AzTrials
AzTrials

Chronic PeriodontitisPhase 1/2Stoma-CBDNCT05498012

CBD Effects on Periodontal Health of Patients With Chronic Periodontitis

A Phase 1/2 study testing Cannabidiol dental gel, Cannabidiol toothpaste in people with Chronic Periodontitis, run by Palacky University at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 35 to 65 years
Conditions the study is for
Chronic Periodontitis
What is being tested?
Cannabidiol dental gel, Cannabidiol toothpaste
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteCzechia
Study dates
5 Nov 2020to 1 Feb 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Czechia1 site

  • Department of Dentistry, Olomouc University Hospital

    Olomouc, Czech Republic, CZ- 77900

Other trials in Czechia

About this study

Official title: Cannabidiol Effects on Chronic Periodontitis: Monocentric, Randomized, Interventional and Placebo-controlled Study

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

Read the 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.

Being tested
placebo dental gel, placebo toothpaste, Cannabidiol dental gel, Cannabidiol toothpaste, Placebo toothpaste, Corsodyl dental gel
Keywords
Periodontitis, Phytocannabinoid, Cannabidiol, Dental gel, Oral microbiota, Inflammation
Medical subject headings
Chronic Periodontitis, Periodontitis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placebo dental gel, placebo toothpasteCombination product

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

  • Cannabidiol dental gel, Cannabidiol toothpasteCombination 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.

  • Placebo toothpaste, Corsodyl dental gelCombination 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.
Study groups in NCT05498012
Study groupRoleWhat they receive
Placebo groupPlacebo comparatorDental gel applied by dentist after oral hygiene (no cannabidiol). Toothpaste for daily use as needed for patients (no cannabidiol).
Receives: Combination Product: placebo dental gel, placebo toothpaste
CBD groupExperimentalDental CBD (cannabidiol) gel applied by dentist after oral hygiene. CBD toothpaste for daily use as needed for patients.
Receives: Combination Product: Cannabidiol dental gel, Cannabidiol toothpaste
Corsodyl groupActive comparatorCorsodyl dental gel applied by dentist after oral hygiene. Toothpaste for daily use as needed for patients (no cannabidiol).
Receives: Combination Product: Placebo toothpaste, Corsodyl dental gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline (0 day) and 67 days

  2. 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)

    Measured: Baseline (0 day) and 67 days

  3. 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)

    Measured: Baseline (0 day) and 67 days

  4. 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)

    Measured: Baseline (0 day) and 67 days

Secondary outcomes (2)

  1. 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)

    Measured: Baseline (0 day) and 67 days

  2. 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)

    Measured: Baseline (0 day) and 37 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2022
  2. Study start5 Nov 2020
  3. Primary completion27 Jan 2022
  4. Study completion1 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05498012
Sponsor's protocol ID
#3620
Acronym
Stoma-CBD
Status last verified
Aug 2022
First submitted
16 Mar 2022
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32038896

  • 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.

    PubMed 33526124

  • 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.

    PubMed 34562980

  • 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.

    PubMed 13332137

  • 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.

    PubMed 5237684

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

    PubMed 1058834

  • 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.

    PubMed 3485495

  • 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.

    PubMed 35332345

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cannabidiol dental gel, Cannabidiol toothpaste in people with Chronic Periodontitis, run by Palacky University at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of cannabidiol on periodontal health (Russell's periodontal index ) of patients with chronic periodontitis (time frame: Baseline (0 day) and 67 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05498012, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in