Dr Sam Borden Periodontology Specialty Clinic
Winnipeg, Manitoba, R3E 0W2, Canada
NCT Number: NCT06619158
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Winnipeg, Manitoba, R3E 0W2, Canada
The study's objectives are:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Zirconia glaze removal and polish after crown removal to reduce roughness and prohibit plaque adhesion
Time frame: 12 months following treatment
modified Bleeding index (mBI) around the implant long term (12 months following treatment)
Time frame: 60-70 days following treatment
modified bleeding index (mBI) around the implant short term (60-70 days following treatment)
Time frame: baseline
% of plaque and calculus on the subgingival surface of crown
Time frame: 12 months following treatment
plaque index (PI) around implant long term
Time frame: 60-70 days following treatment
probing depth (PD) around implant short term
Time frame: 12 months following treatment
probing depth (PD) around implant long term
Time frame: 60-70 days following treatment
plaque index (PI) around implant short term
Time frame: baseline
level of IL-1β in the peri-implant crevicular fluid
Time frame: 60-70 days following treatment
level of IL-1β in the peri-implant crevicular fluid
Time frame: 12 months following treatment
level of IL-1β in the peri-implant crevicular fluid
Time frame: baseline
level of INF-γ in the peri-implant crevicular fluid
Time frame: 60-70 days following treatment
level of INF-γ in the peri-implant crevicular fluid
Time frame: 12 months following treatment
level of INF-γ in the peri-implant crevicular fluid
Time frame: baseline
level of IL-2 in peri-implant crevicular fluid
Time frame: 60-70 days following treatment
level of IL-2 in the peri-implant crevicular fluid
Time frame: 12 months following treatment
level of IL-2 in the peri-implant crevicular fluid
Time frame: baseline
level of IL-4 in the peri-implant crevicular fluid
Time frame: 60-70 days following treatment
level of peri-implant crevicular fluid
Time frame: 12 months following treatment
level of IL-4 in the peri-implant crevicular fluid
Time frame: baseline
level of IL-6 in peri-implant crevicular fluid
Time frame: 60-70 days following treatment
level of IL-6 in peri-implant crevicular fluid
Time frame: 12 months following treatment
level of IL-6 in the peri-implant crevicular fluid
Time frame: baseline
level of IL-8 in peri-implant crevicular fluid
Time frame: 60-70 days following treatment
level of IL-8 in peri-implant crevicular fluid
Time frame: 12 months following treatment
level of IL-8 in peri-implant crevicular fluid
Time frame: baseline
level of IL-10 in peri-implant crevicular fluid
Time frame: 60-70 days following treatment
level of IL-10 in peri-implant crevicular fluid
Time frame: 12 months following treatment
level of IL-10 in peri-implant crevicular fluid
Time frame: baseline
level of TNF-α in peri-implant crevicular fluid
Time frame: 60-70 days following treatment
level of TNF-α in peri-implant crevicular fluid
Time frame: 12 months following treatment
level of TNF-α in the peri-implant crevicular fluid
Contact information is provided by the study sponsor or research team.
Chrysi Stavropoulou, DDS, MDent(Perio)
CONTACT
Daniel Su, DMD
CONTACT
University of Manitoba
Other
Long-term Effectiveness of Zirconia Glaze Removal and Polish As an Adjunct to Non-surgical Therapy in Treatment of Persistent Peri-implant Mucositis
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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