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van CCT (UK)

van CCT (UK)

How to treat peri-implantitis?

- candidate number22280
- NTR NumberNTR5185
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jun-2015
- Secondary IDsMETc2013.005 University Medical Center Groningen
- Public TitleHow to treat peri-implantitis?
- Scientific TitleClinical and microbiological evaluation of implant surface decontamination using 35% phosphoric etching gel during surgical treatment of peri-implantitis – a randomized clinical pilot study
- hypothesisDecontamination of the implant surface with 35% phosphoric acid during the surgical treatment of peri-implantitis does result in better clinical and microbiological outcome compared to sterile saline
- Healt Condition(s) or Problem(s) studiedPeri-implantitis
- Inclusion criteriaInclusion criteria were:
•≥ 18 years of age;
•at least one endosseous implant with clinical and radiographical signs of peri-implantitis;
•implants were in function for at least two years;
•capable of understanding and providing informed consent.
- Exclusion criteria•Contraindications for the surgical procedures;
•A history of local radiotherapy to the head and neck region;
•Pregnancy and lactation;
•Insuline-dependent diabetes;
•Systemic use of antibiotics during the last 3 months;
•Long-term use of anti-inflammatory drugs;
•Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
•Uncontrolled periodontitis (PPD > 5mm);
•Implants placed in skin grafted areas;
•Implants with bone loss due to other reasons than bacterial infection (e.g. loose screw, inadequate positioning of the implant);
•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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2013
- planned closingdate1-mrt-2016
- Target number of participants27
- InterventionsPeri-implant lesions were treated with resective surgical treatment consisting of apically repositioned flap, bone recontouring and surface debridement and decontamination. After mechanically cleaning, the implant surfaces were treated with 35% phosphoric etching gel
- Primary outcomePercentage of sites with bleeding on probing (% sites BoP) was used as primary clinical outcome variable
- Secondary outcomeSecondary clinical outcome variables were presence of plaque (% sites plaque), suppuration on probing (% sites SoP), mean PPD and radio-graphical marginal bone loss at baseline. Next to this microbiolical parameters were recorded.
- Timepoints- Baseline
- After 3 months
- After 12 months
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESprof. dr. G.M. Raghoebar
- CONTACT for SCIENTIFIC QUERIESprof. dr. G.M. Raghoebar
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsPublications: de Waal YC, Raghoebar GM, Huddleston Slater JJ, Meijer HJ, Winkel EG, van Winkelhoff AJ. Implant decontamination during surgical peri-implantitis treatment: a randomized, double-blind, placebo-controlled trial. J Clin Periodontol. 2013;40:186-195.
- Brief summaryAn effective intervention protocol for treatment of peri-implantitis is not yet available. The objective of this randomized, double-blinded controlled clinical trial was to assess the clinical, microbiological and radiographical effect of decontamination of the implant surface during surgical treatment of peri-implantitis using 35% phosphoric acid or sterile saline.
- Main changes (audit trail)
- RECORD2-jun-2015 - 2-jul-2015

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