PeriodontitisPhase 1/2NCT07404072
Evaluation of Locally Applied Ferulic Acid as Adjunct to Mechanical Debridement in Treatment of Periodontitis
A Phase 1/2 study testing Ferulic Acid and mechanical debridement only in people with Periodontitis, run by Salah Awad Alanazi at 1 site in Egypt.
Trial summary
to clinical evaluation of locally applied Ferulic acid nanoparticles as an adjunct to mechanical debridement in treatment of periodontitis Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Ferulic Acid and mechanical debridement only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 16 May 2025to 15 Feb 2026
- Phase
- Phase 1/2
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of both sexes 25-55 y.
- Patients who are systemically healthy,
- Patient exhibiting periodontal pocket depths (PD) ≥5mm,
- Presence of clinical attachment loss (CAL) between 3-4mm,
- Cooperative individuals capable of adhering to mechanical oral hygiene instructions
Who cannot join
- nPatients with sensitivity to the medication used in the study,
- Patients with a history of antibiotic use or anti-inflammatory drugs during the previous 3 months prior to the study,
- Patients with systemic diseases,
- Pregnant and lactating females,
- Smokers and tobacco chewers,
- Patients are not compliant with oral hygiene procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Locally Applied Ferulic Acid as Adjunct to Mechanical Debridement in Treatment of Periodontitis (Clinical and Laboratory Study)
to clinical evaluation of locally applied Ferulic acid nanoparticles as an adjunct to mechanical debridement in treatment of periodontitis
Read the detailed description
Periodontitis is a complex chronic multifactorial inflammatory disease that impacts the tissues supporting teeth, causing their progressive destruction. It is initiated by bacterial infection, primarily involving Gram-negative anaerobic bacteria that trigger an immune response and production of pro-inflammatory cytokines. These cytokines recruit numerous neutrophils and macrophages to the site of infection resulting in the release of reactive oxygen species (ROS) and thus worsens tissue damage. Additionally, systemic diseases like diabetes mellitus or behaviors like smoking are examples of exacerbating factors .
Periodontitis remains a significant public health issue as it is the main cause of tooth loss and chewing dysfunction. This condition has far-reaching implications, affecting not only an individual's ability to maintain proper nutrition but also their quality of life and self-esteem. The impact of periodontitis extends beyond personal health, creating substantial socioeconomic burdens and escalating medical costs .
Therefore, effective treatment and management of periodontitis are crucial to mitigating these adverse effects and improving overall well-being. Tailored treatment approaches are essential, primarily focused on controlling the patient's infection. Supra- and subgingival instrumentation, commonly referred to as scaling and root planing (SRP), along with diligent home dental care, have an important role in managing the infection in patients diagnosed with periodontitis .
Systemic drugs used as adjuncts to SRP aim to enhance periodontal treatment outcomes by targeting bacterial pathogens or modulating the host immune response. Common systemic adjuncts include antibiotics, such as amoxicillin and metronidazole, which result in improvement in the clinical attachment levels (CAL) and reduction in periodontal probing depth (PPD) in chronic periodontitis patients. However, their prolonged use can lead to antibiotic resistance, gastrointestinal discomfort, and allergic reactions . Additionally, host-modulating agents, like sub-antimicrobial-dose doxycycline (SDD), inhibit matrix metalloproteinases (MMPs), reducing inflammation and tissue breakdown, but may cause photosensitivity or gastrointestinal issues with long-term use . Nonsteroidal anti-inflammatory drugs (NSAIDs) can also decrease bone resorption but are associated with gastrointestinal and cardiovascular side effects . While systemic drugs can augment SRP efficacy, their side effects and the potential for resistance necessitate careful patient selection and judicious use .
Optimizing the effectiveness of pharmacological therapy while minimizing risks and controlling the release of the drug is crucial. That's why a local drug delivery system (LDDS) is recommended in combination with SRP. LDDS shows promise in treating localized infections in various body parts and serves as a valuable tool for adjunctive local pharmacological therapy in periodontal treatment. LDDSs regulate the discharge of locally administered drugs meant to supplement periodontal treatment .
Ferulic acid, known as 4-hydroxy-3-methoxycinnamic acid, is a phenolic compound naturally found in various plants, including cereals, fruits, vegetables, and Chinese herbal medicines. It is known for its potent antioxidant properties, which help neutralize harmful free radicals and reduce oxidative stress. It also has numerous physiological properties, including anti-inflammatory, antioxidant, antibacterial, and anticancer, with low toxicity . In addition to being a free radical scavenger, ferulic acid also inhibits the enzymes that cause free radicals to form and increases the activity of scavenging enzymes . In addition, it is frequently used in skin care products as a brightening ingredient, photoprotective agent, and skin photoaging delayer .
Furthering, ferulic acid is one of the most important roles of phenolic acids, especially cinnamic acid derivatives, is their antioxidant activity, which depends primarily on the number of hydroxyl and methoxy groups attached to the phenyl ring. Ferulic acid is more easily absorbed into the body and stays in the blood longer than any other phenolic acids. Therefore, it is considered to be a superior antioxidant .
Hence, this study aimed to assess the validity of locally delivered ferulic acid nanoparticles as an adjunct to mechanical debridement for managing periodontitis.
- Conditions
- Periodontitis
- Being tested
- Ferulic Acid, Placebo, mechanical debridement only
- Keywords
- local drug delivery
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferulic AcidDrug
Group 1: 20 Patients will be treated with Ferulic acid nanoparticles gel as an adjunct to mechanical debridement.
PlaceboDrug
20 Patients will be treated with placebo gel as an adjunct to mechanical debridement
mechanical debridement onlyProcedure or surgery
20 Patients will be treated with mechanical debridement only
| Study group | Role | What they receive |
|---|---|---|
| Ferulic Acid | Active comparator | Drug Group Receives: Drug: Ferulic Acid |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Scaling only | Other | Not described Receives: Procedure: mechanical debridement only |
| Healthy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Probing Pocket Depth (PPD)
Assessment of changes in probing pocket depth at selected periodontal sites to evaluate the clinical effectiveness of locally applied ferulic acid as an adjunct to mechanical debridement in patients with periodontitis.
Measured: Baseline and 3 months after treatment
Change in Clinical Attachment Loss (CAL)
Evaluation of changes in clinical attachment loss to determine periodontal tissue response following adjunctive treatment with locally applied ferulic acid.
Measured: Baseline and 3 months after treatment
Secondary outcomes (2)
Change in Gingival Index (GI)
Measurement of gingival inflammation severity using the Gingival Index to assess the anti-inflammatory effect of locally applied ferulic acid.
Measured: Baseline and 3 months after treatment
Change in Plaque Index (PI)
Assessment of dental plaque accumulation using the Plaque Index to evaluate changes in oral hygiene status following treatment.
Measured: Baseline and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start16 May 2025
- Primary completion5 Jan 2026
- Study completion15 Feb 2026 (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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salah Awad Alanazi
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Sponsor-investigator, Salah Awad Alanazi, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404072
- Sponsor's protocol ID
- Ferulic acid in periodontitis
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Locally Applied Ferulic Acid as Adjunct to Mechanical Debridement in Treatment of Periodontitis (Clinical and Laboratory Study)
- ClinicalTrials.gov ID
- NCT07404072
- Acronym / sponsor ID
- Ferulic acid in periodontitis
- Conditions
- Periodontitis
- Keywords
- local drug delivery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Salah Awad AlanaziUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- 16 May 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 11 Feb 2026 (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 clinical evaluation of locally applied Ferulic acid nanoparticles as an adjunct to mechanical debridement in treatment of periodontitis
Detailed description
Periodontitis is a complex chronic multifactorial inflammatory disease that impacts the tissues supporting teeth, causing their progressive destruction. It is initiated by bacterial infection, primarily involving Gram-negative anaerobic bacteria that trigger an immune response and production of pro-inflammatory cytokines. These cytokines recruit numerous neutrophils and macrophages to the site of infection resulting in the release of reactive oxygen species (ROS) and thus worsens tissue damage. Additionally, systemic diseases like diabetes mellitus or behaviors like smoking are examples of exacerbating factors .
Periodontitis remains a significant public health issue as it is the main cause of tooth loss and chewing dysfunction. This condition has far-reaching implications, affecting not only an individual's ability to maintain proper nutrition but also their quality of life and self-esteem. The impact of periodontitis extends beyond personal health, creating substantial socioeconomic burdens and escalating medical costs .
Therefore, effective treatment and management of periodontitis are crucial to mitigating these adverse effects and improving overall well-being. Tailored treatment approaches are essential, primarily focused on controlling the patient's infection. Supra- and subgingival instrumentation, commonly referred to as scaling and root planing (SRP), along with diligent home dental care, have an important role in managing the infection in patients diagnosed with periodontitis .
Systemic drugs used as adjuncts to SRP aim to enhance periodontal treatment outcomes by targeting bacterial pathogens or modulating the host immune response. Common systemic adjuncts include antibiotics, such as amoxicillin and metronidazole, which result in improvement in the clinical attachment levels (CAL) and reduction in periodontal probing depth (PPD) in chronic periodontitis patients. However, their prolonged use can lead to antibiotic resistance, gastrointestinal discomfort, and allergic reactions . Additionally, host-modulating agents, like sub-antimicrobial-dose doxycycline (SDD), inhibit matrix metalloproteinases (MMPs), reducing inflammation and tissue breakdown, but may cause photosensitivity or gastrointestinal issues with long-term use . Nonsteroidal anti-inflammatory drugs (NSAIDs) can also decrease bone resorption but are associated with gastrointestinal and cardiovascular side effects . While systemic drugs can augment SRP efficacy, their side effects and the potential for resistance necessitate careful patient selection and judicious use .
Optimizing the effectiveness of pharmacological therapy while minimizing risks and controlling the release of the drug is crucial. That's why a local drug delivery system (LDDS) is recommended in combination with SRP. LDDS shows promise in treating localized infections in various body parts and serves as a valuable tool for adjunctive local pharmacological therapy in periodontal treatment. LDDSs regulate the discharge of locally administered drugs meant to supplement periodontal treatment .
Ferulic acid, known as 4-hydroxy-3-methoxycinnamic acid, is a phenolic compound naturally found in various plants, including cereals, fruits, vegetables, and Chinese herbal medicines. It is known for its potent antioxidant properties, which help neutralize harmful free radicals and reduce oxidative stress. It also has numerous physiological properties, including anti-inflammatory, antioxidant, antibacterial, and anticancer, with low toxicity . In addition to being a free radical scavenger, ferulic acid also inhibits the enzymes that cause free radicals to form and increases the activity of scavenging enzymes . In addition, it is frequently used in skin care products as a brightening ingredient, photoprotective agent, and skin photoaging delayer .
Furthering, ferulic acid is one of the most important roles of phenolic acids, especially cinnamic acid derivatives, is their antioxidant activity, which depends primarily on the number of hydroxyl and methoxy groups attached to the phenyl ring. Ferulic acid is more easily absorbed into the body and stays in the blood longer than any other phenolic acids. Therefore, it is considered to be a superior antioxidant .
Hence, this study aimed to assess the validity of locally delivered ferulic acid nanoparticles as an adjunct to mechanical debridement for managing periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ferulic Acid | Active comparator | Drug: Ferulic AcidDrug Group |
| Placebo | Placebo comparator | Drug: Placebo |
| Scaling only | Other | Procedure: mechanical debridement only |
| Healthy | No intervention | – |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients of both sexes 25-55 y.
- Patients who are systemically healthy,
- Patient exhibiting periodontal pocket depths (PD) ≥5mm,
- Presence of clinical attachment loss (CAL) between 3-4mm,
- Cooperative individuals capable of adhering to mechanical oral hygiene instructions
Key exclusion criteria (6 listed)
- nPatients with sensitivity to the medication used in the study,
- Patients with a history of antibiotic use or anti-inflammatory drugs during the previous 3 months prior to the study,
- Patients with systemic diseases,
- Pregnant and lactating females,
- Smokers and tobacco chewers,
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 |
|---|---|---|
| Ferulic AcidGroup 1: 20 Patients will be treated with Ferulic acid nanoparticles gel as an adjunct to mechanical debridement. | Drug | Ferulic Acid |
| Placebo20 Patients will be treated with placebo gel as an adjunct to mechanical debridement | Drug | Placebo |
| mechanical debridement only20 Patients will be treated with mechanical debridement only | Procedure or surgery | Scaling only |
Primary outcome
Change in Probing Pocket Depth (PPD)
Time frame: Baseline and 3 months after treatment
Assessment of changes in probing pocket depth at selected periodontal sites to evaluate the clinical effectiveness of locally applied ferulic acid as an adjunct to mechanical debridement in patients with periodontitis.
Change in Clinical Attachment Loss (CAL)
Time frame: Baseline and 3 months after treatment
Evaluation of changes in clinical attachment loss to determine periodontal tissue response following adjunctive treatment with locally applied ferulic acid.
2 secondary outcomes
Change in Gingival Index (GI)
Time frame: Baseline and 3 months after treatment
Change in Plaque Index (PI)
Time frame: Baseline and 3 months after treatment
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 13 Feb 2026.
- 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 Phase 1/2 study testing Ferulic Acid and mechanical debridement only in people with Periodontitis, run by Salah Awad Alanazi 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 6 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 13 Feb 2026. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Probing Pocket Depth (PPD) (time frame: Baseline and 3 months after treatment). 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 13 Feb 2026.