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

NCT07404072 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: Ferulic acid in periodontitis
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

to clinical evaluation of locally applied Ferulic acid nanoparticles as an adjunct to mechanical debridement in treatment of periodontitis

Conditions

Periodontitis

Keywords

local drug delivery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Gingival Index (GI)

  Baseline and 3 months after treatment

• Change in Plaque Index (PI)

  Baseline and 3 months after treatment

Study Arms (4)

Ferulic Acid

ACTIVE COMPARATOR

Drug Group

Drug: Ferulic Acid

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Scaling only

OTHER

Procedure: mechanical debridement only

Healthy

NO INTERVENTION

Interventions

mechanical debridement only PROCEDURE

20 Patients will be treated with mechanical debridement only

Scaling only

Ferulic Acid DRUG

Group 1: 20 Patients will be treated with Ferulic acid nanoparticles gel as an adjunct to mechanical debridement.

Ferulic Acid

Placebo DRUG

20 Patients will be treated with placebo gel as an adjunct to mechanical debridement

Placebo

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Salah Awad Alanazi: lead
• Mansoura University: collaborator

Study Sites (1)

Mansura Universtiy

Al Mansurah, Mansura, 14323, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

ferulic acid

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: February 11, 2026
• Study Start: May 16, 2025
• Primary Completion: January 5, 2026
• Study Completion: February 15, 2026
• Last Updated: February 13, 2026

Record last verified: 2025-12

Locations

EG (1)