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

Dongkook Pharmaceutical Co., Ltd.1 site in 1 country158 target enrollmentMay 22, 2020

ConditionsPeriodontal Diseases

InterventionsDKF-306 Placebo

DrugsDKF-306 Placebo

Overview

Phase: Phase 4
Intervention: DKF-306
Conditions: Periodontal Diseases
Sponsor: Dongkook Pharmaceutical Co., Ltd.
Enrollment: 158
Locations: 1
Primary Endpoint: Change in gingival index from baseline to Week 12
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 22, 2020

End Date

December 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dongkook Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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:
•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)

Arms & Interventions

DKF-306

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

Intervention: DKF-306

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Change in gingival index from baseline to Week 12

Time Frame: Weeks 0 and 12

Secondary Outcomes

Change in gingival index from baseline to Weeks 4 and 8(Weeks 0, 4 and 8)
Change in bleeding on probing (%) from baseline to Weeks 4, 8 and 12(Weeks 0, 4, 8 and 12)
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)