Impact of C-reactive Protein on Non Surgical Periodontal Treatment
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Non-surgical periodontal treatment
Intervention type(s): Other
Intervention description(s): Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Quadrant Scaling and Root Planing (SRP) or MINST
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Quadrant Scaling and Root Planing (SRP) or MINST treatment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment