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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.
The study's objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Crown modification with glaze removal and polish of implant crown |
|
| Group B | No Intervention | No intervention will be applied. The crown will be removed and superficially cleaned |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crown modification | Procedure | Zirconia glaze removal and polish after crown removal to reduce roughness and prohibit plaque adhesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| mBI long term | modified Bleeding index (mBI) around the implant long term (12 months following treatment) | 12 months following treatment |
| mBI short term | modified bleeding index (mBI) around the implant short term (60-70 days following treatment) | 60-70 days following treatment |
| residual plaque and calculus | % of plaque and calculus on the subgingival surface of crown | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| PI long term | plaque index (PI) around implant long term | 12 months following treatment |
| PD short term | probing depth (PD) around implant short term |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chrysi Stavropoulou, DDS, MDent(Perio) | Contact | 204-272-3075 | chrysi.stavropoulou@umanitoba.ca | |
| Daniel Su, DMD | Contact | 2047893426 | sud4@myumanitoba.ca |
| Name | Affiliation | Role |
|---|---|---|
| Chrysi Stavropoulou, DDS, MDent(Perio) | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Sam Borden Periodontology Specialty Clinic | Winnipeg | Manitoba | R3E 0W2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27975061 | Background | Yu P, Wang C, Zhou J, Jiang L, Xue J, Li W. Influence of Surface Properties on Adhesion Forces and Attachment of Streptococcus mutans to Zirconia In Vitro. Biomed Res Int. 2016;2016:8901253. doi: 10.1155/2016/8901253. Epub 2016 Nov 15. | |
| 24492105 | Background | Tete S, Zizzari VL, Borelli B, De Colli M, Zara S, Sorrentino R, Scarano A, Gherlone E, Cataldi A, Zarone F. Proliferation and adhesion capability of human gingival fibroblasts onto zirconia, lithium disilicate and feldspathic veneering ceramic in vitro. Dent Mater J. 2014;33(1):7-15. doi: 10.4012/dmj.2013-185. |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| 60-70 days following treatment |
| PD long term | probing depth (PD) around implant long term | 12 months following treatment |
| PI short term | plaque index (PI) around implant short term | 60-70 days following treatment |
| IL-1β baseline | level of IL-1β in the peri-implant crevicular fluid | baseline |
| IL-1β short-term | level of IL-1β in the peri-implant crevicular fluid | 60-70 days following treatment |
| IL-1β long-term | level of IL-1β in the peri-implant crevicular fluid | 12 months following treatment |
| INF-γ baseline | level of INF-γ in the peri-implant crevicular fluid | baseline |
| INF-γ short-term | level of INF-γ in the peri-implant crevicular fluid | 60-70 days following treatment |
| INF-γ long-term | level of INF-γ in the peri-implant crevicular fluid | 12 months following treatment |
| IL-2 baseline | level of IL-2 in peri-implant crevicular fluid | baseline |
| IL-2 short-term | level of IL-2 in the peri-implant crevicular fluid | 60-70 days following treatment |
| IL-2 long-term | level of IL-2 in the peri-implant crevicular fluid | 12 months following treatment |
| IL-4 baseline | level of IL-4 in the peri-implant crevicular fluid | baseline |
| IL-4 short-term | level of peri-implant crevicular fluid | 60-70 days following treatment |
| IL-4 long-term | level of IL-4 in the peri-implant crevicular fluid | 12 months following treatment |
| IL-6 baseline | level of IL-6 in peri-implant crevicular fluid | baseline |
| IL-6 short-term | level of IL-6 in peri-implant crevicular fluid | 60-70 days following treatment |
| Il-6 long-term | level of IL-6 in the peri-implant crevicular fluid | 12 months following treatment |
| IL-8 baseline | level of IL-8 in peri-implant crevicular fluid | baseline |
| IL-8 short-term | level of IL-8 in peri-implant crevicular fluid | 60-70 days following treatment |
| IL-8 long-term | level of IL-8 in peri-implant crevicular fluid | 12 months following treatment |
| IL-10 baseline | level of IL-10 in peri-implant crevicular fluid | baseline |
| IL-10 short term | level of IL-10 in peri-implant crevicular fluid | 60-70 days following treatment |
| IL-10 long-term | level of IL-10 in peri-implant crevicular fluid | 12 months following treatment |
| TNF-α baseline | level of TNF-α in peri-implant crevicular fluid | baseline |
| TNF-α short-term | level of TNF-α in peri-implant crevicular fluid | 60-70 days following treatment |
| TNF-α long-term | level of TNF-α in the peri-implant crevicular fluid | 12 months following treatment |
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