Oral Hygiene and Systemic Inflammation (Perio-Hygiene 1.0)
Condition: Gingivitis
MeSH terms: Gingivitis; Inflammation
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the impact of oral hygiene changes (drastic plaque
      and gingival inflammation reduction) on markers of systemic inflammation and indicators of
      oral health related quality of life and other aspects related to overall well-being.

      The primary objective is to assess a possible reduction of systemic inflammation as measured
      through blood bio-markers one month after drastic changes of plaque accumulation. As primary
      outcome measure, the level of high-sensitive C-reactive protein (hs-CRP) will be assessed.
    

Detailed description: 
      This study is a single-center, 2 arms, randomized parallel group double-blind clinical trial
      with one month follow-up, involving patients with no conditions capable of alteration of the
      systemic inflammatory levels as measured by C-reactive protein (CRP).

      Screening will be actuated through a two-step procedure: a careful dental and medical
      examination will be collected. Subjects with negative history for the conditions tested will
      undergo blood testing to further confirm the anamnestic findings. Center investigators will
      document in a screening log reasons for ineligibility or exclusion of subjects. Thus,
      subjects fulfilling the inclusion criteria will be invited to participate. Clinical center
      will enroll probands, assigning a unique study subject number and allocating an opaque
      randomization envelope.

      Informed consent will be obtained by the center investigator who will describe the objectives
      of the study, the alternatives and risks associated with study participation as well as the
      possibility to withdraw at any time without compromise for the treatment. Consent procedures
      and documentation of consent will be performed at the screening visit in the national
      language of the patient and in accordance with local best practice and regulations.

      Patients included in the study will undergo a thorough clinical examination aiming at
      collecting all the data desired (oral and systemic parameters, blood sampling and
      questionnaires fulfilment). After examinations, the opaque envelope with associated the code
      of the patient will be opened identifying whether the patient enters Test or Control group.

      Patients will also receive a session of professional supragingival scaling and polishing:
      instrumentation will be performed by a trained dental hygienist/periodontist with great care
      in performing exclusively coronal maneuver. No instrumentation or exploring of the gingival
      crevice/ sulcus will be performed.

      Subjects in the Test group will receive a thorough session of oral hygiene instruction (OHI)
      and a full oral hygiene kit.

      OHI will be given focusing on electric toothbrushing as first instance and subsequently
      focusing on interdental cleaning. OHI will be delivered by trained dental
      hygienist/periodontist.

      OHI will be given directly on the patient's mouth. In the first phase the clinician will
      explain and show the technique to the patient. The patient will be then invited to perform
      the technique. Each phase will be assisted and monitored by the clinician. Overall, this
      sequence may be repeated as many times as the clinician would deem appropriate.

      Subjects in the control group will be invited to attend another examination in 4 weeks (T28)

      Every week, included subjects in the Test group will attend session of OHI re-enforcement and
      plaque control in order to achieve optimal plaque control. Ideally a value below 20% should
      be aimed as shown already to be consistent with findings from our research group.

      Patients of both groups will undergo clinical examinations, questionnaires and blood
      withdrawal. The clinical examinations will be performed by examiners blind to group
      allocation. Participants will be asked by the study coordinators not to disclose to the
      examiners whether they belong to Test or Control group.

      Any periodontal treatment, or professional scaling will be forbidden after the inclusion
      (T0). For patient allocated in the Test group any pharmacological treatment prescription, or
      any devices administration different from this study protocol guidelines will be prohibited.
      In particular, if the patients, in both test or control group, will have to undergo treatment
      capable of influencing CRP (statins) this will be highlighted and the patient excluded from
      the study. If withdrawal for prohibited intervention occurs, a new patient enrolment will be
      activated.

      Individuals will be free to quit the study at any time. Patients who will fail to comply with
      T28 VISIT will be excluded from the study.
    

Intervention name(s): Oral Hygiene Instruction (OHI); Professional supragingival scaling and polishing
Intervention type(s): Behavioral; Procedure
Intervention description(s): OHI will be given focusing on electric toothbrushing as first instance and subsequently focusing on interdental cleaning. OHI will be delivered by trained dental hygienist/periodontist. In the first phase the clinician will explain and show the technique to the patient. The patient will be then invited to perform the technique. Each phase will be assisted and monitored by the clinician. Overall, this sequence may be repeated as many times as the clinician would deem appropriate.; Patients will receive a session of professional supragingival scaling and polishing, that consists of removal of dental plaque and dental calculus from the surface of a tooth, with great care in performing exclusively coronal maneuver. No instrumentation or exploring of the gingival crevice/ sulcus will be performed. Instrumentation will be performed by a trained dental hygienist/periodontist.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-centre randomized, parallel design, clinical trial with a 1-month follow-up
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment