|- candidate number||28519|
|- NTR Number||NTR6992|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-feb-2018|
|- Secondary IDs||METc 2017/644 Universitair Medisch Centrum Groningen (UMCG)|
|- Public Title||The Gum Irrigator, a new device in the treatment of peri-implantitis|
|- Scientific Title||Clinical and microbiological effect of submucosal irrigation with The Gum Irrigator for treatment of peri-implantitis.|
|- hypothesis||Submucosal 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) studied||Peri-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);
- 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 received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mrt-2018|
|- planned closingdate||1-jan-2021|
|- Target number of participants||24|
|- Interventions||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. |
|- Primary outcome||The 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 outcome||Secondary 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|
|- CONTACT FOR PUBLIC QUERIES||prof. dr. G.M. Raghoebar|
|- CONTACT for SCIENTIFIC QUERIES||prof. dr. G.M. Raghoebar|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Brief summary||Rationale: 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)|
|- RECORD||1-feb-2018 - 8-feb-2018|