CBD Effects on Periodontal Health of Patients With Chronic Periodontitis (Stoma-CBD)

Palacky University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Periodontitis

Treatments: Combination Product: Cannabidiol dental gel, Cannabidiol toothpaste; Combination Product: placebo dental gel, placebo toothpaste; Combination Product: Placebo toothpaste, Corsodyl dental gel

Study type: Interventional

Funder types: Other

Identifiers

NCT05498012

#3620

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic periodontitis
• Age 35-65 years
• Number of native teeth 16 or 16+
• Signed informed consent
• Without physical or mental impairment

Exclusion criteria

• Chronic diseases (diabetes mellitus, oncological diseases)
• Increased bleeding (medications - anticoagulants, antiplatelet agents, bleeding diathesis)
• Pregnant and lactating women
• Tabacco smokers
• Users of cannabis or cannabis products
• ATB treatment during the last 3 months
• Patient with removable prosthesis
• Parallel participation in another clinical trial

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

Dental gel applied by dentist after oral hygiene (no cannabidiol). Toothpaste for daily use as needed for patients (no cannabidiol).

Treatment:

Combination Product: placebo dental gel, placebo toothpaste

CBD group

Experimental group

Description:

Dental CBD (cannabidiol) gel applied by dentist after oral hygiene. CBD toothpaste for daily use as needed for patients.

Treatment:

Combination Product: Cannabidiol dental gel, Cannabidiol toothpaste

Corsodyl group

Active Comparator group

Description:

Corsodyl dental gel applied by dentist after oral hygiene. Toothpaste for daily use as needed for patients (no cannabidiol).

Treatment:

Combination Product: Placebo toothpaste, Corsodyl dental gel