There are no differences in clinical treatment outcome between mechanical debridement alone or mechanical debridement along with use of Delmopinol for a time period of 3 months in treating peri-implant mucositis.
ID
Bron
Aandoening
Peri - implant mucositis / Peri-implantaire mucositis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Change in bleeding on Probing
Achtergrond van het onderzoek
Peri- implant mucositis describes an inflammatory lesion that resides in the mucosa around osseointegrated dental implants. If left untreated, periimplant mucositis can lead to periimplantitis with accompanying bone loss.Current recommendation for treatment is mechanical debridement with or without antiseptics in addition to reinforcement of self performed oral hygiene. Antibiofilm agent Delmopinol has been suggested as an alternative to Chlorhexidine. However, there are still no studies to assess the effect of Delmopinol on treatment of peri-implant mucositis.
Doel van het onderzoek
There are no differences in clinical treatment outcome between mechanical debridement alone or mechanical debridement along with use of Delmopinol for a time period of 3 months in treating peri-implant mucositis.
Onderzoeksopzet
-Screening
- Visit 1 treatment
- Visit 2 - 1 month after treatment
- Visit 3 - 3 month follow up
Onderzoeksproduct en/of interventie
- Mechanical debridement alone (along with placebo)
- Mechanical debridement along with Delmopinol mouthrinse
- Mechanical debridement along with Chlorhexidine mouthrinse
Publiek
J. Philip
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
The Netherlands
j.philip@acta.nl
Wetenschappelijk
J. Philip
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
The Netherlands
j.philip@acta.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Human adult patients with at least one screw type dental implant
- Bleeding on probing and / pus (< 0.25 N probing pressure)around at least one dental implant
- Implant in function at least 1 year, no radiographic boneloss beyond 2 mm compared to baseline radiograph
- Informed consent obtained after verbal and written information by investigator.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Osseointegrated dental implant with more than 2 mm boneloss as identified by comparing current radiograph with radiograph completed at time of prosthetic restoration.
- Patients smoking more than 20 sig/day
-Uncontrolled Diabetes Mellitus
- Untreated periodontitis
- Antibiotic/antiinflammatory use within last one month before start of study.
-Pregnancy and lactation
- psychiatric disorders
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5159 |
| NTR-old | NTR5299 |
| Ander register | EudraCT number // METC : 2014-004825-42 // NL.51404.029.15 |