Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05836298 |
| Other study ID # |
149-22-PO |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2, 2022 |
| Est. completion date |
May 30, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
University of Catania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In light of the controversy that are already approved but that however still exists regarding
the efficacy and influence the management of Periodontitis, the aim of this study was to
evaluates, at 12-months follow-up, the post-treatment clinical and serum parameters in
patients with periodontitis, treated by either Quadrant- Scaling and Root Planing (Q-SRP)
treatment versus conventional Minimally invasive non-surgical therapy (MINST) treatment on
serum C-reactive protein (CRP) and on Lipoprotein-associated phospholipase A2. Patients were
also recalled for supportive periodontal treatment. The main objective was to analyze the
effects of MINST or Q-SRP on clinical parameters and serum CRP and Lipoprotein-associated
phospholipase A2 changes and if high CRP parameters at baseline influenced non surgical
periodontal treatment.
Description:
This trial was conducted in accordance with the World Medical Association's Declaration of
Helsinki of 1975, and reviewed in 2016. The local ethical committee approved the study
protocol and each patient was carefully informed about the possible inherent risks of the
study and provided their informed written consent. Subjects with a diagnosis of periodontitis
were enrolled in this clinical trial. The inclusion criteria were: 1) good condition of
general health, 2) a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging
from 4-6 mm, 3) no involvement of the furcation, 4) a minimum of six teeth per quadrant,
respectively. The exclusion criteria were: 1) periodontal therapy during the last 12 months,
2) assumption of antibiotics during the last 6 months, 3) pregnancy, 4) any systemic
condition which might affect the effects of the study treatment, 5) previous or current
radiation or immunosuppressive therapies, 5) use of mouthwash containing antimicrobials
during the previous 3 months, 6) no use of hormonal contraceptives, 7) medication by
anti-inflammatory and immunosuppressive drugs, 8) previous history of hard-drinking, 9)
smoking, 10) class II and III tooth mobility. The primary outcome was the analysis of NSPT
performed with either MINST or Q-SRP on periodontal parameters and tooth loss and on serum
CRP expression changes between groups after 1- and also 8 years. Furthermore, The secondary
objective was to examine the influence and interaction between NSPT protocol (MINST used as a
reference) and the duration of treatment on serum CRP changes, as well as whether high
baseline CRP levels influenced the efficacy of NSPT after 1-year follow-up. Variations for
PD, CAL, FMBS, FMPS, PISA, Lp-PLA2 and CRP were collected and analyzed at 1, 3-, 6-month and
at 1-year follow-up.
Patients randomly undergo Q-SRP or MINST non surgical periodontal treatment performed in one
session.
All patients underwent an initial session with supragingival debridement. In addition, they
received detailed information about the aetiology of periodontitis and individualized oral
hygiene instructions, which included inter-dental plaque control and toothbrushing using a
modified Bass technique. All participants were provided with the same type of toothbrush and
toothpaste§ as well as interdental brushes‖.
The NSPT was achieved by both hand and ultrasonic instrumentation using a No. 5/6/7 tip
according to operator preference. In both groups, the ultrasonic device was used with
constant water irrigation and with a 20 Hz of frequency at a 60 µn power setting. Patients in
the Q-SRP group received quadrant scaling in four different sessions with an interval of 1
week between each quadrant treatment session. Each patient's first session started in the
upper right maxillary quadrant.
MINST was performed under local anaesthesia through careful subgingival debridement using
ultrasonic scalers with specific thin tips# and Gracey micro-curettes** to minimize the
trauma for the soft tissues. Under 3.5x magnification loupes, supra- and subgingival deposits
were thoroughly debrided. After the operation, there was no subgingival rinsing to promote
the establishment of a stable blood clot.
No mouthwashes, antibiotics or other drugs were prescribed after treatment. At the end of
each treatment session, patients were instructed and motivated to perform personal oral
hygiene. Moreover, oral hygiene procedures were reinforced at 3 and 6 months after treatment.
After the protocol, patients were enrolled in a maintenance program and recalled for clinical
measurements at 1-, 3-, 6-months and 1-year follow-ups. For each patient, a custom-tailored
SPT regimen was prescribed to avoid potential mechanical damage at the surgically treated
region and enhance plaque reduction using a gentle roll technique for toothbrushing and
interproximal cleaning devices.
