Back to results

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

Primary Purpose

Peri-implant Mucositis

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Peri-implant Mucositis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Universitat Internacional de CatalunyaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mechanical instrumentation and oral hygiene instructions

Modification of the implant supported prostheses

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03540290

First Posted

April 27, 2018

Last Updated

October 22, 2018

Sponsor

Universitat Internacional de Catalunya

1. Study Identification

Unique Protocol Identification Number

NCT03540290

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 10, 2017 (Actual)

Primary Completion Date

December 12, 2018 (Anticipated)

Study Completion Date

June 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitat Internacional de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peri-implant Mucositis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mechanical instrumentation and oral hygiene instructions

Arm Type

Active Comparator

Arm Title

Modification of the implant supported prostheses

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

1, 3 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Beatriz de Tapia

Phone

0034 646486084

beatrizdetapia@gmail.com

Facility Information:

Facility Name

Universitat Internacional de Catalunya

City

Barcelona

State/Province

Sant Cugat Del Vallès

ZIP/Postal Code

08195

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beatriz de Tapia

Phone

0034646486084

beatrizdetapia@gmail.com

Phone

0034646486084

beatrizdetapia@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs