Effectiveness of Zirconia Glaze Removal and Polish in the Treatment of Peri-implant Mucositis

September 26, 2024 updated by: Chrysi Stavropoulou, University of Manitoba

Long-term Effectiveness of Zirconia Glaze Removal and Polish As an Adjunct to Non-surgical Therapy in Treatment of Persistent Peri-implant Mucositis

This clinical trial is being conducted to study peri-implant mucositis (inflammation in the gums around dental implant that does not extend into the implant-supporting bone). There are currently no available treatment options able to provide long-term resolution of implant gum inflammation even with our current gold standard treatment of non-surgical cleanings and oral hygiene instructions. The purpose of the study is to compare the effect of crown glaze removal and subsequent polishing in addition to mechanical debridement compared to only mechanical debridement on the implant affected by implant gum inflammation.

In this study, participants will be randomized (put into a group by chance) into one of 2 study groups, groups A and B.

Group A: The implant crown will be cleaned with titanium scaling instruments and powered instruments. The screw-retained crown will be removed and the remaining build-up on the crown will be photographed. The crown will then be sent to a lab technician who will remove the glaze and polish the crown only in the areas that sit under the gums.

Group B: The implant crown will be cleaned with titanium scaling instruments and powered instruments. The screw-retained crown will be removed and the remaining build-up on the crown will be photographed. The crown will then be sent to a lab technician to perform a superficial cleaning only.

In both groups, the crown will be placed back on the implant and customized oral hygiene instructions will be provided.

The study will require four appointment. Appointment #1 is the screening appointment and will take 30-60 minutes. Appointment #2 is when treatment is delivered and will occur within 4 weeks of appointment #1. Appointment #3 is for the short-term follow-up and will occur within 60-70 days of appointment #2. Appointment #4 is for the long-term follow-up and will occur within 12-13 months of appointment #2. All these appointment will be in an outpatient setting at the institutional graduate periodontics clinic.

A total of 2 x-rays will be taken of the implant. One will be taken during appointment #1 to assess the bone around the implant. One will be taken during appointment #2 to ensure that the crown is fully seated when the crown is re-inserted.

The following information will be collected in appointment #1: gum measurements around the implants, how tight the implant contacts adjacent teeth, when the crown was delivered, previous cleanings around the implant, age, sex, gender, previous systemic antibiotic use in the last 2 weeks, smoking habits, presence of diabetes and HbA1C values.

At appointments #2, 3, and 4, the following information will be collected: plaque around implant, gum measurements around implants, previous systemic antibiotic use in the last 2 weeks, smoking habits, presence of diabetes and HbA1C values, gum fluid samples around the implant crown. In appointment #4, additionally, information on how the implant has been cleaned throughout the year will be collected.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study's objectives are:

  1. To determine whether a smooth crown surface (<0.2 μm Ra) can be established in-vitro after glaze removal and polishing based on adapted protocol from Go et al., 2019.
  2. To determine the effectiveness of submucosal non-surgical hand and powered instrumentation in removal of plaque and calculus.
  3. To assess the short- and long-term effectiveness of submucosal zirconia glaze removal and polishing as an adjunct to non-surgical therapy for treatment of persistent peri-implant mucositis. The null hypothesis is that the polishing protocol will not produce any significant differences in the resolution of inflammation compared to crown removal as part of the non-surgical debridement.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0W2
        • Dr Sam Borden Periodontology Specialty Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 1 single screw-retained zirconia glazed implant crown which is in function for at least 1 year, with adequate contact points, submucosal crown margins, no adjacent implants, adequate keratinized tissue (2mm or more), and peri-implant mucositis that persists despite recent (within the past 6 months) non-surgical debridement

Exclusion Criteria:

  • Contraindications to routine dental treatment Open interproximal contacts, splinted implant prosthesis, peri-implant health, peri-implantitis, cemented crown , removable implant prosthesis, recession past the implant platform Systemic antibiotic use within the last 2 weeks heavy smokers (more than 10 cigarettes/day) uncontrolled diabetes (HbA1C more than 7.0%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Crown modification with glaze removal and polish of implant crown
Procedure: Crown modification
Zirconia glaze removal and polish after crown removal to reduce roughness and prohibit plaque adhesion
No Intervention: Group B
No intervention will be applied. The crown will be removed and superficially cleaned

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mBI long term
Time Frame: 12 months following treatment
modified Bleeding index (mBI) around the implant long term (12 months following treatment)
12 months following treatment
mBI short term
Time Frame: 60-70 days following treatment
modified bleeding index (mBI) around the implant short term (60-70 days following treatment)
60-70 days following treatment
residual plaque and calculus
Time Frame: baseline
% of plaque and calculus on the subgingival surface of crown
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PI long term
Time Frame: 12 months following treatment
plaque index (PI) around implant long term
12 months following treatment
PD short term
Time Frame: 60-70 days following treatment
probing depth (PD) around implant short term
60-70 days following treatment
PD long term
Time Frame: 12 months following treatment
probing depth (PD) around implant long term
12 months following treatment
PI short term
Time Frame: 60-70 days following treatment
plaque index (PI) around implant short term
60-70 days following treatment
IL-1β baseline
Time Frame: baseline
level of IL-1β in the peri-implant crevicular fluid
baseline
IL-1β short-term
Time Frame: 60-70 days following treatment
level of IL-1β in the peri-implant crevicular fluid
60-70 days following treatment
IL-1β long-term
Time Frame: 12 months following treatment
level of IL-1β in the peri-implant crevicular fluid
12 months following treatment
INF-γ baseline
Time Frame: baseline
level of INF-γ in the peri-implant crevicular fluid
baseline
INF-γ short-term
Time Frame: 60-70 days following treatment
level of INF-γ in the peri-implant crevicular fluid
60-70 days following treatment
INF-γ long-term
Time Frame: 12 months following treatment
level of INF-γ in the peri-implant crevicular fluid
12 months following treatment
IL-2 baseline
Time Frame: baseline
level of IL-2 in peri-implant crevicular fluid
baseline
IL-2 short-term
Time Frame: 60-70 days following treatment
level of IL-2 in the peri-implant crevicular fluid
60-70 days following treatment
IL-2 long-term
Time Frame: 12 months following treatment
level of IL-2 in the peri-implant crevicular fluid
12 months following treatment
IL-4 baseline
Time Frame: baseline
level of IL-4 in the peri-implant crevicular fluid
baseline
IL-4 short-term
Time Frame: 60-70 days following treatment
level of peri-implant crevicular fluid
60-70 days following treatment
IL-4 long-term
Time Frame: 12 months following treatment
level of IL-4 in the peri-implant crevicular fluid
12 months following treatment
IL-6 baseline
Time Frame: baseline
level of IL-6 in peri-implant crevicular fluid
baseline
IL-6 short-term
Time Frame: 60-70 days following treatment
level of IL-6 in peri-implant crevicular fluid
60-70 days following treatment
Il-6 long-term
Time Frame: 12 months following treatment
level of IL-6 in the peri-implant crevicular fluid
12 months following treatment
IL-8 baseline
Time Frame: baseline
level of IL-8 in peri-implant crevicular fluid
baseline
IL-8 short-term
Time Frame: 60-70 days following treatment
level of IL-8 in peri-implant crevicular fluid
60-70 days following treatment
IL-8 long-term
Time Frame: 12 months following treatment
level of IL-8 in peri-implant crevicular fluid
12 months following treatment
IL-10 baseline
Time Frame: baseline
level of IL-10 in peri-implant crevicular fluid
baseline
IL-10 short term
Time Frame: 60-70 days following treatment
level of IL-10 in peri-implant crevicular fluid
60-70 days following treatment
IL-10 long-term
Time Frame: 12 months following treatment
level of IL-10 in peri-implant crevicular fluid
12 months following treatment
TNF-α baseline
Time Frame: baseline
level of TNF-α in peri-implant crevicular fluid
baseline
TNF-α short-term
Time Frame: 60-70 days following treatment
level of TNF-α in peri-implant crevicular fluid
60-70 days following treatment
TNF-α long-term
Time Frame: 12 months following treatment
level of TNF-α in the peri-implant crevicular fluid
12 months following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: Chrysi Stavropoulou, DDS, MDent(Perio), University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 26, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2024:048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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