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

Study Overview
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Brief Summary
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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.

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

Conditions
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Peri-implant Mucositis

Intervention / Treatment
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* Procedure: Modification of the implant supported prostheses in order to facilitate oral hygiene


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mechanical instrumentation and oral hygiene instructions<br> | Procedure: Modification of the implant supported prostheses in order to facilitate oral hygiene<br>* 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<br>|
| Experimental: Modification of the implant supported prostheses<br> | Procedure: Modification of the implant supported prostheses in order to facilitate oral hygiene<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 decontamination |  | 1, 3 and 6 months |