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

NCT05188924 | Unknown Phase 4

• 1 other identifier: DKF-306-P4
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

• Change in gingival index from baseline to Week 12

  Weeks 0 and 12

Secondary Outcomes (5)

• 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

Study Arms (2)

DKF-306

EXPERIMENTAL

During Weeks 1 to 4, 2 tablets, t.i.d. During Weeks 5 to 12, 1 tablet, t.i.d.

Drug: DKF-306

Placebo

PLACEBO COMPARATOR

During Weeks 1 to 4, 2 tablets, t.i.d. During Weeks 5 to 12, 1 tablet, t.i.d.

Drug: Placebo

Interventions

DKF-306 DRUG

Active ingredients

DKF-306

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hypersensitivity to ingredients of investigational products
• Hypersensitivity to Azo dyes, acetylsalicylic acid or other prostaglandin synthase inhibitors
• Following diseases or state in the mouth:
• rampant caries or decayed tooth/teeth remained untreated for a long time
• multiple restorations which may be related to periodontal inflammation
• poor oral hygiene with heavy plaque or calculus deposition
• soft or hard tissue tumor
• systemic chronic diseases with oral manifestations
• 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:
• systemic/local antibiotics in the mouth or non-steroidal anti-inflammatory drugs

Sponsors & Collaborators

• Dongkook Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Youngsung

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Young-Sung Kim

CONTACT

+82-2-3010-5987; dumber73@mail.ulsan.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 12, 2022
• Study Start: May 22, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 12, 2022

Record last verified: 2021-12

Locations

KR (1)