Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287957
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2024-02-24
Brief Title:
Chitosan Brushes vs Air-Abrasive Devices on Peri-implant Mucositis Treatment A Randomized Clinical
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
Official Title:
Chitosan Brushes vs Air-Abrasive Devices on Peri-implant Mucositis Treatment A Randomized Clinical
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Bleeding on probing 0123 plaque index - and pocket probing depth will be recorded for each visit Before the procedure the patient will be randomly assigned to one of four groups and records will be kept In the frst visit of the patient necessary actions will be taken according to the group to which the patient is assigned The implant periphery of the patients assigned to the chitosan brush group will be debrided with a chitosan brush with circular movements The implants of the patients assigned to the air abrasive device group will be cleaned in the same way with circular movements The debrided area of both groups will be washed with sterile serum after the treatment Patients will be called at the 2nd 4th and 12th weeks and compared with the records kept
Detailed Description:
Patients with single implants and single cemented crowns with peri-implant mucositis on their posterior teeth Premolars and molars Regular peri-implant mucositis treatment with air-abrasive device and a new method with labrida bioclean brush for cleaning the infection
Experimental procedures and follow-ups Bleeding on probing 0123 plaque index - and pocket probing depth will be recorded for each visit Before the procedure the patient will be randomly assigned to one of four groups and records will be kept In the frst visit of the patient necessary actions will be taken according to the group to which the patient is assigned The implant periphery of the patients assigned to the chitosan brush group will be debrided with a chitosan brush with circular movements The implants of the patients assigned to the air abrasive device group will be cleaned in the same way with circular movements The debrided area of both groups will be washed with sterile serum after the treatment Patients will be called at the 2nd 4th and 12th weeks and compared with the records kept
The number of cases to be taken in total 12 cases was determined as 48 There will be 54-55 cases with 10 drop out share
GPOWER PROTOCOL F tests - ANOVA Repeated measures between factors Analysis A priori Compute required sample size Input Effect size f 04982302 α err prob 005 Power 1-β err prob 095 Number of groups 4 Number of measurements 4 Corr among rep measures 05 Output Noncentrality parameter λ 190643199 Critical F 28164658 Numerator df 30000000 Denominator df 440000000 Total sample size 48 Actual power 09529658 For the results Data will be analyzed with IBM SPSS V23 Repeated measures analysis of variance will be used to analyze quantitative data For multiple comparisons the Bonferroni test will be used Analysis results will be presented as mean and standard deviation for quantitative data and frequency and percentage for categorical data The signifcance level will be taken as p005
Peri-implant mucositis is the last reversible stage before peri-implantitis Treatment of the disease at this stage is very important When treated bone loss around the implant will be prevented and implant survival will be prolonged
Experimental procedures and follow-ups Bleeding on probing 0123 plaque index - and pocket probing depth will be recorded for each visit Before the procedure the patient will be randomly assigned to one of four groups and records will be kept In the frst visit of the patient necessary actions will be taken according to the group to which the patient is assigned The implant periphery of the patients assigned to the chitosan brush group will be debrided with a chitosan brush with circular movements The implants of the patients assigned to the air abrasive device group will be cleaned in the same way with circular movements The debrided area of both groups will be washed with sterile serum after the treatment Patients will be called at the 2nd 4th and 12th weeks and compared with the records kept
The number of cases to be taken in total 12 cases was determined as 48 There will be 54-55 cases with 10 drop out share
GPOWER PROTOCOL F tests - ANOVA Repeated measures between factors Analysis A priori Compute required sample size Input Effect size f 04982302 α err prob 005 Power 1-β err prob 095 Number of groups 4 Number of measurements 4 Corr among rep measures 05 Output Noncentrality parameter λ 190643199 Critical F 28164658 Numerator df 30000000 Denominator df 440000000 Total sample size 48 Actual power 09529658 For the results Data will be analyzed with IBM SPSS V23 Repeated measures analysis of variance will be used to analyze quantitative data For multiple comparisons the Bonferroni test will be used Analysis results will be presented as mean and standard deviation for quantitative data and frequency and percentage for categorical data The signifcance level will be taken as p005
Peri-implant mucositis is the last reversible stage before peri-implantitis Treatment of the disease at this stage is very important When treated bone loss around the implant will be prevented and implant survival will be prolonged
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?:
False
Is an FDA AA801 Violation?:
None