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

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.

Study Overview

• Status: Unknown
• Conditions: Peri-implant Mucositis
• Intervention / Treatment: Procedure: Modification of the implant supported prostheses in order to facilitate oral hygiene

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Sant Cugat Del Vallès
    • Barcelona, Sant Cugat Del Vallès, Spain, 08195
      • Recruiting
      • Universitat Internacional de Catalunya
      • Contact: Beatriz de Tapia; Phone Number: 0034646486084; Email: beatrizdetapia@gmail.com
      • Contact: Phone Number: 0034646486084; Email: beatrizdetapia@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mechanical instrumentation and oral hygiene instructions	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
Experimental: Modification of the implant supported prostheses	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2017
• Primary Completion (Anticipated): December 12, 2018
• Study Completion (Anticipated): June 20, 2019

Study Registration Dates

• First Submitted: April 27, 2018
• First Submitted That Met QC Criteria: May 27, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis
• Other Study ID Numbers: PER-ECL-2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The results obtained are expected to be published in both national and international journals. In addition, the results will be disseminated national and international scientific events.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No