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

Clinical and microbiological effect of submucosal irrigation with The Gum Irrigator for treatment of peri-implantitis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21056

Enrollment

Registered

2018-02-01

Start date

2018-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-implantitis

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

Eligibility

Inclusion criteria

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

Exclusion criteria: - Medical and general contraindications for the procedures; - A history of local radiotherapy to the head and neck region; - Uncontrolled diabetes (HbA1c 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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Contacts

Public ContactG.M. Raghoebar

University Medical Center Groningen (UMCG) Department of Oral Sugery P.O. Box 30001

g.m.raghoebar@kchir.umcg.nl+31(0)50 3613186

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)