Evaluation of Locally Applied Ferulic Acid as Adjunct to Mechanical Debridement in Treatment of Periodontitis

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

Study Overview

• Status: Active, not recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Drug: Ferulic Acid; Drug: Placebo; Procedure: mechanical debridement only

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Mansura
    • Al Mansurah, Mansura, Egypt, 14323
      • Mansura Universtiy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 20 Patients will be treated with placebo gel as an adjunct to mechanical debridement
No Intervention: Healthy
Active Comparator: Ferulic Acid; Drug Group	Drug: Ferulic Acid; Group 1: 20 Patients will be treated with Ferulic acid nanoparticles gel as an adjunct to mechanical debridement.
Other: Scaling only	Procedure: mechanical debridement only; 20 Patients will be treated with mechanical debridement only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline and 3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline and 3 months after treatment

Collaborators and Investigators

• Sponsor: Salah Awad Alanazi
• Collaborators: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2025
• Primary Completion (Actual): January 5, 2026
• Study Completion (Estimated): February 15, 2026

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: local drug delivery
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; ferulic acid
• Other Study ID Numbers: Ferulic acid in periodontitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No