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NCT Number: NCT06619158

Effectiveness of Zirconia Glaze Removal and Polish in the Treatment of 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Sam Borden Periodontology Specialty Clinic

Winnipeg, Manitoba, R3E 0W2, Canada

Location contact

Daniel Su, DMD

CONTACT

[email protected]

204-789-3426

About this study

The study's objectives are:

  • 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.
  • To determine the effectiveness of submucosal non-surgical hand and powered instrumentation in removal of plaque and calculus.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Crown modification

Procedure

Zirconia glaze removal and polish after crown removal to reduce roughness and prohibit plaque adhesion

Primary outcomes

  1. mBI long term

    Time frame: 12 months following treatment

    modified Bleeding index (mBI) around the implant long term (12 months following treatment)

  2. mBI short term

    Time frame: 60-70 days following treatment

    modified bleeding index (mBI) around the implant short term (60-70 days following treatment)

  3. residual plaque and calculus

    Time frame: baseline

    % of plaque and calculus on the subgingival surface of crown

Secondary outcomes

  1. PI long term

    Time frame: 12 months following treatment

    plaque index (PI) around implant long term

  2. PD short term

    Time frame: 60-70 days following treatment

    probing depth (PD) around implant short term

  3. PD long term

    Time frame: 12 months following treatment

    probing depth (PD) around implant long term

  4. PI short term

    Time frame: 60-70 days following treatment

    plaque index (PI) around implant short term

  5. IL-1β baseline

    Time frame: baseline

    level of IL-1β in the peri-implant crevicular fluid

  6. IL-1β short-term

    Time frame: 60-70 days following treatment

    level of IL-1β in the peri-implant crevicular fluid

  7. IL-1β long-term

    Time frame: 12 months following treatment

    level of IL-1β in the peri-implant crevicular fluid

  8. INF-γ baseline

    Time frame: baseline

    level of INF-γ in the peri-implant crevicular fluid

  9. INF-γ short-term

    Time frame: 60-70 days following treatment

    level of INF-γ in the peri-implant crevicular fluid

  10. INF-γ long-term

    Time frame: 12 months following treatment

    level of INF-γ in the peri-implant crevicular fluid

  11. IL-2 baseline

    Time frame: baseline

    level of IL-2 in peri-implant crevicular fluid

  12. IL-2 short-term

    Time frame: 60-70 days following treatment

    level of IL-2 in the peri-implant crevicular fluid

  13. IL-2 long-term

    Time frame: 12 months following treatment

    level of IL-2 in the peri-implant crevicular fluid

  14. IL-4 baseline

    Time frame: baseline

    level of IL-4 in the peri-implant crevicular fluid

  15. IL-4 short-term

    Time frame: 60-70 days following treatment

    level of peri-implant crevicular fluid

  16. IL-4 long-term

    Time frame: 12 months following treatment

    level of IL-4 in the peri-implant crevicular fluid

  17. IL-6 baseline

    Time frame: baseline

    level of IL-6 in peri-implant crevicular fluid

  18. IL-6 short-term

    Time frame: 60-70 days following treatment

    level of IL-6 in peri-implant crevicular fluid

  19. Il-6 long-term

    Time frame: 12 months following treatment

    level of IL-6 in the peri-implant crevicular fluid

  20. IL-8 baseline

    Time frame: baseline

    level of IL-8 in peri-implant crevicular fluid

  21. IL-8 short-term

    Time frame: 60-70 days following treatment

    level of IL-8 in peri-implant crevicular fluid

  22. IL-8 long-term

    Time frame: 12 months following treatment

    level of IL-8 in peri-implant crevicular fluid

  23. IL-10 baseline

    Time frame: baseline

    level of IL-10 in peri-implant crevicular fluid

  24. IL-10 short term

    Time frame: 60-70 days following treatment

    level of IL-10 in peri-implant crevicular fluid

  25. IL-10 long-term

    Time frame: 12 months following treatment

    level of IL-10 in peri-implant crevicular fluid

  26. TNF-α baseline

    Time frame: baseline

    level of TNF-α in peri-implant crevicular fluid

  27. TNF-α short-term

    Time frame: 60-70 days following treatment

    level of TNF-α in peri-implant crevicular fluid

  28. TNF-α long-term

    Time frame: 12 months following treatment

    level of TNF-α in the peri-implant crevicular fluid

Study contacts

Contact information is provided by the study sponsor or research team.

Chrysi Stavropoulou, DDS, MDent(Perio)

CONTACT

[email protected]

204-272-3075

Daniel Su, DMD

CONTACT

[email protected]

2047893426

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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