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Treatment of Peri-implant Mucositis by Means of Implant Decontamination and Modification of the Implant Supported-prosthesis

Treatment of Peri-implant Mucositis by Means of Implant Decontamination and Modification of the Implant Supported-prosthesis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03540290
Enrollment
48
Registered
2018-05-30
Start date
2017-01-10
Completion date
2019-06-20
Last updated
2018-10-24

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

Conditions

Peri-implant Mucositis

Brief summary

To test the modification of the implant prosthesis, in order to facilitate access to biofilm control, in combination with decontamination of the implant surface by means of an ultrasonic device with a plastic tip and plastic curettes, in comparison with the decontamination of the implant surface by means of an ultrasonic device with a plastic tip and plastic curettes, and no modification of the implant prosthesis.

Interventions

PROCEDUREModification of the implant supported prostheses in order to facilitate oral hygiene

Peri-implant mucositis will be treated by individualized oral hygiene instructions and decontamination of the implant surface by ultrasonic device with a plastic tip and plastic curettes plus the modification of the implant prosthesis in order to facilitate oral hygiene access

Sponsors

Universitat Internacional de Catalunya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* (1) Presence of, at least, one titanium implant exhibiting peri-implant mucositis, defined as bleeding on gentle probing (0.15 N) in at least one peri-implant site. (2) No signs of loss of supporting bone after initial bone remodelling. In cases where baseline radiograph is available, it will be used for comparison, otherwise a maximum of 2 mm of crestal bone loss will be accepted (5). (3) Single tooth and bridgework restoration with an inappropriate prosthesis design or contour which difficult oral hygiene access (overcontoured prosthesis, prostheses presenting closed embrasures, an abrupt emergence profile or excessive buccal flanges). (4) Presence of \>1 mm of keratinized peri-implant mucosa. (5) A good level of oral hygiene, defined as an O'Leary et al. plaque index \<25% (16). (6) Absence of systemic diseases that could influence the outcome of the therapy (i.e. controlled diabetes, with HbA1c\<7, patients will be included). (7) Non-smoker or light smoking status in smokers (\<10 cigarettes/day).

Exclusion criteria

* (1) Untreated periodontal conditions. (2) Pregnant or lactating women. (3) Patients who received systemic antibiotics in the last 3 months. (4) Patients who received treatment of PM in the past 3 months. (5) Patients receiving corticoids or medications known to have effect on gingival growth i.e. calcium channel antagonists, immunosuppressants or antiepileptic drugs. In those cases diagnosed with peri-implantitis, individualized treatment will be provided, apart from the present study.

Design outcomes

Primary

MeasureTime frame
Evaluate modified sulcus Bleeding Index changes at 3 and 6 months, by the modification of the implant prosthesis in order to facilitate oral hygiene, hygiene instructions and surface decontamination1, 3 and 6 months

Countries

Spain

Contacts

Primary ContactBeatriz de Tapia
beatrizdetapia@gmail.com0034 646486084

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026