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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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.

Egypt1 site
  • Mansura Universtiy

    Al Mansurah, Mansura, 14323

Other trials in Egypt

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 groups in NCT07404072
Study groupRoleWhat they receive
Ferulic AcidActive comparatorDrug Group
Receives: Drug: Ferulic Acid
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Scaling onlyOtherNot described
Receives: Procedure: mechanical debridement only
HealthyNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)
  1. 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

  2. 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.

  1. First posted11 Feb 2026
  2. Study start16 May 2025
  3. Primary completion5 Jan 2026
  4. Study completion15 Feb 2026 (estimated)

Resources

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)
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

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.

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