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| Name | Class |
|---|---|
| CB21 Pharma Ltd. | UNKNOWN |
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The suppression of chronic periodontitis after application of dental gel and toothpaste containing cannabidiol (CBD) will be evaluated.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | Dental gel applied by dentist after oral hygiene (no cannabidiol). Toothpaste for daily use as needed for patients (no cannabidiol). |
|
| CBD group | Experimental | Dental CBD (cannabidiol) gel applied by dentist after oral hygiene. CBD toothpaste for daily use as needed for patients. |
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| Corsodyl group | Active Comparator | Corsodyl dental gel applied by dentist after oral hygiene. Toothpaste for daily use as needed for patients (no cannabidiol). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo dental gel, placebo toothpaste | Combination Product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of cannabidiol on periodontal health (Russell's periodontal index ) of patients with chronic periodontitis | Subjects will undergo the measurement of periodontal index according to A.L. Russell. Data will be collected based on five possible clinical conditions corresponding to the following scoring: Score 0-0.2 (clinical normally supportive tissue) Score 0.3-0.9 (simple gingivitis) Score 1.0-1.9 (beginning destructive periodontal disease) Score 2.0-4.9 (established destructive periodontal disease) Score 5.0-8.0 (terminal disease) Change = (Score after 67 days - Baseline score) | Baseline (0 day) and 67 days |
| Effect of cannabidiol on periodontal health (plaque/gingival indices) of patients with chronic periodontitis | Subjects will undergo the measurement of plaque/gingival indeces according to H. Löe. Data will be collected based on clinical conditions corresponding to the following scoring systems: Plaque index: Score 0 (excellent) Score 0.1-0.9 (good) Score 1.0-1.9 (fair) Score 2.0-3.0 (poor) Gingival index: Score 0.1-1 (mild inflammation) Score 1.1-2 (moderate inflammation) Score 2.1-3 (severe inflammation) Change = (Score after 67 days - Baseline score) | Baseline (0 day) and 67 days |
| Effect of cannabidiol on periodontal health (bleeding) of patients with chronic periodontitis | Subjects will undergo the measurement of gingival bleeding index according to J. Ainamo. Data will be collected based on clinical conditions corresponding to the score related to percentage of bleeding sites: Score 0-1 = 0 %-100 % (bleeding) Change = (Score after 67 days - Baseline score) | Baseline (0 day) and 67 days |
| Effect of cannabidiol on periodontal health (modified gingival index) of patients with chronic periodontitis | Subjects will undergo the measurement of modified gingival index according to R.R. Lobene. Data will be collected based on clinical conditions corresponding to the scoring: Score 0.1-1 (mild inflammation) Score 1.1-2 (moderate inflammation) Score 2.1-3 (severe inflammation) Change = (Score after 67 days - Baseline score) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of cannabidiol on oral microbiota | Evaluation of cannabidiol effect on the composition of periopathogenic bacteria (Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia (Bacteroides forsythus), Treponema denticola, Parvimonas micra, Prevotella intermedia, Fusobacterium nucleatum, Campylobacter rectus, Eubacterium nodatum, Eikenella corrodens, Capnocytophaga sp.) in oral cavity using 16s rRNA sequencing protocol. Semi-quantitative evaluation of bacterial count: Code (-) = no bacteria Code (+) = mild infection Code (++) = moderate infection Code (+++) = severe infection Change = (count after 67 days - Baseline count) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dentistry, Olomouc University Hospital | Olomouc | Czech Republic | CZ- 77900 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32038896 | Background | Stahl V, Vasudevan K. Comparison of Efficacy of Cannabinoids versus Commercial Oral Care Products in Reducing Bacterial Content from Dental Plaque: A Preliminary Observation. Cureus. 2020 Jan 29;12(1):e6809. doi: 10.7759/cureus.6809. | |
| 33526124 | Background | Vasudevan K, Stahl V. Cannabinoids infused mouthwash products are as effective as chlorhexidine on inhibition of total-culturable bacterial content in dental plaque samples. J Cannabis Res. 2020 Jun 23;2(1):20. doi: 10.1186/s42238-020-00027-z. |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| D010518 | Periodontitis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002908 | Chronic Disease |
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| Cannabidiol dental gel, Cannabidiol toothpaste | Combination Product |
|
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| Placebo toothpaste, Corsodyl dental gel | Combination Product |
|
|
| Baseline (0 day) and 67 days |
| Baseline (0 day) and 67 days |
| Cannabidiol oral cavity side effects and gingival immune system | Evaluation of side effects of cannabidiol based on physical examination (photodocumentation) of oral cavity and histopathological analysis of gingiva (interdental papilla), count of plasmocytes, T-lymphocytes, B-lymphocytes and macrophages) will also be performed. Finally, the inflammatory grade according to the number of inflammatory cells per field of view will be evaluated. The intensity of inflammatory response will be classified as: minimal inflammation (number of immune cells up to 60 per field of view), mild inflammation (number of analyzed immune cells in the range of 61 to 100), moderate inflammation (focally confluent sheets of inflammatory cells in the range of 101 to 200), severe inflammation (confluent sheets of inflammatory cells in number more than 200). Change = (count after 37 days - Baseline count) | Baseline (0 day) and 37 days |
| 34562980 | Background | Lowe H, Toyang N, Steele B, Bryant J, Ngwa W, Nedamat K. The Current and Potential Application of Medicinal Cannabis Products in Dentistry. Dent J (Basel). 2021 Sep 10;9(9):106. doi: 10.3390/dj9090106. |
| 13332137 | Background | RUSSELL AL. A system of classification and scoring for prevalence surveys of periodontal disease. J Dent Res. 1956 Jun;35(3):350-9. doi: 10.1177/00220345560350030401. No abstract available. |
| 5237684 | Background | Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available. |
| 1058834 | Background | Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35. |
| 3485495 | Background | Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available. |
| 35332345 | Background | Jirasek P, Jusku A, Simanek V, Frankova J, Storch J, Vacek J. Cannabidiol and periodontal inflammatory disease: A critical assessment. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022 May;166(2):155-160. doi: 10.5507/bp.2022.012. Epub 2022 Mar 21. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |