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The Gum Irrigator, a new device in the treatment of peri-implantitis


- candidate number28519
- NTR NumberNTR6992
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-feb-2018
- Secondary IDsMETc 2017/644 Universitair Medisch Centrum Groningen (UMCG)
- Public TitleThe Gum Irrigator, a new device in the treatment of peri-implantitis
- Scientific TitleClinical and microbiological effect of submucosal irrigation with The Gum Irrigator for treatment of peri-implantitis.
- ACRONYM
- hypothesisSubmucosal irrigation with the Gum Irrigator will reduce bleeding on probing, pocketdepts and the amount of anearobic bacteria in the non-surgical treatment of peri-implantitis.
- Healt Condition(s) or Problem(s) studiedPeri-implantitis
- Inclusion criteria- The patient is at least 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 more than 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.
- Exclusion criteria- 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)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2018
- planned closingdate1-jan-2021
- Target number of participants24
- InterventionsPeri-implant pockets will be irrigated using the Gum Irrigator 2 times per week during a period of 3 weeks. Patients will receive oral hygiene instructions and the remaining dentition and supramucosal peri-implant areas will be cleaned with conventional methods (curettes and ultrasonic device) prior to submucosal irrigation. Clinical, microbiological and patient-centered measurements will be carried out prior to treatment and 3 months after treatment.
- Primary outcomeThe primary objective is to test the clinical effect of pocket irrigation with a new pocket irrigation device for non-surgical treatment of peri-implantitis.
- Secondary outcomeSecondary objectives are
- to assess the microbiological effect of pocket irrigation with a new pocket irrigation device for non-surgical treatment of peri-implantitis;
- to assess patient-related outcomes.
- Timepoints- Baseline
- 3 months
- Trial web site
- status[default]
- 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)
- Publications
- Brief summaryRationale: Recently, a new apparatus has been developed for irrigation of periodontal and peri-implant pockets. The effectiveness of this Gum Irrigator for treatment of peri-implantitis has yet to be established in clinical studies.
Objective: The aim of the present cohort study is to test the efficacy of pocket irrigation with a new pocket irrigation device for non-surgical treatment of peri-implantitis.
Study design: The present study is a prospective cohort study (pilot study).
Study population: Adult patients (N=24) with at least one endosseous implant in the oral cavity with clinical and radiographical evidence of peri-implantitis will be included.
Intervention: Peri-implant pockets will be irrigated using the Gum Irrigator 2 times per week during a period of 3 weeks. Patients will receive oral hygiene instructions and the remaining dentition and supramucosal peri-implant areas will be cleaned with conventional methods (curettes and ultrasonic device) prior to submucosal irrigation. Clinical, microbiological and patient-centered measurements will be carried out prior to treatment and 3 months after treatment.
Main study parameters/endpoints: The main study parameter is the mean peri-implant bleeding score (%).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will have 6 (short) treatment appointments in addition to the other three appointments. No risks are involved with participation in the study.
- Main changes (audit trail)
- RECORD1-feb-2018 - 8-feb-2018


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