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

Peri-implant Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03540290
• Other study ID #: PER-ECL-2017-01
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2017
• Est. completion date: June 20, 2019

Study information

• Verified date: October 2018
• Source: Universitat Internacional de Catalunya
• Contact: Beatriz de Tapia
• Phone: 0034 646486084
• Email: beatrizdetapia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 20, 2019
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

Intervention

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

Locations

Country	Name	City	State
Spain	Universitat Internacional de Catalunya	Barcelona	Sant Cugat Del Vallès

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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