NCT03540290

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

April 27, 2018

Last Update Submit

October 22, 2018

Conditions

Peri-implant Mucositis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Mechanical instrumentation and oral hygiene instructions

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

Modification of the implant supported prostheses

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

Interventions

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

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

Mechanical instrumentation and oral hygiene instructionsModification of the implant supported prostheses

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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).

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Barcelona, Sant Cugat Del Vallès, 08195, Spain

RECRUITING

Central Study Contacts

Beatriz de Tapia

CONTACT

0034 646486084beatrizdetapia@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

April 27, 2018

First Posted

May 30, 2018

Study Start

January 10, 2017

Primary Completion

December 12, 2018

Study Completion

June 20, 2019

Last Updated

October 24, 2018

Record last verified: 2018-10

Locations

ES(1)