-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 progressive loss of marginal bone ≥ 2mm , as compared to the baseline radiograph (after placing the definitive restoration) in combination with bleeding and/or suppuration on probing (Lang and Berglundh 2011);
-The implants have been in function for at least two years;
-The patient is capable of understanding and giving informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Medical and general contraindications for the procedures;
- A history of local radiotherapy to the head and neck region;
- Uncontrolled diabetes (HbA1c < 7% or < 53 mmol/mol);
- Smoking
- Use of antibiotics during the last 3 months;
- Long-term use of anti-inflammatory drugs;
- Active periodontitis of the remaining dentition (PPD > 5 mm);
- Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
- 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 treatment of the peri-implantitis lesions during the last 3 months (scaling or curettage)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7746 |
| Ander register | METC UMCG : METC2017.644 |