Inflammatory DiseasePhase 1NCT05546788
Hydroxylated Polymethoxy Flavones Solid Dispersion in Treatment of Periodontitis
A Phase 1 study testing scaling and root planing, hydroxylated poly methoxy flavones and chlorhexidine in people with Inflammatory Disease and Periodontal Diseases, run by Assiut University.
Trial summary
Periodontitis is a serious gum infection that damages the soft tissue and, without treatment, can destroy the bone that supports your teeth. Hydroxylated poly methoxy flavones are a combination of naturally occurring flavonoids extracted from the orange peel and exert anti-inflammatory, antibacterial, and antifungal… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Disease, Periodontal Diseases
- What is being tested?
- scaling and root planing, hydroxylated poly methoxy flavones and chlorhexidine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2023to 20 Nov 2023
- Phase
- Phase 1
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with periodontitis stage I-II
- free from any systemic disorders.
- no mobility - non-smokers - no parafunctional habits.
- Each patient with minimum three periodontitis sites ( split-mouth study)
Who cannot join
- Smokers.
- patients with diabetes, and hypertension.
About this study
Official title: The Effectiveness of Hydroxylated Polymethoxy Flavones Solid Dispersion Incorporated Sodium Carboxymethyl Cellulose Gel With Periodontal Debridement in the Treatment of Periodontitis. Clinical- Biochemical Study
Periodontitis is a serious gum infection that damages the soft tissue and, without treatment, can destroy the bone that supports your teeth.
Hydroxylated poly methoxy flavones are a combination of naturally occurring flavonoids extracted from the orange peel and exert anti-inflammatory, antibacterial, and antifungal activity however, this extract is poorly soluble and poorly absorbable. In this work, this extract was formulated as a solid dispersion formulation to enhance its biological activity and then incorporated into a gel base and used in the treatment of periodontitis after clinical debridement.
Read the detailed description
In the study, there are 3 groups; the first one first one received plain sodium carboxymethylcellulose. Group II received chlorhexidine gel. GroupIII received Hydroxylated poly methoxy flavones solid dispersion incorporated into sodium carboxymethylcellulose gel.
In all groups, there is clinical debridement before injection of gels.
- Conditions
- Inflammatory Disease, Periodontal Diseases
- Being tested
- scaling and root planing, hydroxylated poly methoxy flavones, chlorhexidine, placebo
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scaling and root planingProcedure or surgery
subgingival Depridement
hydroxylated poly methoxy flavonesDrug
Received hydroxylated poly methoxy flavones extract solid dispersion incorporated into sodium carboxymethylcellulose gel
chlorhexidineDrug
Received chlorhexidine gel
placeboDrug
Received placebo gel
| Study group | Role | What they receive |
|---|---|---|
| hydroxylated polymethyl flavones group | Active comparator | SRP then hydroxylated polymethyl flavones addition Receives: Procedure: scaling and root planing; Drug: hydroxylated poly methoxy flavones |
| Chlorohexidine group | Active comparator | SRP then Chlorohexidine gel application Receives: Procedure: scaling and root planing; Drug: chlorhexidine |
| placebo group | Placebo comparator | SRP then placebo gel application Receives: Procedure: scaling and root planing; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment loss will be quantified in centimeters before and after treatment
Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel than in other groups
Measured: One week
Pocket Depth will be quantified in centimeters before and after treatment
Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start20 Oct 2023 (estimated)
- Primary completion20 Nov 2023 (estimated)
- Study completion20 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups of patients with periodontitis, Group I received plain gel Group II received chlorhexidine gel Group III received hydroxylated polymethoxy flavones solid dispersion gel
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mortada, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546788
- Sponsor's protocol ID
- P.S.V.U 122/22
- Status last verified
- Oct 2023
- First submitted
- 4 Sep 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Hydroxylated Polymethoxy Flavones Solid Dispersion Incorporated Sodium Carboxymethyl Cellulose Gel With Periodontal Debridement in the Treatment of Periodontitis. Clinical- Biochemical Study
- ClinicalTrials.gov ID
- NCT05546788
- Acronym / sponsor ID
- P.S.V.U 122/22
- Conditions
- Inflammatory Disease, Periodontal Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 20 Nov 2023 (estimated)
- Study completion
- 20 Nov 2023 (estimated)
- First posted
- 21 Sep 2022 (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.
Periodontitis is a serious gum infection that damages the soft tissue and, without treatment, can destroy the bone that supports your teeth.
Hydroxylated poly methoxy flavones are a combination of naturally occurring flavonoids extracted from the orange peel and exert anti-inflammatory, antibacterial, and antifungal activity however, this extract is poorly soluble and poorly absorbable. In this work, this extract was formulated as a solid dispersion formulation to enhance its biological activity and then incorporated into a gel base and used in the treatment of periodontitis after clinical debridement.
Detailed description
In the study, there are 3 groups; the first one first one received plain sodium carboxymethylcellulose. Group II received chlorhexidine gel. GroupIII received Hydroxylated poly methoxy flavones solid dispersion incorporated into sodium carboxymethylcellulose gel.
In all groups, there is clinical debridement before injection of gels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
- Model description
- Three groups of patients with periodontitis, Group I received plain gel Group II received chlorhexidine gel Group III received hydroxylated polymethoxy flavones solid dispersion gel
| Arm | Type | Receives |
|---|---|---|
| hydroxylated polymethyl flavones group | Active comparator | Procedure: scaling and root planing, Drug: hydroxylated poly methoxy flavonesSRP then hydroxylated polymethyl flavones addition |
| Chlorohexidine group | Active comparator | Procedure: scaling and root planing, Drug: chlorhexidineSRP then Chlorohexidine gel application |
| placebo group | Placebo comparator | Procedure: scaling and root planing, Drug: placeboSRP then placebo gel application |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with periodontitis stage I-II
- free from any systemic disorders.
- no mobility - non-smokers - no parafunctional habits.
- Each patient with minimum three periodontitis sites ( split-mouth study)
Key exclusion criteria (2 listed)
- Smokers.
- patients with diabetes, and hypertension.
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 |
|---|---|---|
| scaling and root planingsubgingival Depridement | Procedure or surgery | Chlorohexidine group, hydroxylated polymethyl flavones group, placebo group |
| hydroxylated poly methoxy flavonesReceived hydroxylated poly methoxy flavones extract solid dispersion incorporated into sodium carboxymethylcellulose gel | Drug | hydroxylated polymethyl flavones group |
| chlorhexidineReceived chlorhexidine gel | Drug | Chlorohexidine group |
| placeboReceived placebo gel | Drug | placebo group |
Primary outcome
Clinical attachment loss will be quantified in centimeters before and after treatment
Time frame: One week
Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel than in other groups
Pocket Depth will be quantified in centimeters before and after treatment
Time frame: One week
Should be minimized in the group treated with Hydroxylated Polymethoxy Flavones gel
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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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 Phase 1 study testing scaling and root planing, hydroxylated poly methoxy flavones and chlorhexidine in people with Inflammatory Disease and Periodontal Diseases, run by Assiut University.
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 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 10 Oct 2023. 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 will be quantified in centimeters before and after treatment (time frame: One week). The study lists 2 primary outcomes in all. 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 10 Oct 2023.