PeriodontitisEarly Phase 1NCT06653231
Assessment the Efficacy of Curcumin Local Delivery Gel in Treatment of Periodontitis in Smokers
A Early Phase 1 study testing local delivery of Curcumin gel in people with Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
Smokers usually respond less favourably to non-surgical periodontal treatment compared to non-smokers. Numerous studies reported that smoker patients exhibited less reduction in probing depth and less gains in clinical attachment level values following scaling and root planing (Kanmaz et al., 2021, Alwithanani, 2023)… Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- local delivery of Curcumin gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 1 Mar 2025
- Phase
- Early 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients diagnosed with generalized periodontitis with stage II
- Nonsurgical or surgical periodontal therapy in the last 3 months were considered as eligible for the study.
- Current smoker or smoker over the past 5 years.
Who cannot join
- Presence of overhanging restorations,
- antibiotics or any form of periodontal therapy in the previous 6 months.
- History of systemic disease, cardiovascular diseases, diabetes mellitus, hypertension, bleeding disorders, hyperparathyroidism, and compromised medical conditions, pregnancy and lactation.
- Teeth with both endo-perio lesions.
- Patient on antibiotics within 3 months prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment the Efficacy of Curcumin Local Delivery Gel in Treatment of Periodontitis in Smokers. Randomized Controlled Clinical Trial
Smokers usually respond less favourably to non-surgical periodontal treatment compared to non-smokers. Numerous studies reported that smoker patients exhibited less reduction in probing depth and less gains in clinical attachment level values following scaling and root planing (Kanmaz et al., 2021, Alwithanani, 2023)
Several studies have proposed the use of adjunctive treatment approaches such as local/systemic antimicrobials and anti-inflammatory agents to improve the effects of basic periodontal therapy in smokers. However, no studies have been published evaluated the conventional management of topically delivered curcumin gel in conjunction with scaling and root planing demonstrating its ability to improve periodontal outcomes in smokers.
Meanwhile, some clinical trials indicate that local and systemic administration of curcumin can enhance the results of SRP in periodontal treatment. Local delivery allows higher concentrations of the active compounds in the diseased site and avoids possible adverse effects of systemic administration.
Read the detailed description
Tobacco use increases the risk and progression of periodontitis by multiple factors including decreased gingival perfusion, which restricts nutrients and oxygen delivery as well as the removal of waste products. In addition, it affects the circulating levels of immune-inflammatory cells in gingival crevicular fluid, and affects the dysbiosis microbiota reducing the ability of the periodontium to repair.
Curcumin is an extract from the turmeric plant Curcuma longa L. It has been shown potent anti-microbial, anti-carcinogenic, antiviral, antioxidant, and anti-inflammatory properties.
In periodontitis, curcumin plays a pivotal role in anti-inflammatory properties, by inhibiting pro-inflammatory cytokines, reducing the prostaglandin biosynthesis, inhibiting the mRNA and protein expression of cyclo-oxygenase-2, through down-regulation of NF-kB activation.
Meanwhile, some clinical trials indicate that local and systemic administration of curcumin can enhance the results of SRP in periodontal treatment; local delivery allows higher concentrations of the active compounds in the diseased site and avoids possible adverse effects of systemic administration (Pérez-Pacheco et al., 2021, Borgohain et al., 2023, Chatzopoulos et al., 2023).
- Conditions
- Periodontitis
- Being tested
- local delivery of Curcumin gel
- Keywords
- curcumin, local delivery gel, smokers, periodontitis, RCT
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local delivery of Curcumin gelDrug
Also called turmeric plant Curcuma longa L
The test site will be completely undiluted curcumin gel through a 2 mL disposable syringe was placed in the test site
| Study group | Role | What they receive |
|---|---|---|
| SRP with local delivery of Curcumin gel | Experimental | Scaling and root planing in combination with local delivery of Curcumin gel Receives: Drug: local delivery of Curcumin gel |
| SRP alone | Active comparator | Scaling and root plaing alone Receives: Drug: local delivery of Curcumin gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
probing pocket depth
The depth of the pocket will be measured from the gingival margin to the base of the pocket.
Measured: 45 days
clinical attachment level
The clinical attachment level will be measured from the CEJ to the base of pocket.
Measured: 45 days
Secondary outcomes (2)
gingival index
Score 0 normal gingiva and no inflammation Score 1 mild inflammation with a slight change in colour, slight oedema, no bleeding on probing.
Score 2 moderate inflammation with redness, oedema and glazing or bleeding on probing.
Score 3 severe inflammation with marked redness and hypertrophy and a tendency toward spontaneous bleeding and ulceration.
Measured: 45 days
Paque index
Score 0 no plaque Score 1 A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye but only by using disclosing solution or probe.
Score 2 Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen with the naked eye.
Score 3 Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Nov 2024
- Primary completion1 Feb 2025
- Study completion1 Mar 2025
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 Cairo 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parryhan Mohamed Abdelsamie, Cairo University
- Investigators
- Parryhan M Abdelsamie, Principal investigator, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653231
- Sponsor's protocol ID
- 102024
- Status last verified
- Jul 2025
- First submitted
- 20 Oct 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment the Efficacy of Curcumin Local Delivery Gel in Treatment of Periodontitis in Smokers. Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06653231
- Acronym / sponsor ID
- 102024
- Conditions
- Periodontitis
- Keywords
- curcumin, local delivery gel, smokers, periodontitis, RCT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 22 Oct 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.
Smokers usually respond less favourably to non-surgical periodontal treatment compared to non-smokers. Numerous studies reported that smoker patients exhibited less reduction in probing depth and less gains in clinical attachment level values following scaling and root planing (Kanmaz et al., 2021, Alwithanani, 2023)
Several studies have proposed the use of adjunctive treatment approaches such as local/systemic antimicrobials and anti-inflammatory agents to improve the effects of basic periodontal therapy in smokers. However, no studies have been published evaluated the conventional management of topically delivered curcumin gel in conjunction with scaling and root planing demonstrating its ability to improve periodontal outcomes in smokers.
Meanwhile, some clinical trials indicate that local and systemic administration of curcumin can enhance the results of SRP in periodontal treatment. Local delivery allows higher concentrations of the active compounds in the diseased site and avoids possible adverse effects of systemic administration.
Detailed description
Tobacco use increases the risk and progression of periodontitis by multiple factors including decreased gingival perfusion, which restricts nutrients and oxygen delivery as well as the removal of waste products. In addition, it affects the circulating levels of immune-inflammatory cells in gingival crevicular fluid, and affects the dysbiosis microbiota reducing the ability of the periodontium to repair.
Curcumin is an extract from the turmeric plant Curcuma longa L. It has been shown potent anti-microbial, anti-carcinogenic, antiviral, antioxidant, and anti-inflammatory properties.
In periodontitis, curcumin plays a pivotal role in anti-inflammatory properties, by inhibiting pro-inflammatory cytokines, reducing the prostaglandin biosynthesis, inhibiting the mRNA and protein expression of cyclo-oxygenase-2, through down-regulation of NF-kB activation.
Meanwhile, some clinical trials indicate that local and systemic administration of curcumin can enhance the results of SRP in periodontal treatment; local delivery allows higher concentrations of the active compounds in the diseased site and avoids possible adverse effects of systemic administration (Pérez-Pacheco et al., 2021, Borgohain et al., 2023, Chatzopoulos et al., 2023).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRP with local delivery of Curcumin gel | Experimental | Drug: local delivery of Curcumin gelScaling and root planing in combination with local delivery of Curcumin gel |
| SRP alone | Active comparator | Drug: local delivery of Curcumin gelScaling and root plaing alone |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients diagnosed with generalized periodontitis with stage II
- Nonsurgical or surgical periodontal therapy in the last 3 months were considered as eligible for the study.
- Current smoker or smoker over the past 5 years.
Key exclusion criteria (5 listed)
- Presence of overhanging restorations,
- antibiotics or any form of periodontal therapy in the previous 6 months.
- History of systemic disease, cardiovascular diseases, diabetes mellitus, hypertension, bleeding disorders, hyperparathyroidism, and compromised medical conditions, pregnancy and lactation.
- Teeth with both endo-perio lesions.
- Patient on antibiotics within 3 months prior to the study.
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 |
|---|---|---|
| local delivery of Curcumin gelAlso: turmeric plant Curcuma longa LThe test site will be completely undiluted curcumin gel through a 2 mL disposable syringe was placed in the test site | Drug | SRP alone, SRP with local delivery of Curcumin gel |
Primary outcome
probing pocket depth
Time frame: 45 days
The depth of the pocket will be measured from the gingival margin to the base of the pocket.
clinical attachment level
Time frame: 45 days
The clinical attachment level will be measured from the CEJ to the base of pocket.
2 secondary outcomes
gingival index
Time frame: 45 days
Paque index
Time frame: 45 days
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 18 Jul 2025.
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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.
Parryhan M Abdelsamie principal investigator
MTI University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing local delivery of Curcumin gel in people with Periodontitis, run by Cairo 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 3 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 18 Jul 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
probing pocket depth (time frame: 45 days). 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 18 Jul 2025.