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.
ID
Bron
Aandoening
Peri-implantitis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
- Baseline
- 3 months
Onderzoeksproduct en/of interventie
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.
Publiek
Department of Oral Sugery
P.O. Box 30001
G.M. Raghoebar
Groningen 9700 RB
The Netherlands
+31(0)50 3613186
g.m.raghoebar@kchir.umcg.nl
Wetenschappelijk
Department of Oral Sugery
P.O. Box 30001
G.M. Raghoebar
Groningen 9700 RB
The Netherlands
+31(0)50 3613186
g.m.raghoebar@kchir.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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)
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6806 |
| NTR-old | NTR6992 |
| Ander register | Universitair Medisch Centrum Groningen (UMCG) : METc 2017/644 |