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.
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.
- Conditions
- Periodontal Diseases
- 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 group | Role | What they receive |
|---|---|---|
| Thyme honey | Experimental | 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 (Ibrahim et al., 2021). Receives: Other: Thyme honey |
| Saline | Placebo comparator | The 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.
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)
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.
- First posted11 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion20 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Ghalwash, British University In Egypt
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Locally Delivered Thyme Honey as a Novel Adjunct to Non-surgical Periodontal Therapy: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06201975
- Acronym / sponsor ID
- 23-062
- Conditions
- Periodontal Diseases
- Keywords
- Periodontitis, Thyme honey, anti-inflammatory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 20 Feb 2024 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Thyme honey | Experimental | Other: Thyme honeyThe 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). |
| Saline | Placebo comparator | Other: Thyme honeyThe control group will receive scaling and root debridement with normal saline irrigation on sites with PPD ≥ 5 mm. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - Both genders, aged above 18 years.
- All patients must have a periodontal disease.
- Patients must be able to make reliable decision or communications.
Key exclusion criteria (2 listed)
- - Smoking, Alcohol.
- Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thyme honeyThyme 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 | Other | Saline, Thyme honey |
Primary outcome
Clinical attachment loss (CAL)
Time frame: 6 weeks
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).
1 secondary outcome
Bleeding on probing
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.