Periodontal DiseasesNCT06129097
Thyme Honey Mouthwash in Management of Periodontitis in Renal Patients
A study testing Thyme honey mouthwash in people with Periodontal Diseases and Periodontal Pocket, run by British University In Egypt at 1 site in Egypt.
Trial summary
There is a known correlation between oral health and systemic disease. Particularly significant evidences associate periodontal bacteria and tooth loss to systemic disorders and specifically to cardiovascular disease, such as high BP. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Periodontal Diseases, Periodontal Pocket, Periodontal Attachment Loss
- What is being tested?
- Thyme honey mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Mar 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 be clinically diagnosed of ESRD undergoing hemodialysis.
- All patients must have a periodontal disease.
- Patients must be able to make reliable decision or communications.
Who cannot join
- - Smoking, Alcohol.
- Patient with history of any serious illness as malignancy, who undergo kidney transplant.
- Patients with any autoimmune disease.
- Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
- Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thyme Honey Mouthwash in Management of Periodontitis in Renal Patients on Hemodialysis: A Randomized Controlled Clinical Trial.
There is a known correlation between oral health and systemic disease. Particularly significant evidences associate periodontal bacteria and tooth loss to systemic disorders and specifically to cardiovascular disease, such as high BP. Furthermore, a correlation between periodontal disease and hypertension has been recently reported ESRD and the medications used by those patients create complications in a variety of systems and organs, which frequently worsens or causes new pathologies in the oral cavity, such as caries, periodontal disease, and different mucosal lesions.
Therefore, the current trial was set up to first evaluate the effect of thyme honey oral rinse in ESRD patients with periodontitis using CAL as a primary objective, and to evaluate the clinical effectiveness of thyme honey oral rinse in ESRD patients with periodontitis on bleeding on probing (BOP) and plaque index, and salivary NO levels as secondary objectives.
Read the detailed description
Periodontal diseases can be seen in up to 90% of the global population, making it the most common oral disease. In the United States alone, cross-sectional studies show that approximately 50% of adults currently have some form of gingivitis, and up to 80% have experienced some form of periodontal disease in their life. Certain groups have been shown to have an increased incidence of periodontal diseases.
There is a known correlation between oral health and systemic disease . Particularly significant evidences associate periodontal bacteria and tooth loss to systemic disorders and specifically to cardiovascular disease, such as high BP. Furthermore, a correlation between periodontal disease and hypertension has been recently reported.
ESRD and the medications used by those patients create complications in a variety of systems and organs, which frequently worsens or causes new pathologies in the oral cavity, such as caries, periodontal disease, and different mucosal lesions.
The emergence of a chronic systemic inflammatory disease in people with ESRD is a common occurrence. The reasons of this inflammation are most likely multifaceted and complex. A number of illnesses and comorbidities have been identified as potential influencers of an increase in the inflammatory state.
The accelerated periodontal disease with pocket formation, gingival recession, and bone and tooth loss is due not only to inadequate oral hygiene and inflammatory disease burden but also to renal osteodystrophy, high urea concentration, salivary changes in composition and the host factors related to the underlying systemic disease that modify the host response to periodontal infection.
Through nitrate-nitrite reduction, some commensal oral bacteria can supply bioactive NO, essential for the endothelial cell function and regulation of arterial BP.
NO is a free radical and simple gas that is synthesized endogenously by a family of enzymes namely NOSs. Normally, NO is produced from the amino acid L-arginine in the presence of oxygen by eNOS and it has an important role in preserving vascular homeostasis. NO is a multifunctional signaling molecule involved in the maintenance of metabolic and cardiovascular homeostasis and also a potent endogenous vasodilator that suppresses the formation of vascular lesions in atherosclerosis. Imbalance in NO bioavailability is associated with some cardiovascular and metabolic diseases.
Reduction of oxygen provision, such as in the case of myocardial ischaemia, compromises NO synthesis.
Decreased production or activity of NO, due to endothelial dysfunction, is responsible for the pathogenesis of many cardiovascular diseases, including atherosclerosis and CVD such as hypertension, coronary artery disease.
The prospective to restore the oral microbiome by probiotics to increase NO bioavailability represents a new strategy in cardiovascular medicine and dentistry. Therefore, providing NO generation by using nitrite and nitrate may be considered a potential therapeutic approach to the management of resistant hypertensive patients.
The anti-inflammatory properties of thyme extracts due to that thyme exerted a dose-dependent decrease in the production and gene expression of the proinflammatory mediators' tumor necrosis factor (TNF)-α, IL-1B, and IL-6 associated with an increase in the anti-inflammatory IL-10 cytokine secretion in activated macrophages, suggesting beneficial application of thyme honey as an oral health aid.
Thyme honey is an Iranian domestic honey produced from the nectar of different species of thyme plants. Its components are different from thyme extract in quantities. The major constituents of thyme extract are phenolic compounds (such as thymol). However, thyme honey may contain some of these essential oil components at a lower concentration Therefore, the current trial was set up to first evaluate the effect of thyme honey oral rinse in ESRD patients with periodontitis using CAL as a primary objective, and to evaluate the clinical effectiveness of thyme honey oral rinse in ESRD patients with periodontitis on bleeding on probing (BOP) and plaque index, and salivary NO levels as secondary objectives.
- Conditions
- Periodontal Diseases, Periodontal Pocket, Periodontal Attachment Loss, Periodontal Inflammation
- Being tested
- Thyme honey mouthwash
- Keywords
- Thyme honey, Nitric oxide, Hemodialysis, Periodontitis
- Medical subject headings
- Periodontal Diseases, Periodontal Pocket, Periodontal Attachment Loss, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyme honey mouthwashOther
- Thyme honey will be applied as oral rinse.
- Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day.
- Patients will be instructed to perform thyme honey rinses in the oral mucosa.
- Patients will be instructed not to swallow the thyme honey oral rinse.
| Study group | Role | What they receive |
|---|---|---|
| Thyme honey mouthwash | Experimental | * Thyme honey will be applied as oral rinse.
* Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day.
* Patients will be instructed to perform thyme honey rinses in the oral mucosa.
* Patients will be instructed not to swallow the thyme honey oral rinse. Receives: Other: Thyme honey mouthwash |
| Saline mouthwash | Placebo comparator | Patients in the control arm followed the same protocol with normal saline rinses. Receives: Other: Thyme honey mouthwash |
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 (3)
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
Plaque index
presence of plaque is scored on a dichotomous variable and the final score per individual is the sum of the plaque scores divided by the number of surfaces examined.
Measured: 6 weeks
Salivary Nitric oxide levels
- Patients will also be asked to wash their mouths before collecting the samples. Then they will ask to collect the saliva using spitting method in a sterile tube every 1 min for 5 min.
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 posted13 Nov 2023
- Study start1 Jan 2024
- Primary completion1 Feb 2024
- Study completion1 Mar 2024
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
- Treatment protocol (for the intervention group): * Thyme honey will be applied as oral rinse. * Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day. * Patients will be instructed to perform thyme honey rinses in the oral mucosa. * Patients will be instructed not to swallow the thyme honey oral rinse. The control group (placebo): Patients in the control arm followed the same protocol with normal saline rinses. All patients will receive a course of motivation, oral hygiene instructions (emphasizing proper tooth brushing technique, flossing, interdental brush, and mouthwash usage), scaling, polishing and root debridement with an ultrasonic scaler and Gracey curettes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa bakr, British University In Egypt
- Investigators
- Dalia Ghalwash, Phd, Study director, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129097
- Sponsor's protocol ID
- 23-063
- Status last verified
- Aug 2024
- First submitted
- 8 Nov 2023
- Last updated
- 6 Aug 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyme Honey Mouthwash in Management of Periodontitis in Renal Patients on Hemodialysis: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT06129097
- Acronym / sponsor ID
- 23-063
- Conditions
- Periodontal Diseases, Periodontal Pocket, Periodontal Attachment Loss, Periodontal Inflammation
- Keywords
- Thyme honey, Nitric oxide, Hemodialysis, Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 13 Nov 2023 (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.
There is a known correlation between oral health and systemic disease. Particularly significant evidences associate periodontal bacteria and tooth loss to systemic disorders and specifically to cardiovascular disease, such as high BP. Furthermore, a correlation between periodontal disease and hypertension has been recently reported ESRD and the medications used by those patients create complications in a variety of systems and organs, which frequently worsens or causes new pathologies in the oral cavity, such as caries, periodontal disease, and different mucosal lesions.
Therefore, the current trial was set up to first evaluate the effect of thyme honey oral rinse in ESRD patients with periodontitis using CAL as a primary objective, and to evaluate the clinical effectiveness of thyme honey oral rinse in ESRD patients with periodontitis on bleeding on probing (BOP) and plaque index, and salivary NO levels as secondary objectives.
Detailed description
Periodontal diseases can be seen in up to 90% of the global population, making it the most common oral disease. In the United States alone, cross-sectional studies show that approximately 50% of adults currently have some form of gingivitis, and up to 80% have experienced some form of periodontal disease in their life. Certain groups have been shown to have an increased incidence of periodontal diseases.
There is a known correlation between oral health and systemic disease . Particularly significant evidences associate periodontal bacteria and tooth loss to systemic disorders and specifically to cardiovascular disease, such as high BP. Furthermore, a correlation between periodontal disease and hypertension has been recently reported.
ESRD and the medications used by those patients create complications in a variety of systems and organs, which frequently worsens or causes new pathologies in the oral cavity, such as caries, periodontal disease, and different mucosal lesions.
The emergence of a chronic systemic inflammatory disease in people with ESRD is a common occurrence. The reasons of this inflammation are most likely multifaceted and complex. A number of illnesses and comorbidities have been identified as potential influencers of an increase in the inflammatory state.
The accelerated periodontal disease with pocket formation, gingival recession, and bone and tooth loss is due not only to inadequate oral hygiene and inflammatory disease burden but also to renal osteodystrophy, high urea concentration, salivary changes in composition and the host factors related to the underlying systemic disease that modify the host response to periodontal infection.
Through nitrate-nitrite reduction, some commensal oral bacteria can supply bioactive NO, essential for the endothelial cell function and regulation of arterial BP.
NO is a free radical and simple gas that is synthesized endogenously by a family of enzymes namely NOSs. Normally, NO is produced from the amino acid L-arginine in the presence of oxygen by eNOS and it has an important role in preserving vascular homeostasis. NO is a multifunctional signaling molecule involved in the maintenance of metabolic and cardiovascular homeostasis and also a potent endogenous vasodilator that suppresses the formation of vascular lesions in atherosclerosis. Imbalance in NO bioavailability is associated with some cardiovascular and metabolic diseases.
Reduction of oxygen provision, such as in the case of myocardial ischaemia, compromises NO synthesis.
Decreased production or activity of NO, due to endothelial dysfunction, is responsible for the pathogenesis of many cardiovascular diseases, including atherosclerosis and CVD such as hypertension, coronary artery disease.
The prospective to restore the oral microbiome by probiotics to increase NO bioavailability represents a new strategy in cardiovascular medicine and dentistry. Therefore, providing NO generation by using nitrite and nitrate may be considered a potential therapeutic approach to the management of resistant hypertensive patients.
The anti-inflammatory properties of thyme extracts due to that thyme exerted a dose-dependent decrease in the production and gene expression of the proinflammatory mediators' tumor necrosis factor (TNF)-α, IL-1B, and IL-6 associated with an increase in the anti-inflammatory IL-10 cytokine secretion in activated macrophages, suggesting beneficial application of thyme honey as an oral health aid.
Thyme honey is an Iranian domestic honey produced from the nectar of different species of thyme plants. Its components are different from thyme extract in quantities. The major constituents of thyme extract are phenolic compounds (such as thymol). However, thyme honey may contain some of these essential oil components at a lower concentration Therefore, the current trial was set up to first evaluate the effect of thyme honey oral rinse in ESRD patients with periodontitis using CAL as a primary objective, and to evaluate the clinical effectiveness of thyme honey oral rinse in ESRD patients with periodontitis on bleeding on probing (BOP) and plaque index, and salivary NO levels as secondary objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment protocol (for the intervention group): * Thyme honey will be applied as oral rinse. * Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day. * Patients will be instructed to perform thyme honey rinses in the oral mucosa. * Patients will be instructed not to swallow the thyme honey oral rinse. The control group (placebo): Patients in the control arm followed the same protocol with normal saline rinses. All patients will receive a course of motivation, oral hygiene instructions (emphasizing proper tooth brushing technique, flossing, interdental brush, and mouthwash usage), scaling, polishing and root debridement with an ultrasonic scaler and Gracey curettes.
| Arm | Type | Receives |
|---|---|---|
| Thyme honey mouthwash | Experimental | Other: Thyme honey mouthwash* Thyme honey will be applied as oral rinse. * Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day. * Patients will be instructed to perform thyme honey rinses in the oral mucosa. * Patients will be instructed not to swallow the thyme honey oral rinse. |
| Saline mouthwash | Placebo comparator | Other: Thyme honey mouthwashPatients in the control arm followed the same protocol with normal saline rinses. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Both genders, aged above 18 years.
- All patients must be clinically diagnosed of ESRD undergoing hemodialysis.
- All patients must have a periodontal disease.
- Patients must be able to make reliable decision or communications.
Key exclusion criteria (5 listed)
- - Smoking, Alcohol.
- Patient with history of any serious illness as malignancy, who undergo kidney transplant.
- Patients with any autoimmune disease.
- Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.
- Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.
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 honey mouthwash* Thyme honey will be applied as oral rinse. * Based on this protocol, patients will have oral rinses (20 ml of thyme honey diluted in 100 ml of purified water) 3 times per day. * Patients will be instructed to perform thyme honey rinses in the oral mucosa. * Patients will be instructed not to swallow the thyme honey oral rinse. | Other | Saline mouthwash, Thyme honey mouthwash |
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).
3 secondary outcomes
Bleeding on probing
Time frame: 6 weeks
Plaque index
Time frame: 6 weeks
Salivary Nitric oxide levels
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 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.
Dalia Ghalwash, Phd study director
British University In Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thyme honey mouthwash in people with Periodontal Diseases and Periodontal Pocket, run by British University In Egypt at 1 site 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 4 inclusion and 5 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 6 Aug 2024. 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 Egypt. 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.
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?
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 6 Aug 2024.