Status:
UNKNOWN
Efficacy and Safety of DKF-306 in Patients With Periodontal Diseases
Lead Sponsor:
Dongkook Pharmaceutical Co., Ltd.
Conditions:
Periodontal Diseases
Eligibility:
All Genders
19-90 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
- cyclosporine or corticosteroids
- 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
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT05188924
Start Date
May 22 2020
End Date
December 1 2022
Last Update
January 12 2022
Active Locations (1)
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1
Youngsung
Seoul, South Korea