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'A clinical study of the difference in the effect of pocket-irrigation in the treatment of peri-implantitis compared to a conventional therapy, the airflow: a randomized controlled trial'

'A clinical study of the difference in the effect of pocket-irrigation in the treatment of peri-implantitis compared to a conventional therapy, the airflow: a randomized controlled trial' - Pocket irrigation versus airflow in peri-implantitis treatment.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51972
Enrollment
60
Registered
2022-05-18
Start date
2022-09-10
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

infection of the gums surrounding an implant

Interventions

The therapy in groups 1 and 2 consists of treatment of the implants with the Fluxion. The Fluxion is a box-like apparatus consisting of two compartments: one compartiment carrying the fluid which is

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: radiographical boneloss >= 2 mm surrounding an implant presence of bleeding on probing or suppuration age of at least 18 years old

Exclusion criteria

Exclusion criteria: uncontrolled diabetes mellitus usage of prescripted anti-inflammatory medication presence of an allergic reaction to chlorhexidine pregnancy in case of an antibiotics therapy in the last 6 months

Design outcomes

Primary

MeasureTime frame
Peri-implant probing depth (PPD) is the primary parameter.

Secondary

MeasureTime frame
Secondary parameters include the amount of active metalloproteinase-8 proteins (MMP-8), color of the gingiva, plaque by the modified plaque index (MPI), BOP, suppuration, swelling and radiographical bone height in mm. Finally, the participant is asked to indicate the degree of pain during treatment on a numerical scale from 1 (no pain) to 10 (most possible pain). In addition, the following data is collected: gender, age, presence or absence of natural elements, the location of the implants and whether or not to smoke.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)