PeriodontitisNCT06777303
Efficacy of Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis
A study testing curcurmin loaded on chitosan nano-particles, hyaluronic acid loaded on chitosan nano-particles and scaling and root planning in people with Periodontitis, run by Mansoura University at 1 site in Egypt.
Trial summary
to evaluate Efficacy of Locally Applied Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis patients Materials and methods: forty patients (n=40) were selected from the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periodontitis
- What is being tested?
- curcurmin loaded on chitosan nano-particles, hyaluronic acid loaded on chitosan nano-particles and scaling and root planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jun 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are systemically healthy
- Patient exhibiting periodontal pocket depths (PD) ≤5mm
- presence of clinical attachment loss (CAL) between 1-4mm
- cooperative individuals capable of adhering to mechanical oral hygiene instructions
- Patients who agreed on both written and verbal consent to participate in the study.
Who cannot join
- patients with recent history of periodontal treatment (within the last 3 months)
- patients with recent use of antibiotic (within the past 3 months)
- pregnant or lactating women,
- individuals who are malnourished and taking vitamin supplements,
- Patients who regularly use mouthwashes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Locally Applied Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis Patients
to evaluate Efficacy of Locally Applied Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis patients
Materials and methods: forty patients (n=40) were selected from the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University, The participants forty patients are classified into four groups:
Read more
- Group1 : (-ve control group): SRP alone
- Group2: (+ve control group): SRP+ chitosan Nano-particles
- Group3: SRP + Curcumin-coated chitosan Nano-particles
- Group4: SRP+ hyaluronic acid -coated chitosan Nano-particle
All Patients will undergo Phase I therapy, which includes scaling and root planing using ultrasonic tips and gracey curettes. Additionally, mechanical oral hygiene instructions will be provided, and participants will be advised to refrain from using any mouthwash throughout the duration of the study.
Furthermore, patients within groups 2 to 4 will be subjected to an extra measure involving the application of the respective gel associated with their designated group. The gel will be administered on a weekly basis for duration of five weeks.
Clinical indices (plaque index (PI), gingival index (GI), clinical attachment level (CAL), and probing depth (PD)). Laboratory assessment will be done at baseline and final assessment( after 3 months) . tess will be for antioxdiant levels and TNF alpha
- Total anti-oxidant capacity(T-AOC) using Assay kit50T
- TNF alpha using ELISA Kit (96T)
Read the detailed description
Inclusion criteria:
Patients who are systemically healthy Patient exhibiting periodontal pocket depths (PD) ≤5mm presence of clinical attachment loss (CAL) between 1-4mm cooperative individuals capable of adhering to mechanical oral hygiene instructions Patients who agreed on both written and verbal consent to participate in the study.
6
- Exclusion criteria: patients with recent history of periodontal treatment (within the last 3 months) patients with recent use of antibiotic (within the past 3 months, pregnant or lactating women, individuals who are malnourished and taking vitamin supplements, Patients who regularly use mouthwashes.
Method of gel application: a blunt 2ml syringe will be used to administer the gel sub-gingivally until the pocket is filled
Cervicular fluid collection :
This is done at baseline and after 12 weeks
- Insert absorbent paper points gently into the gingival crevice at the sulcus or pocket depth.
- Allow the absorbent material to remain in the crevice for a specific duration (1 minute) to enable the collection of gingival crevicular fluid.
- Carefully retrieve the paper points from the gingival crevice, ensuring that the collected fluid is preserved on the material.
- Place the paper points in eppendorf tubes
- Handle the samples with care to prevent contamination and promptly transport them to the laboratory for further analysis. If necessary, samples may undergo centrifugation to separate cells and debris from the fluid.
Periodontal assessment:
The following periodontal indices will be assessed at baseline, and after 12 weeks o Plaque Index according to Silness P. Loe H 1964
- Gingival Bleeding Index/Bleeding On Probing(BOP) according to Ainamo \& Bay 1975
- Probing pocket depth (PPD) is measured from free gingival margin to base of the pocket.
- Clinical attachment loss (CAL) is measured from cemento-enemal junction to base of the pocket. the determination of the sample size was guided by reference of similar articles. . Employing G power for the calculation, the sample size was determined with a 0.676 effect size, a two-tailed test, α error set at 0.05, and a power of 0.8, resulting in a total calculated sample size of 10 individuals in each group.
Pretreatment period Participants were informed about the purpose of the study and screened for eligibility. They also were informed about the treatment received and the steps done, including non-surgical treatment and gel application with the associated risks, possible effects, and other treatment options available. The participants understood this explanation in broad terms according to the rules of the ethical committee of the Faculty of Dentistry, Mansoura University. Additionally, they acknowledged that they would be required to attend the periodic recall visits and that they are legally competent to give written informed consent before performing any required steps.
- Conditions
- Periodontitis
- Being tested
- curcurmin loaded on chitosan nano-particles, hyaluronic acid loaded on chitosan nano-particles, scaling and root planning, chitosan nano-particles
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcurmin loaded on chitosan nano-particlesDrug
the formulation of curcumin and incorprating it with chitosan nano-particles will increase the absorption rate in the gingival sulcus
hyaluronic acid loaded on chitosan nano-particlesDrug
the formulation of hyaluronic acid and incorprating it with chitosan nano-particles will increase the absorption rate in the gingival sulcus
scaling and root planningProcedure or surgery
the -ve control group in the study
chitosan nano-particlesDrug
the +ve control group in the study
| Study group | Role | What they receive |
|---|---|---|
| group 1 (-ve control group) SRP alone | Active comparator | are treated with scaling and root planning alone Receives: Procedure: scaling and root planning |
| group 2 ( +ve control group) SRP + chitosan nano-particles LDD | Active comparator | patients are treated with SRP in addition to chitosan nano-particles as an adjunct local drug delivery. Receives: Drug: chitosan nano-particles |
| group 3 ( experimental group 1) SRP + curcumin loaded on chitosan nano-particles | Experimental | patients are treated with SRP in addition to curcumin loaded on chitosan nano-particles as an adjunct local drug delivery. Receives: Drug: curcurmin loaded on chitosan nano-particles |
| group 4 ( experimental group 2) SRP + hyaluronic acid loaded on chitosan nano-particles | Experimental | patients are treated with SRP in addition to hyaluronic-acid loaded on chitosan nano-particles as an adjunct local drug delivery. Receives: Drug: hyaluronic acid loaded on chitosan nano-particles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth reduction
pocket depth is calculated using a UNC 15 perio probe to calculate the distance between the base of the pocket to the free gingival margin
Measured: 12 weeks
Secondary outcomes (5)
plaque index
according to Silness P. Loe H 1964
Measured: 12 weeks
clinical attachment gain
measured from cemento-enemal junction to base of the pocket
Measured: 12 weeks
Gingival Bleeding Index
according to Ainamo \& Bay 1975
Measured: 12 weeks
o Total anti-oxidant capacity(T-AOC)
laboratory investigation using Assay kit50T
Measured: 12 weeks
tumor necrosis factor alpha (TNF alpha)
laboratory investigation using ELISA Kit (96T)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start2 Jun 2024
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777303
- Sponsor's protocol ID
- A05010240M
- Status last verified
- May 2025
- First submitted
- 10 Jan 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Locally Applied Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis Patients
- ClinicalTrials.gov ID
- NCT06777303
- Acronym / sponsor ID
- A05010240M
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 2 Jun 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 15 Jan 2025 (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.
to evaluate Efficacy of Locally Applied Nano-Curcumin and Nano-Hyaluronic Acid as an Adjunct to Scaling and Root Planing in the Treatment of Periodontitis patients
Materials and methods: forty patients (n=40) were selected from the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University, The participants forty patients are classified into four groups:
- Group1 : (-ve control group): SRP alone
- Group2: (+ve control group): SRP+ chitosan Nano-particles
- Group3: SRP + Curcumin-coated chitosan Nano-particles
- Group4: SRP+ hyaluronic acid -coated chitosan Nano-particle
All Patients will undergo Phase I therapy, which includes scaling and root planing using ultrasonic tips and gracey curettes. Additionally, mechanical oral hygiene instructions will be provided, and participants will be advised to refrain from using any mouthwash throughout the duration of the study.
Furthermore, patients within groups 2 to 4 will be subjected to an extra measure involving the application of the respective gel associated with their designated group. The gel will be administered on a weekly basis for duration of five weeks.
Clinical indices (plaque index (PI), gingival index (GI), clinical attachment level (CAL), and probing depth (PD)). Laboratory assessment will be done at baseline and final assessment( after 3 months) . tess will be for antioxdiant levels and TNF alpha
- Total anti-oxidant capacity(T-AOC) using Assay kit50T
- TNF alpha using ELISA Kit (96T)
Detailed description
Inclusion criteria:
Patients who are systemically healthy Patient exhibiting periodontal pocket depths (PD) ≤5mm presence of clinical attachment loss (CAL) between 1-4mm cooperative individuals capable of adhering to mechanical oral hygiene instructions Patients who agreed on both written and verbal consent to participate in the study.
6
- Exclusion criteria: patients with recent history of periodontal treatment (within the last 3 months) patients with recent use of antibiotic (within the past 3 months, pregnant or lactating women, individuals who are malnourished and taking vitamin supplements, Patients who regularly use mouthwashes.
Method of gel application: a blunt 2ml syringe will be used to administer the gel sub-gingivally until the pocket is filled
Cervicular fluid collection :
This is done at baseline and after 12 weeks
- Insert absorbent paper points gently into the gingival crevice at the sulcus or pocket depth.
- Allow the absorbent material to remain in the crevice for a specific duration (1 minute) to enable the collection of gingival crevicular fluid.
- Carefully retrieve the paper points from the gingival crevice, ensuring that the collected fluid is preserved on the material.
- Place the paper points in eppendorf tubes
- Handle the samples with care to prevent contamination and promptly transport them to the laboratory for further analysis. If necessary, samples may undergo centrifugation to separate cells and debris from the fluid.
Periodontal assessment:
The following periodontal indices will be assessed at baseline, and after 12 weeks o Plaque Index according to Silness P. Loe H 1964
- Gingival Bleeding Index/Bleeding On Probing(BOP) according to Ainamo \& Bay 1975
- Probing pocket depth (PPD) is measured from free gingival margin to base of the pocket.
- Clinical attachment loss (CAL) is measured from cemento-enemal junction to base of the pocket. the determination of the sample size was guided by reference of similar articles. . Employing G power for the calculation, the sample size was determined with a 0.676 effect size, a two-tailed test, α error set at 0.05, and a power of 0.8, resulting in a total calculated sample size of 10 individuals in each group.
Pretreatment period Participants were informed about the purpose of the study and screened for eligibility. They also were informed about the treatment received and the steps done, including non-surgical treatment and gel application with the associated risks, possible effects, and other treatment options available. The participants understood this explanation in broad terms according to the rules of the ethical committee of the Faculty of Dentistry, Mansoura University. Additionally, they acknowledged that they would be required to attend the periodic recall visits and that they are legally competent to give written informed consent before performing any required steps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 (-ve control group) SRP alone | Active comparator | Procedure: scaling and root planningare treated with scaling and root planning alone |
| group 2 ( +ve control group) SRP + chitosan nano-particles LDD | Active comparator | Drug: chitosan nano-particlespatients are treated with SRP in addition to chitosan nano-particles as an adjunct local drug delivery. |
| group 3 ( experimental group 1) SRP + curcumin loaded on chitosan nano-particles | Experimental | Drug: curcurmin loaded on chitosan nano-particlespatients are treated with SRP in addition to curcumin loaded on chitosan nano-particles as an adjunct local drug delivery. |
| group 4 ( experimental group 2) SRP + hyaluronic acid loaded on chitosan nano-particles | Experimental | Drug: hyaluronic acid loaded on chitosan nano-particlespatients are treated with SRP in addition to hyaluronic-acid loaded on chitosan nano-particles as an adjunct local drug delivery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are systemically healthy
- Patient exhibiting periodontal pocket depths (PD) ≤5mm
- presence of clinical attachment loss (CAL) between 1-4mm
- cooperative individuals capable of adhering to mechanical oral hygiene instructions
- Patients who agreed on both written and verbal consent to participate in the study.
Key exclusion criteria (5 listed)
- patients with recent history of periodontal treatment (within the last 3 months)
- patients with recent use of antibiotic (within the past 3 months)
- pregnant or lactating women,
- individuals who are malnourished and taking vitamin supplements,
- Patients who regularly use mouthwashes.
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 |
|---|---|---|
| curcurmin loaded on chitosan nano-particlesthe formulation of curcumin and incorprating it with chitosan nano-particles will increase the absorption rate in the gingival sulcus | Drug | group 3 ( experimental group 1) SRP + curcumin loaded on chitosan nano-particles |
| hyaluronic acid loaded on chitosan nano-particlesthe formulation of hyaluronic acid and incorprating it with chitosan nano-particles will increase the absorption rate in the gingival sulcus | Drug | group 4 ( experimental group 2) SRP + hyaluronic acid loaded on chitosan nano-particles |
| scaling and root planningthe -ve control group in the study | Procedure or surgery | group 1 (-ve control group) SRP alone |
| chitosan nano-particlesthe +ve control group in the study | Drug | group 2 ( +ve control group) SRP + chitosan nano-particles LDD |
Primary outcome
Probing pocket depth reduction
Time frame: 12 weeks
pocket depth is calculated using a UNC 15 perio probe to calculate the distance between the base of the pocket to the free gingival margin
5 secondary outcomes
plaque index
Time frame: 12 weeks
clinical attachment gain
Time frame: 12 weeks
Gingival Bleeding Index
Time frame: 12 weeks
o Total anti-oxidant capacity(T-AOC)
Time frame: 12 weeks
tumor necrosis factor alpha (TNF alpha)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing curcurmin loaded on chitosan nano-particles, hyaluronic acid loaded on chitosan nano-particles and scaling and root planning in people with Periodontitis, run by Mansoura University 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 5 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Probing pocket depth reduction (time frame: 12 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 20 May 2025.