Periodontal DiseasesPhase 4NCT05188924
Efficacy and Safety of DKF-306 in Patients With Periodontal Diseases
A Phase 4 study testing DKF-306 in people with Periodontal Diseases, run by Dongkook Pharmaceutical Co., Ltd. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- DKF-306
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 May 2020to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Youngsung
Seoul
Young-Sung Kim, M.D., +82-2-3010-5987, dumber73@mail.ulsan.ac.kr
About this study
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
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
- Being tested
- DKF-306, Placebo
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKF-306Drug
Active ingredients
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| DKF-306 | Experimental | During Weeks 1 to 4, 2 tablets, t.i.d. During Weeks 5 to 12, 1 tablet, t.i.d. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival index from baseline to Week 12
Measured: Weeks 0 and 12
Secondary outcomes (5)
Change in plaque index from baseline to Weeks 4, 8 and 12
Measured: Weeks 0, 4, 8 and 12
Change in probing pocket depth from baseline to Weeks 4, 8 and 12
Measured: Weeks 0, 4, 8 and 12
Change in clinical attachment level from baseline to Weeks 4, 8 and 12
Measured: Weeks 0, 4, 8 and 12
Change in bleeding on probing (%) from baseline to Weeks 4, 8 and 12
Measured: Weeks 0, 4, 8 and 12
Change in gingival index from baseline to Weeks 4 and 8
Measured: Weeks 0, 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start22 May 2020
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongkook Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188924
- Sponsor's protocol ID
- DKF-306-P4
- Status last verified
- Dec 2021
- First submitted
- 27 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05188924
- Acronym / sponsor ID
- DKF-306-P4
- Conditions
- Periodontal Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Dongkook Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 May 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DKF-306 | Experimental | Drug: DKF-306During Weeks 1 to 4, 2 tablets, t.i.d. During Weeks 5 to 12, 1 tablet, t.i.d. |
| Placebo | Placebo comparator | Drug: PlaceboDuring Weeks 1 to 4, 2 tablets, t.i.d. During Weeks 5 to 12, 1 tablet, t.i.d. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (26 listed)
- Hypersensitivity to ingredients of investigational products
- Hypersensitivity to Azo dyes, acetylsalicylic acid or other prostaglandin synthase inhibitors
- Following diseases or state in the mouth:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DKF-306Active ingredients | Drug | DKF-306 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Change in gingival index from baseline to Week 12
Time frame: Weeks 0 and 12
5 secondary outcomes
Change in plaque index from baseline to Weeks 4, 8 and 12
Time frame: Weeks 0, 4, 8 and 12
Change in probing pocket depth from baseline to Weeks 4, 8 and 12
Time frame: Weeks 0, 4, 8 and 12
Change in clinical attachment level from baseline to Weeks 4, 8 and 12
Time frame: Weeks 0, 4, 8 and 12
Change in bleeding on probing (%) from baseline to Weeks 4, 8 and 12
Time frame: Weeks 0, 4, 8 and 12
Change in gingival index from baseline to Weeks 4 and 8
Time frame: Weeks 0, 4 and 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DKF-306 in people with Periodontal Diseases, run by Dongkook Pharmaceutical Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young-Sung Kim (+82-2-3010-5987, dumber73@mail.ulsan.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gingival index from baseline to Week 12 (time frame: Weeks 0 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022.