Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619158
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Effectiveness of Zirconia Glaze Removal and Polish in the Treatment of Peri-implant Mucositis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Long-term Effectiveness of Zirconia Glaze Removal and Polish As an Adjunct to Non-surgical Therapy in Treatment of Persistent Peri-implant Mucositis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
The studys objectives are
1 To determine whether a smooth crown surface lt02 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
1 To determine whether a smooth crown surface lt02 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None