CBD Effects on Periodontal Health of Patients With Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The suppression of chronic periodontitis after application of dental gel and toothpaste
      containing cannabidiol (CBD) will be evaluated.
    

Detailed description: 
      Current state of the art: Non-psychotropic cannabinoids (especially cannabidiol, CBD) are
      used as drugs and anti-inflammatory components in a number of medical devices. Their use in
      dentistry (in the form of a full-fledged clinical trial) has not yet been tested. Several
      pharmacological activities have recently been demonstrated for CBD. Its anti-inflammatory and
      anti-bacterial action on oral cavity tissues may be beneficial for patients after dental
      surgery or in patients with periodontal problems. To date, the only registered clinical trial
      with CBD as the active ingredient in toothpaste and mouthwash was conducted at Swinburne
      University of Technology in Melbourne (ANZCTR 2019). The products are tested on men aged from
      18 to 30 years with chronic gingivitis diagnosis.

      Study description: The aim of the study is to evaluate the effect of CBD on the periodontal
      disease. The study will be conducted as a 67-day, monocentric, randomized, interventional,
      and placebo-controlled clinical trial. The effect of dental gel and toothpaste containing CBD
      will be tested. The main evaluated criteria will include a series of periodontal and hygienic
      indices. The study will be carried out in accordance with the Helsinki Declaration of Human
      Rights and CONSORT rules.

      Recruitment and study design: Recruitment (men and women, age 35-65) will be followed by
      several visits:

        1. At the first visit (0 day), patients who meet the inclusion criteria will be documented
           via the set of periodontal, gingival and hygienic indices, microbiological sampling,
           removal of supra/sub-gingival plaque and calculus will be done. Furthermore, a gingival
           sample will be collected for histopathological examination and, hygienic instructions
           will take place.

        2. At the second visit (day 7), the patients will be checked for proper oral hygiene,
           patient's periodontal health will be assessed via the set of periodontal, gingival and
           hygienic indices and CBD dental gel (or identical placebo without CBD) will be applied
           (5 min exposure). Toothpastes containing CBD or placebo will be handed over. The
           patients will use the toothpastes to substitute their normal dental hygiene for the
           duration of the study.

        3. At the third visit (day 22), patient's periodontal health will be assessed via the set
           of periodontal, gingival and hygienic indices and CBD dental gel (or identical placebo
           without CBD) will be applied (5 min exposure).

        4. At the fourth visit (day 37), in case of termination of therapy, gingival samples will
           be collected for histopathological examination. Patient's periodontal health will be
           assessed via the set of periodontal, gingival and hygienic indices. A microbiological
           sample will be collected as well. If the therapy is continued, hygienic re-instruction
           and repeated application of CBD gel will take place (5 min exposure).

        5. During the last visit, patient's periodontal health will be assessed via the set of
           periodontal, gingival and hygienic indices. Microbiological sampling will be performed.
           The total duration of the study was set at 67 days.

      Evaluation of study results: The clinical study will be evaluated based on measurement of
      Russell's periodontal index, plaque index and gingival index, gingival bleeding index and
      modified gingival index. Statistical analysis will be performed in SPSS or STATA software.
      Furthermore, microbiological sampling and gingival samples for histopathological examination
      (count of plasmocytes, T-lymphocytes, B-lymphocytes and macrophages in interdental papilla)
      will be collected.
    

Intervention name(s): placebo dental gel, placebo toothpaste; Cannabidiol dental gel, Cannabidiol toothpaste; Placebo toothpaste, Corsodyl dental gel
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): Placebo dental gel applied by dentist after oral hygiene; without cannabidiol.
Placebo toothpaste; without cannabidiol. For daily use by patient.; Cannabidiol dental gel applied by dentist after oral hygiene; containing 1 % (w/w) cannabidiol.
Cannabidiol toothpaste; containing 1 % (w/w) cannabidiol. For daily use by patient.; Corsodyl dental gel; containing 1 % (w/w) chlorhexidini digluconatis applied by dentist after oral hygiene.
Placebo toothpaste; without cannabidiol. For daily use by patient.
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Periodontitis; Phytocannabinoid; Cannabidiol; Dental gel; Oral microbiota; Inflammation