AzTrials
AzTrials

Periodontal DiseasesNCT06201975

Efficacy of Thyme Honey as a Novel Adjunct to Non-surgical Periodontal Therapy

A study testing Thyme honey in people with Periodontal Diseases, run by British University In Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Periodontal diseases are disease processes involving the periodontium, a term used to describe the supportive apparatus surrounding the tooth, which includes the gingival tissue, alveolar bone, cementum, and periodontal ligament. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Periodontal Diseases
What is being tested?
Thyme honey
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
No sites listed yet
Study dates
1 Jan 2024to 20 Feb 2024
Phase
Interventional
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - Both genders, aged above 18 years.
  • All patients must have a periodontal disease.
  • Patients must be able to make reliable decision or communications.

Who cannot join

  • - Smoking, Alcohol.
  • Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.

About this study

Official title: Efficacy of Locally Delivered Thyme Honey as a Novel Adjunct to Non-surgical Periodontal Therapy: A Randomized Controlled Clinical Trial

Periodontal diseases are disease processes involving the periodontium, a term used to describe the supportive apparatus surrounding the tooth, which includes the gingival tissue, alveolar bone, cementum, and periodontal ligament. Thyme honey, as a conventional therapy, might be a novel antioxidant to abate many of the diseases directly or indirectly associated with oxidative stress. To the best of the researchers' knowledge, there are no published studies on the management of periodontitis in using locally delivered Thyme honey.

Read the detailed description

In 2017, the American Academy of Periodontology, in collaboration with the European Federation of Periodontology, devised a new classification of periodontal and peri-implant diseases. In this new classification, periodontitis can be subdivided into three categories, Necrotizing periodontal diseases, Periodontitis, Periodontitis as a manifestation of systemic diseases.

Non-surgical treatment is valuable in mild to moderate periodontitis whereas surgical treatment is useful in progressive cases. Confined drug delivery systems-mouth rinses, irrigating solutions and sustained release devices are used for distribution of antimicrobial agents.

It has been observed that artificial antimicrobial agents and antibiotics are identified to cause antimicrobial resistance. It has also been observed that appearance of formerly rare infections is on the rise perhaps due to the incorrect or prevalent overuse of antimicrobials. Natural phytochemicals have demonstrated to be worthy substitutes to synthetic agents.

It is interesting fact to note that two of the most populated countries in the world China and India, have used herbal medicine for the managing of oral infections, comprising periodontal disease as well for more than a duration of 2000 years.

It has been found that in adults with chronic periodontitis, scaling and root planning along with use of an adjunctive antimicrobial mediator increases patient outcomes over a period of time compared to scaling alone. Modern chemotherapeutic agents display significant efficacy in improving periodontal health but owing to undesirable side effects such as tooth discoloration, taste alteration, and price of these substances, the usage of herbal products has increased lately and could be especially of high benefit to lower socioeconomic populations around the world.

Herbal medicines and preparations comprise of plant constituents professed to have therapeutic benefits. Herbal products are favored over conventional drugs owing to extensive natural activity, advanced safety margin, and inferior costs. Additionally, the modern drugs are known to cause several side effects. Continuous intake of modern drugs has sometimes caused in antibiotic resistance thereby herbal medicines are being used gradually as dietary add-ons to combat or avert common ailments affecting human body and oral cavity.

Honey as a natural product has clinched the attention of researchers as a complementary and alternative medicine. Honey as a folk medicine is referred in the utmost ancient written archives.

Demarcation of its uses in current professional medicine as a potential therapy is entirely underutilized. However, there is an affinity for some researchers to fire out a coherent proposition that usage of honey as a natural product supplement is well intentioned for reflection as a therapy or adjuvant antioxidant therapy in current medicine. The composition of honey varies from floral source to origin.

Thyme honey has been studied against various ailments in animal and human models. Published research denotes it as a novel antioxidant agent. It exhibits a broad spectrum therapeutic properties such as anti-inflammatory, antibacterial, antimutagenic, expedite wound healings, antidiabetic, antiviral, antifungal, and antitumor effects.

Additionally, the anti-inflammatory properties of Greek thymus vulgaris extract was examined in recent research which reported its ability to reduce the LPS-induced elevation in cyclooxygenase (COX)-2, nuclear factor-kappa B (NF-кB), TNF-α, and produced a more potent attenuating effect than dexamethasone for most of the studied inflammatory mediators.

Moreover, thymol was reported to possess an inhibitory effect on TNF-α, IL-6, IFN-γ, IL-1β and IL-17, C-reactive protein and myeloperoxidase. Furthermore, unfractionated essential oil from T. vulgaris was found to reduce neutrophil infiltration during inflammatory response.Thyme honey, as a conventional therapy, might be a novel antioxidant to abate many of the diseases directly or indirectly associated with oxidative stress. To the best of the researchers' knowledge, there are no published studies on the management of periodontitis in using locally delivered Thyme honey.

Being tested
Thyme honey
Keywords
Periodontitis, Thyme honey, anti-inflammatory
Medical subject headings
Periodontal Diseases, Periodontitis

What participants receive

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

  • Thyme honeyOther

    Thyme honey will be delivered to the sites until overflows using a syringe with plastic catheter of cannula 20 g (B Braun) attached to it. Patients will be reviewed at 6 weeks to re-evaluate the clinical periodontal parameters

Study groups in NCT06201975
Study groupRoleWhat they receive
Thyme honeyExperimentalThe experimental group will receive scaling and root debridement and locally delivered 0.5 ml non-diluted Thyme honey on sites with PPD ≥ 5 mm. Thyme honey will be delivered to the sites until overflows using a syringe with plastic catheter of cannula 20 g (B Braun) attached to it. Patients will be reviewed at 6 weeks to re-evaluate the clinical periodontal parameters (Ibrahim et al., 2021).
Receives: Other: Thyme honey
SalinePlacebo comparatorThe control group will receive scaling and root debridement with normal saline irrigation on sites with PPD ≥ 5 mm.
Receives: Other: Thyme honey

What is being measured

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

  1. Clinical attachment loss (CAL)

    With a periodontal probe, PD and CAL will be measured on six locations of the teeth (mesio-buccal/facial, mid-buccal/facial, disto-buccal/facial, mesio-lingual/palatinal, mid-lingual/palatinal, disto-lingual/palatinal).

    Measured: 6 weeks

Secondary outcomes (1)
  1. Bleeding on probing

    The proportion of bleeding sites 10 second after being stimulated by a standardized manual probe with a controlled force to the bottom of the sulcus/pocket at six locations (mesio-buccal, buccal, disto-buccal, mesio-lingual, lingual, disto-lingual) on all present teeth will be assessed dichotomously as a BOP score on all present teeth

    Measured: 6 weeks

Timeline

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

  1. First posted11 Jan 2024
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion20 Feb 2024 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The experimental group will receive scaling and root debridement and locally delivered 0.5 ml non-diluted Thyme honey on sites with PPD ≥ 5 mm. Thyme honey will be delivered to the sites until overflows using a syringe with plastic catheter of cannula 20 g (B Braun) attached to it. Patients will be reviewed at 6 weeks to re-evaluate the clinical periodontal parameters. The control group will receive scaling and root debridement with normal saline irrigation on sites with PPD ≥ 5 mm.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06201975
Sponsor's protocol ID
23-062
Status last verified
Jan 2024
First submitted
2 Jan 2024
Last updated
11 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Thyme honey in people with Periodontal Diseases, run by British University In Egypt.

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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Results are not available in the source record.

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?

Clinical attachment loss (CAL) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 Jan 2024.

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