Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05060601 |
| Other study ID # |
465/20 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2024 |
| Est. completion date |
October 1, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Federico II University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study aims to evaluate the clinical results of non-surgical periodontal therapy
performed with micro-instruments compared to traditional approach (standard curettes) after 6
months of follow-up.
The patients enrolled, subject to written informed consent, will be divided into a Test group
(T) and a Control group (C) through a randomization process. Both groups will be motivated on
the rules of oral hygiene, treated scrupulously and monitored monthly for 6 months, at the
end of which the final data will be collected for statistical processing (in particular by
analyzing the difference between baseline and after 6 months of the parameter "probing depth"
or PD).
Description:
The aim of the study is to evaluate the clinical results of non-surgical periodontal therapy
performed with micro-instruments (micro-curettes) compared to traditional instruments
(standard curettes) after 6 months of follow-up.
The proposed clinical trial will be conducted according to the principles of the Declaration
of Helsinki on experimentation involving human subjects.
All subjects will be recruited from the Area of Odontostomatology - Department of
Neuroscience, Reproductive and Odontostomatological Sciences of the University of Naples
"Federico II".
In a first phase, all patients will be treated with a supragingival scaling session in order
to remove plaque and tartar and it will be provided instructions for a correct oral hygiene.
After 1 week, the clinical parameters (PD, FMPS, FMBS, CAL, REC) will be recorded and the
subjects randomly assigned to the Test (T) or Control (C) group.
In the Test group, after local anesthesia, subgingival mechanical debridement will be
performed using an ultrasonic scaler with specific thin tips and Gracey micro-curette to
minimize soft tissue trauma.
In the Control group, after local anesthesia, debridement will be performed using an
ultrasonic scaler with specific thin tips and standard Gracey curettes.
At the end of the periodontal therapy, a polishing paste will be applied supragingival in
both groups using a rubber cup. An antiseptic therapy based on mouthwash with chlorhexidine
digluconate 0.12% (two rinses a day for the first two weeks) will then be recommended. No
antibiotics will be prescribed.
Patients from both groups will be called up every month for a professional supragingival
cleaning and professional motivation. The final evaluation will be carried out 6 months after
the subgingival treatment.
Data analysis will be performed using statistical software (NCSS-PASS, NCSS, Kaysville, UT).
The patient will be considered as a statistical unit; however an additional analysis based on
the specific dental site will also be performed.
