Ignite Creation Date:
2024-05-06 @ 10:38 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03316937
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2017-10-17
Brief Title:
Comparison of the Effect of Teflon vs Non-Teflon Hand Scalers in the Maintenance of Peri-Implant Tissue
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Comparison of the Effect of Teflon vs Non-Teflon Hand Scalers in the Maintenance of Peri-Implant Tissue A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The buccal and lingual surface of the 23 participants crowns will be randomly assigned to receive scaling and root planing with either Teflon scalers or non-Teflon scalers after implant crown delivery Each patient will act as their own control
Patients will receive scaling and root planing at 3 6 9 and 12 months by a calibrated dental hygienist All surfaces of the implant will be debrided for 1 minute using a transversal movement Each patient will receive oral hygiene instructions by the hygienist at the end of each maintenance therapy appointment The participants will be instructed to use a Modified Stillman brushing technique twice per day and cross shoe shine flossing motion once per day Each patient will be provided with a three-month home care kit with dental aids These aids will consist of toothpaste a toothbrush and implant floss
Measurements will be taken at 0 3 6 9 and 12 months by a calibrated periodontal resident The parameters assessed at the implant site and patient level will be modified plaque index IPI by Mombelli modified gingival index IBOP by Mombelli implant probing depths PD at six sites presence of keratinized gingiva KT recession REC Full mouth plaque index FPI and Full mouth bleeding on probing FBOP
The Peri-implant Crevicular Fluid will be collected at 0 3 and 12 months by isolating the implant site from saliva and introducing Periopaper strips into the buccal mesial distal and lingual sites of the implant sulcus for 30 seconds The strips will be placed in a sealed Eppendorf tubes and transported by portable freezer to the laboratory where they will be stored at -86 degrees Celsius The Periopaper samples will be treated for the detection and quantification of the following cytokines Interleukin-2 Interleukin-4 Interleukin-6 Interleukin-8 Interleukin-10 Tumor Necrosis Factor alpha and Interferon gamma
Periapicals will be taken at baseline and 12 months All radiographs will be standardized
After 12 months the implant crown will be removed and the implant crowns surface alterations will be evaluated using atomic force microscopy AFM using the RA or average roughness and the RZ or mean roughness depth scores The implant crown surface will then be repolishedreglazed and delivered back to the patients mouth Crowns will be evaluated before delivery to determine adequate level of smoothness
Based on the presence of cytokines in the Peri-implant Crevicular Fluid the degree of surface alterations the modified plaque index implant probing depths full mouth plaque index and full mouth bleeding on probing we can determine if scratching affects the inflammation around the screw retained dental implant
Patients will receive scaling and root planing at 3 6 9 and 12 months by a calibrated dental hygienist All surfaces of the implant will be debrided for 1 minute using a transversal movement Each patient will receive oral hygiene instructions by the hygienist at the end of each maintenance therapy appointment The participants will be instructed to use a Modified Stillman brushing technique twice per day and cross shoe shine flossing motion once per day Each patient will be provided with a three-month home care kit with dental aids These aids will consist of toothpaste a toothbrush and implant floss
Measurements will be taken at 0 3 6 9 and 12 months by a calibrated periodontal resident The parameters assessed at the implant site and patient level will be modified plaque index IPI by Mombelli modified gingival index IBOP by Mombelli implant probing depths PD at six sites presence of keratinized gingiva KT recession REC Full mouth plaque index FPI and Full mouth bleeding on probing FBOP
The Peri-implant Crevicular Fluid will be collected at 0 3 and 12 months by isolating the implant site from saliva and introducing Periopaper strips into the buccal mesial distal and lingual sites of the implant sulcus for 30 seconds The strips will be placed in a sealed Eppendorf tubes and transported by portable freezer to the laboratory where they will be stored at -86 degrees Celsius The Periopaper samples will be treated for the detection and quantification of the following cytokines Interleukin-2 Interleukin-4 Interleukin-6 Interleukin-8 Interleukin-10 Tumor Necrosis Factor alpha and Interferon gamma
Periapicals will be taken at baseline and 12 months All radiographs will be standardized
After 12 months the implant crown will be removed and the implant crowns surface alterations will be evaluated using atomic force microscopy AFM using the RA or average roughness and the RZ or mean roughness depth scores The implant crown surface will then be repolishedreglazed and delivered back to the patients mouth Crowns will be evaluated before delivery to determine adequate level of smoothness
Based on the presence of cytokines in the Peri-implant Crevicular Fluid the degree of surface alterations the modified plaque index implant probing depths full mouth plaque index and full mouth bleeding on probing we can determine if scratching affects the inflammation around the screw retained dental implant
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None