An interventional study of Modification of the implant supported prostheses in order to facilitate oral hygiene in Peri-implant Mucositis, sponsored by Universitat Internacional de Catalunya. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-10-24.
Sponsored by Universitat Internacional de Catalunya · Not applicable, Interventional, and Treatment
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.
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's planned enrollment of 48 is close to the median of 50 across 394 interventional studies indexed under Mucositis.
Browse Mucositis studies →Universitat Internacional de Catalunya is the lead sponsor of 144 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
(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.
Procedure: Modification of the implant supported prostheses in order to facilitate oral hygiene
Procedure: Modification 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
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 decontamination
Time frame: 1, 3 and 6 months
Plan to share: Undecided — The results obtained are expected to be published in both national and international journals. In addition, the results will be disseminated national and international scientific events.
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Universitat Internacional de Catalunya