Periodontal DiseasesNCT06235021
Clinical Efficacy of Saffron Mouth Rinse in Periodontitis Patients With Renal Disease
A study testing Saffron and chlorhexidine mouthwash in people with Periodontal Diseases and Periodontal Pocket, run by British University In Egypt at 1 site in Egypt.
Trial summary
The commensal oral bacteria are responsible for the initiation and propagation of the disease through the process of dysbiosis, or microbial imbalance. The disease proceeds cyclically with periods of activity and quiescence until therapeutic action is taken, or the tooth and surrounding structures are destroyed by the… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Periodontal Diseases, Periodontal Pocket, Periodontal Inflammation
- What is being tested?
- Saffron and chlorhexidine mouthwash
- 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 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.
- 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.
Egypt1 site, 1 recruiting
- Recruiting
The British University in Egypt
Cairo, 3753450
Dalia M Ghalwash, 01005120159, dalia.ghalwash@bue.edu.eg
About this study
Official title: Clinical Efficacy of Saffron Mouth Rinse in Periodontitis Patients With Renal Disease: A Randomized Controlled Clinical Trial
The commensal oral bacteria are responsible for the initiation and propagation of the disease through the process of dysbiosis, or microbial imbalance. The disease proceeds cyclically with periods of activity and quiescence until therapeutic action is taken, or the tooth and surrounding structures are destroyed by the disease process that may result in the loss of the tooth. As periodontal disease progresses from gingivitis to periodontitis, a greater number of anaerobic organisms colonize deeper periodontal pockets, such as Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis, which triggers the host inflammatory response. This response includes the production and dissemination of C-reactive protein (CRP), a biomarker of inflammation, as well as various neutrophil and macrophage compounds such as tumor necrosis factor-alpha (TNF-a), matrix metalloproteinases (MMPs), and interleukins (IL-1 and IL-8). An elevated serum CRP level suggests that the inflammation arising as a result of periodontitis may correlate with cardiovascular pathology. Additionally, smoking creates an increasingly favorable environment for the growth of periodontal pathogens, thus furthering the disease process.
In recent meta-analysis, published articles on the effect of saffron supplementation on three inflammatory biomarkers (CRP, TNF-α, and IL-6) were evaluated. Combining eight eligible trials, it was demonstrated that saffron supplementation did not have a significant effect on serum levels of the three inflammatory biomarkers. However, in the subgroup analysis, saffron was found to significantly reduce CRP and TNF-α serum concentrations
Read the detailed description
Periodontitis, a common inflammatory dis ease, affects the teeth-supporting tissues. In this complex disease, dental biofilm interacts with inflammatory immune system, which may lead to an imbalance between bacterial invasion and the intensity of the host immune response. Scaling and root planning (SRP) is a common major meth od used as the gold standard for periodontal treatment. However, SRP alone has limited effects on some bacterial species and does not remove subgingival bacteria completely. This may be related to the fact that some species may exist in soft tissue, dentinal tubules, or root surface irregularities, which are associated with the treatment failure.
Therefore, to help the healing process, both chemical and herbal therapeutic mouthwashes were added to the treatment. In this way, herbs such as turmeric with its potent anti-inflammatory active ingredient, curcumin, or ginger have been used as adjunctive treatment for periodontitis along with SRP. In traditional Persian medicine, saffron and its extracts are used to improve digestion, increase appetite, relaxation, and treat liver diseases, spasm, toothache, rhinitis, pharyngitis, insomnia, depression, cough, asthma, bronchitis, fever, nausea, scarlet fever, urinary tract infections, cardiovascular disorders, and even cancers and immune system modulation. According to the modern studies, saffron has antioxidant, anti-inflammatory, anticoagulant, antibacterial and analgesic effects.
In recent years, herbal plants have received increasing attention considering their roles in health and disease. Saffron (Crocus sativus, L.) is an example of herbs, commonly used as a flavoring agent in food preparation. Saffron contains high amounts of carotenoid pigments (crocin, crocetin, α-carotene, lycopene, and zeaxanthin), monoterpene aldehydes (picrocrocin and safranal), monoterpenoids (crocusatines), isophorones, and flavonoids, which could contribute to its wide range of biological properties. A number of investigations have shown that saffron possesses anti-oxidant, anti-tumor, anti-genotoxic, and hypotensive properties. In addition, a growing number of studies have suggested that saffron possesses anti-inflammatory properties too.
However, clinical studies are very limited about the use of saffron in the field of oral diseases. A laboratory study reported that ethyl acetate extract of saffron has strong antimicrobial effects against various microorganisms such as both gram-positive (g+) and gram-negative (g-) bacteria, but it is obvious that alcoholic compounds themselves may have an antibacterial effect, so to avoid errors, the investigators chose the aqueous type from two types of alcoholic and aqueous extracts.
Considering the anti-inflammatory effect of saffron and due to the dissatisfaction of some patients with the taste of conventional mouthwashes, especially the gold standard chlorhexidine, this study was conducted to investigate the effect of mouthwash containing saffron aqueous extract on periodontal indices of patients with moderate to severe generalized periodontitis.
- Being tested
- Saffron, chlorhexidine mouthwash
- Keywords
- Saffron, Renal, Periodontitis
- Medical subject headings
- Periodontal Diseases, Periodontal Pocket, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaffronOther
Saffron powder (purchased from Moayeri Copmany2 in Oman, prepared from the stigma of Crocus sativus L.).
Total of 10 mg of saffron powder will be added to 100 ml of distilled water. Then, it will be incubated on a shaker for 24 h. The material will be passed through several layers of muslin cloth. The extracts will then be poured into a round bottom balloon and placed in the freezer at a temperature of -80°C. After freezing, the extracts were placed in a freeze-dryer.
In vacuum, the solvent will be removed and saffron powder will be obtained. After preparing the initial concentration, serial dilution with ratios of one-half and one-third will be performed in sterile vials and one-half of the final concentration will be discarded.
After the preparation of extract, the 0.2% saffron mouthwash will be prepared by mixing the following ingredients: 1. propylene glycol (5 g) 2. saffron extract (0.2 g) 3. polysorbate 80 (1.8 g) 4. sodium benzoate (0.2 g) 5. water (91 g).
chlorhexidine mouthwashOther
commercial product of 0.2% chlorhexidine mouthwash.
| Study group | Role | What they receive |
|---|---|---|
| Saffron | Experimental | The experimental group will receive scaling and root debridement and will be instructed to use a mouthwash containing aqueous extract of saffron twice a day for 6 weeks. Receives: Other: Saffron |
| chlorhexidine mouthwash. | Placebo comparator | The control group will receive scaling and root debridement and gargle their mouth with commercial product of 0.2% chlorhexidine mouthwash. Receives: Other: chlorhexidine 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, pocket depth (PD) and clinical attachment loss (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
An index for the entire mouth is determined by dividing the total score by the number of surfaces examined.Quigley-Hain plaque index0No plaque1Isolated flecks of plaque at the gingival margin2A continuous band of plaque up to 1mm at the gingival margin3Plaque greater than 1mm in width and covering up to one third of the tooth surface4Plaque covering from one thirds to two thirds of the tooth surface5Plaque covering more than two thirds of the tooth surface higher scores indicate worse outcome and lower scores indicate better outcome
Measured: 6 weeks
Gingival crevicular fluid (C- reactive protein)
The gingival crevicular fluid (GCF) will collected from PPD ≥ 5 mm in control and interventional sides for each patient from two buccal sites of two different teeth GCF will be collected by using Periopaper (Oraflow Inc) strip before scaling at baseline and after 6 weeks at the same sites during the review visit.
The collection method will adapted. Samples will be collected in the morning, between 9 am to 12.30 pm. Prior to GCF collection, supragingival plaque and calculus will be carefully removed by using a hand scaler.
higher scores indicate worse outcome and lower scores indicate better outcome
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 posted31 Jan 2024
- Study start1 Jan 2024
- Primary completion12 Jan 2024
- Study completion1 Mar 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 will be instructed to use a mouthwash containing aqueous extract of saffron twice a day for 6 weeks.
- 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
- Investigators
- Dalia Ghalwash, Study director, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235021
- Sponsor's protocol ID
- 23-064
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 31 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Saffron Mouth Rinse in Periodontitis Patients With Renal Disease: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06235021
- Acronym / sponsor ID
- 23-064
- Keywords
- Saffron, Renal, Periodontitis
- 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 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 31 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.
The commensal oral bacteria are responsible for the initiation and propagation of the disease through the process of dysbiosis, or microbial imbalance. The disease proceeds cyclically with periods of activity and quiescence until therapeutic action is taken, or the tooth and surrounding structures are destroyed by the disease process that may result in the loss of the tooth. As periodontal disease progresses from gingivitis to periodontitis, a greater number of anaerobic organisms colonize deeper periodontal pockets, such as Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis, which triggers the host inflammatory response. This response includes the production and dissemination of C-reactive protein (CRP), a biomarker of inflammation, as well as various neutrophil and macrophage compounds such as tumor necrosis factor-alpha (TNF-a), matrix metalloproteinases (MMPs), and interleukins (IL-1 and IL-8). An elevated serum CRP level suggests that the inflammation arising as a result of periodontitis may correlate with cardiovascular pathology. Additionally, smoking creates an increasingly favorable environment for the growth of periodontal pathogens, thus furthering the disease process.
In recent meta-analysis, published articles on the effect of saffron supplementation on three inflammatory biomarkers (CRP, TNF-α, and IL-6) were evaluated. Combining eight eligible trials, it was demonstrated that saffron supplementation did not have a significant effect on serum levels of the three inflammatory biomarkers. However, in the subgroup analysis, saffron was found to significantly reduce CRP and TNF-α serum concentrations
Detailed description
Periodontitis, a common inflammatory dis ease, affects the teeth-supporting tissues. In this complex disease, dental biofilm interacts with inflammatory immune system, which may lead to an imbalance between bacterial invasion and the intensity of the host immune response. Scaling and root planning (SRP) is a common major meth od used as the gold standard for periodontal treatment. However, SRP alone has limited effects on some bacterial species and does not remove subgingival bacteria completely. This may be related to the fact that some species may exist in soft tissue, dentinal tubules, or root surface irregularities, which are associated with the treatment failure.
Therefore, to help the healing process, both chemical and herbal therapeutic mouthwashes were added to the treatment. In this way, herbs such as turmeric with its potent anti-inflammatory active ingredient, curcumin, or ginger have been used as adjunctive treatment for periodontitis along with SRP. In traditional Persian medicine, saffron and its extracts are used to improve digestion, increase appetite, relaxation, and treat liver diseases, spasm, toothache, rhinitis, pharyngitis, insomnia, depression, cough, asthma, bronchitis, fever, nausea, scarlet fever, urinary tract infections, cardiovascular disorders, and even cancers and immune system modulation. According to the modern studies, saffron has antioxidant, anti-inflammatory, anticoagulant, antibacterial and analgesic effects.
In recent years, herbal plants have received increasing attention considering their roles in health and disease. Saffron (Crocus sativus, L.) is an example of herbs, commonly used as a flavoring agent in food preparation. Saffron contains high amounts of carotenoid pigments (crocin, crocetin, α-carotene, lycopene, and zeaxanthin), monoterpene aldehydes (picrocrocin and safranal), monoterpenoids (crocusatines), isophorones, and flavonoids, which could contribute to its wide range of biological properties. A number of investigations have shown that saffron possesses anti-oxidant, anti-tumor, anti-genotoxic, and hypotensive properties. In addition, a growing number of studies have suggested that saffron possesses anti-inflammatory properties too.
However, clinical studies are very limited about the use of saffron in the field of oral diseases. A laboratory study reported that ethyl acetate extract of saffron has strong antimicrobial effects against various microorganisms such as both gram-positive (g+) and gram-negative (g-) bacteria, but it is obvious that alcoholic compounds themselves may have an antibacterial effect, so to avoid errors, the investigators chose the aqueous type from two types of alcoholic and aqueous extracts.
Considering the anti-inflammatory effect of saffron and due to the dissatisfaction of some patients with the taste of conventional mouthwashes, especially the gold standard chlorhexidine, this study was conducted to investigate the effect of mouthwash containing saffron aqueous extract on periodontal indices of patients with moderate to severe generalized periodontitis.
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 will be instructed to use a mouthwash containing aqueous extract of saffron twice a day for 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Saffron | Experimental | Other: SaffronThe experimental group will receive scaling and root debridement and will be instructed to use a mouthwash containing aqueous extract of saffron twice a day for 6 weeks. |
| chlorhexidine mouthwash. | Placebo comparator | Other: chlorhexidine mouthwashThe control group will receive scaling and root debridement and gargle their mouth with commercial product of 0.2% chlorhexidine mouthwash. |
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 (3 listed)
- - Smoking, Alcohol.
- 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 |
|---|---|---|
| SaffronSaffron powder (purchased from Moayeri Copmany2 in Oman, prepared from the stigma of Crocus sativus L.). Total of 10 mg of saffron powder will be added to 100 ml of distilled water. Then, it will be incubated on a shaker for 24 h. The material will be passed through several layers of muslin cloth. The extracts will then be poured into a round bottom balloon and placed in the freezer at a temperature of -80°C. After freezing, the extracts were placed in a freeze-dryer. In vacuum, the solvent will be removed and saffron powder will be obtained. After preparing the initial concentration, serial dilution with ratios of one-half and one-third will be performed in sterile vials and one-half of the final concentration will be discarded. After the preparation of extract, the 0.2% saffron mouthwash will be prepared by mixing the following ingredients: 1. propylene glycol (5 g) 2. saffron extract (0.2 g) 3. polysorbate 80 (1.8 g) 4. sodium benzoate (0.2 g) 5. water (91 g). | Other | Saffron |
| chlorhexidine mouthwashcommercial product of 0.2% chlorhexidine mouthwash. | Other | chlorhexidine mouthwash. |
Primary outcome
Clinical attachment loss (CAL)
Time frame: 6 weeks
With a periodontal probe, pocket depth (PD) and clinical attachment loss (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
Gingival crevicular fluid (C- reactive protein)
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 31 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.
Dalia Ghalwash 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 Saffron and chlorhexidine 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 3 inclusion and 3 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 31 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Ras, Phd (01098015060, asmaa.aboubakr@bue.edu.eg), or a site near the patient. 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 31 Jan 2024.