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

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05188924
• Other study ID #: DKF-306-P4
• Status: Recruiting
• Phase: Phase 4
• Start date: May 22, 2020
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: Dongkook Pharmaceutical Co., Ltd.
• Contact: Young-Sung Kim
• Phone: +82-2-3010-5987
• Email: dumber73[@]mail.ulsan.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Drug:
• DKF-306
Active ingredients
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Youngsung	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dongkook Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in gingival index from baseline to Week 12		Weeks 0 and 12
Secondary	Change in plaque index from baseline to Weeks 4, 8 and 12		Weeks 0, 4, 8 and 12
Secondary	Change in probing pocket depth from baseline to Weeks 4, 8 and 12		Weeks 0, 4, 8 and 12
Secondary	Change in clinical attachment level from baseline to Weeks 4, 8 and 12		Weeks 0, 4, 8 and 12
Secondary	Change in bleeding on probing (%) from baseline to Weeks 4, 8 and 12		Weeks 0, 4, 8 and 12
Secondary	Change in gingival index from baseline to Weeks 4 and 8		Weeks 0, 4 and 8