Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06287957 |
| Other study ID # |
IU-DHF-AG-01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2024 |
| Est. completion date |
February 15, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Istanbul University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Bleeding on probing (0,1,2,3), 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.
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 (0,1,2,3), 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 = 0.4982302 α err prob = 0.05 Power (1-β
err prob) = 0.95 Number of groups = 4 Number of measurements = 4 Corr among rep measures =
0.5 Output: Noncentrality parameter λ = 19.0643199 Critical F = 2.8164658 Numerator df =
3.0000000 Denominator df = 44.0000000 Total sample size = 48 Actual power = 0.9529658 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 p<0.05.
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.
