Efficacy and Safety of DKF-306 in Patients With Periodontal Diseases

A Multi-center, Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of DKF-306 in Patients With Periodontal Diseases

This is a multi-center, randomized, double-blinded, placebo-controlled study to evaluated the efficacy and safety of DKF-306 in patients with periodontal diseases.

Study Overview

• Status: Recruiting
• Conditions: Periodontal Diseases
• Intervention / Treatment: Drug: Placebo; Drug: DKF-306

• Study Type: Interventional
• Enrollment (Anticipated): 158
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Young-Sung Kim; Phone Number: +82-2-3010-5987; Email: dumber73@mail.ulsan.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Youngsung
    • Contact: Young-Sung Kim, M.D.; Phone Number: +82-2-3010-5987; Email: dumber73@mail.ulsan.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 19 years and older
• Periodontal diseases
• Having not less than 16 permanent teeth including at least 4 molars (third molars excluded)
• Having teeth with not less than 2 sites of both probing pocket depth (PPD) ≥ 4 mm and gingival index (GI) ≥ 2 in at least 2 quadrants
• Agrees not to use over-the-counters (oral, ointment, toothpaste, film, etc.) or quasi-drugs (gargle and mouthwash) to alleviate or treat the symptoms of gingivitis or periodontitis during the study
• Voluntarily signed the informed consent form
• Willing to participate in the study

Exclusion Criteria:

• Hypersensitivity to ingredients of investigational products
• Hypersensitivity to Azo dyes, acetylsalicylic acid or other prostaglandin synthase inhibitors

• Following diseases or state in the mouth:

  1. rampant caries or decayed tooth/teeth remained untreated for a long time
  2. multiple restorations which may be related to periodontal inflammation
  3. poor oral hygiene with heavy plaque or calculus deposition
  4. soft or hard tissue tumor
  5. systemic chronic diseases with oral manifestations
  6. fibrotic gingival enlargement
• Use of orthodontic appliances or removable partial denture(s)
• Having teeth or state in need of immediate treatment such as periodontal abscess, a tooth indicated for extraction, etc.
• History of aggressive periodontitis or acute necrotizing ulcerative gingivitis
• Received dental treatments such as endodontic treatments or periodontal therapy (including both nonsurgical and surgical therapy) within 3 months from randomization

• Received the following drugs for more than 2 weeks within 3 months from randomization:

  1. systemic/local antibiotics in the mouth or non-steroidal anti-inflammatory drugs
  2. cyclosporine or corticosteroids
  3. phenytoin, calcium antagonists, anticoagulants or antiplatelets
• Initiated drugs in treatment of chronic diseases within 3 months from randomization
• Received the same drug with investigational products within 3 months from randomization
• Medical conditions or diseases affecting the efficacy and safety of investigational products at the investigator's discretion
• Heavy smoker (20 cigarettes or more a day)
• Pregnant or breast-feeding
• Plans to have a child or unwilling to comply with using medically accepted contraception methods during the study
• Alcohol or drug abuse
• Other investigational products or procedures within 3 months from screening
• Not eligible due to other reasons at the investigator's discretion

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DKF-306; During Weeks 1 to 4, 2 tablets, t.i.d. During Weeks 5 to 12, 1 tablet, t.i.d.	Drug: DKF-306; Active ingredients
Placebo Comparator: Placebo; During Weeks 1 to 4, 2 tablets, t.i.d. During Weeks 5 to 12, 1 tablet, t.i.d.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in gingival index from baseline to Week 12	Weeks 0 and 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in plaque index from baseline to Weeks 4, 8 and 12	Weeks 0, 4, 8 and 12
Change in probing pocket depth from baseline to Weeks 4, 8 and 12	Weeks 0, 4, 8 and 12
Change in clinical attachment level from baseline to Weeks 4, 8 and 12	Weeks 0, 4, 8 and 12
Change in bleeding on probing (%) from baseline to Weeks 4, 8 and 12	Weeks 0, 4, 8 and 12
Change in gingival index from baseline to Weeks 4 and 8	Weeks 0, 4 and 8

Collaborators and Investigators

• Sponsor: Dongkook Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 27, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: DKF-306-P4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No