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

Not Applicable

• Conditions: Peri-implant Mucositis
• Interventions: Procedure: Modification of the implant supported prostheses in order to facilitate oral hygiene

• Registration Number: NCT03540290
• Lead Sponsor: Universitat Internacional de Catalunya

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-10
• Study First Submitted: 2018-04-27
• Study First Submitted QC: 2018-05-27
• Study First Posted: 2018-05-30
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-24
• Primary Completion: 2018-12-12
• Study Completion: 2019-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modification of the implant supported prostheses	Modification of the implant supported prostheses in order to facilitate oral hygiene	-
Mechanical instrumentation and oral hygiene instructions	Modification of the implant supported prostheses in order to facilitate oral hygiene	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Barcelona, Sant Cugat Del Vallès, Spain