CBD Effects on Periodontal Health of Patients With Chronic Periodontitis

NCT05498012 | Completed Phase 1

• 1 other identifier: #3620
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Periodontitis

Keywords

Periodontitis; Phytocannabinoid; Cannabidiol; Dental gel; Oral microbiota; Inflammation

Outcome Measures

Primary Outcomes (4)

• 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)

  Baseline (0 day) and 67 days

Secondary Outcomes (2)

• Effect of cannabidiol on oral microbiota

  Baseline (0 day) and 67 days

• Cannabidiol oral cavity side effects and gingival immune system

  Baseline (0 day) and 37 days

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

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

Combination Product: placebo dental gel, placebo toothpaste

CBD group

EXPERIMENTAL

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

Combination Product: Cannabidiol dental gel, Cannabidiol toothpaste

Corsodyl group

ACTIVE COMPARATOR

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

Combination Product: Placebo toothpaste, Corsodyl dental gel

Interventions

placebo dental gel, placebo toothpaste COMBINATION_PRODUCT

* Placebo dental gel applied by dentist after oral hygiene; without cannabidiol. * Placebo toothpaste; without cannabidiol. For daily use by patient.

Placebo group

Cannabidiol dental gel, Cannabidiol toothpaste COMBINATION_PRODUCT

* 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.

CBD group

Placebo toothpaste, Corsodyl dental gel COMBINATION_PRODUCT

* Corsodyl dental gel; containing 1 % (w/w) chlorhexidini digluconatis applied by dentist after oral hygiene. * Placebo toothpaste; without cannabidiol. For daily use by patient.

Corsodyl group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Palacky University: lead
• CB21 Pharma Ltd.: collaborator

Study Sites (1)

Department of Dentistry, Olomouc University Hospital

Olomouc, Czech Republic, CZ- 77900, Czechia

Location

Related Publications (8)

• 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.

  PMID: 32038896 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.

  PMID: 33526124 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.

  PMID: 34562980 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.

  PMID: 13332137 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.

  PMID: 5237684 BACKGROUND

• Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

  PMID: 1058834 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.

  PMID: 3485495 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.

  PMID: 35332345 BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis; Inflammation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Dentistry, Olomouc University Hospital

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: August 11, 2022
• Study Start: November 5, 2020
• Primary Completion: January 27, 2022
• Study Completion: February 1, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)