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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-10

Study Completion Date

2019-06-20

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.

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Detailed Description

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Conditions

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Peri-implant Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mechanical instrumentation and oral hygiene instructions

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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

Modification of the implant supported prostheses

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No