Zirconia Glaze Removal and Polish for Peri-Implant Mucositis

Overseen By Daniel Su, DMD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Must not be taking: Antibiotics

Disqualifiers: Heavy smokers, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

44 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have used systemic antibiotics in the last 2 weeks, you may not be eligible to participate.

What data supports the effectiveness of the treatment Zirconia Glaze Removal and Polish for Peri-Implant Mucositis?

Research suggests that enhancing the smoothness of zirconia surfaces can reduce bacterial adhesion, which is important in preventing peri-implant mucositis from worsening. Additionally, methods like glycine powder air-polishing have shown potential in effectively removing biofilms, which may improve treatment outcomes for peri-implant mucositis. ^{1 2 3 4 5}

Is zirconia glaze removal and polish safe for humans?

Zirconia ceramics, used in dental and orthopedic applications, are generally safe for humans, showing high biocompatibility (compatibility with living tissue) and low wear rates. Studies indicate that zirconia is stable and well-tolerated by oral tissues, with only minor inflammation observed in some cases. ^{6 7 8 9 10}

How does the Zirconia Glaze Removal and Polish treatment differ from other treatments for peri-implant mucositis?

Zirconia Glaze Removal and Polish is unique because it focuses on the mechanical alteration of the implant surface, which may help reduce bacterial accumulation and inflammation, unlike other treatments that often rely on chemical agents or air-polishing techniques. ^{5 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Chrysi Stavropoulou, DDS, MDent(Perio)

Principal Investigator

University of Manitoba

Eligibility Criteria

This trial is for individuals with peri-implant mucositis, which is gum inflammation around dental implants. Participants should have this condition but not the more severe peri-implantitis affecting bone. They must be available for four appointments and willing to follow oral hygiene instructions.

Inclusion Criteria

I have a zirconia implant crown for over a year with healthy gums around it.

Exclusion Criteria

I have gaps between my teeth.

My diabetes is not under control (HbA1C over 7.0%).

Cemented crown

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive either crown glaze removal and polish or superficial cleaning of the implant crown

4 weeks

1 visit (in-person)

Short-term Follow-up

Participants are monitored for short-term effectiveness of the treatment

8-10 weeks

1 visit (in-person)

Long-term Follow-up

Participants are monitored for long-term effectiveness of the treatment

12-13 months

1 visit (in-person)

Treatment Details

Interventions

• Zirconia Glaze Removal and Polish

Trial Overview The study compares two treatments: Group A receives crown cleaning plus glaze removal and polishing under the gums; Group B gets only crown cleaning. Both groups will receive mechanical debridement and customized oral hygiene advice.

Participant Groups

Group I: Group A Experimental Treatment 1 Intervention

Crown modification with glaze removal and polish of implant crown

Group II: Group B Active Control 1 Intervention

No intervention will be applied. The crown will be removed and superficially cleaned

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Adjunctive effect of modifying the implant-supported prosthesis in the treatment of peri-implant mucositis. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Glow Discharge Plasma Treatment on Zirconia Surface to Enhance Osteoblastic-Like Cell Differentiation and Antimicrobial Effects. [2020]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

The effects of physical decontamination methods on zirconia implant surfaces: a systematic review. [2021]

4. Denmark pubmed.ncbi.nlm.nih.gov

Effect of cleaning methods on retentive values of saliva-contaminated implant-supported zirconia copings. [2018]

5. Denmark pubmed.ncbi.nlm.nih.gov

Effect of glycine powder air-polishing as an adjunct in the treatment of peri-implant mucositis: a pilot clinical trial. [2014]

6. China pubmed.ncbi.nlm.nih.gov

[Clinical evaluation of the zirconia all ceramic crowns in 40 consecutive patients]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Wear Behavior of the Human Enamel Antagonist to Different Glazed Zirconia. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Zirconia as a sliding material: histologic, laboratory, and clinical data. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Consecutive case series of monolithic and minimally veneered zirconia restorations on teeth and implants: up to 68 months. [2022]

10. Romania pubmed.ncbi.nlm.nih.gov

A microscopic insight of the morphological changes induced by dental zirconia prosthetic structures. [2020]

11. China pubmed.ncbi.nlm.nih.gov

[Efficacy of subgingival glycine air polishing on the treatment of moderate-mild peri-implantitis]. [2019]

12. Denmark pubmed.ncbi.nlm.nih.gov

Management of peri-implant mucositis and peri-implantitis. [2022]

13. India pubmed.ncbi.nlm.nih.gov

Efficacy of implantoplasty in management of peri-implantitis: A systematic review. [2023]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Ozonized Hydrogels vs. 1% Chlorhexidine Gel for the Clinical and Domiciliary Management of Peri-Implant Mucositis: A Randomized Clinical Trial. [2023]