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

U

Universitat Internacional de Catalunya

Status

Unknown

Conditions

Peri-implant Mucositis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03540290
PER-ECL-2017-01

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

Mechanical instrumentation and oral hygiene instructions
Active Comparator group
Treatment:
Procedure: Modification of the implant supported prostheses in order to facilitate oral hygiene
Modification of the implant supported prostheses
Experimental group
Treatment:
Procedure: Modification of the implant supported prostheses in order to facilitate oral hygiene

Trial contacts and locations

1

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Central trial contact

Beatriz de Tapia

Data sourced from clinicaltrials.gov

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