search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Effect of Delmopinol on treatment of inflammation around dental implants


- candidate number22451
- NTR NumberNTR5299
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jul-2015
- Secondary IDs2014-004825-42 EudraCT number
- Public TitleEffect of Delmopinol on treatment of inflammation around dental implants
- Scientific TitleEffect of Delmopinol on treatment of Peri - implant mucositis: a randomised controlled clinical trial
- ACRONYM
- hypothesisThere 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.
- Healt Condition(s) or Problem(s) studiedPeri - implant mucositis
- Inclusion criteria- 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.
- Exclusion criteria- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate1-mrt-2016
- Target number of participants85
- Interventions- Mechanical debridement alone (along with placebo)
- Mechanical debridement along with Delmopinol mouthrinse
- Mechanical debridement along with Chlorhexidine mouthrinse
- Primary outcome- Change in bleeding on Probing
- Secondary outcome- Plaque index
- Pocket probing depth
-Microbiological changes
- Timepoints-Screening
- Visit 1 treatment
- Visit 2 - 1 month after treatment
- Visit 3 - 3 month follow up
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES J. Philip
- CONTACT for SCIENTIFIC QUERIES J. Philip
- Sponsor/Initiator ACTA Dental Research BV
- Funding
(Source(s) of Monetary or Material Support)
ACTA
- Publications
- Brief summaryPeri- 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.
- Main changes (audit trail)
- RECORD14-jul-2015 - 27-nov-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl