- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06237387
Association of Acne Vulgaris With Oral Hygiene and Gingivitis
Association of Acne Vulgaris With Oral Hygiene and Severity of Plaque-Induced Gingivitis in Puberty
The goal of this observational study is to learn about in the relationship between acne vulgaris and oral hygiene and gingivitis. The main questions it aims to answer are:
- Is there a relationship between the severity of acne vulgaris lesions and the severity of plaque-related gingivitis?
- Could oral hygiene or the severity of plaque-related gingivitis have an impact on the treatment of acne lesions?
Participants will;
- First be examined at the dermatology clinic.
- Then be examined at the periodontology clinic.
- Participants with severe acne vulgaris lesions will be examined a second time at the dermatology clinic. (1.5 months after the first examination)
- Regularly use the antibiotic containing 100 mg doxycycline prescribed in the dermatology clinic for acne treatment. (Patients deemed suitable by the dermatologist)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being systemically healthy
- Not using any medication regularly
- Not having received acne treatment before
- Not having a known allergy to Doxycycline/Tetracycline antibiotics
- Not having received periodontal disease treatment in the last 6 months
- Not having taken antibiotics or anti-inflammatory drugs in the last month
- Not having used antiseptic mouthwash in the last month
- Being between the ages of 13-18
- No radiographic bone loss or clinical attachment loss
- Absence of any diagnosed psychiatric disease
Exclusion Criteria:
- Smoking
- Using antibiotics and anti-inflammatory drugs
- Having significant psychological problems
- Mouth breathing
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group A
Patients with Allen-Smith acne score 0 and 2 (Mild lesions)
|
Determining the patient's oral hygiene status and the severity of gingivitis.
For this purpose, the non-invasive Löe-Silness plaque and gingival index system will be used.
|
|
Group B
Patients with Allen-Smith acne score 4 (Moderate lesions)
|
Determining the patient's oral hygiene status and the severity of gingivitis.
For this purpose, the non-invasive Löe-Silness plaque and gingival index system will be used.
|
|
Group C
Patients with Allen-Smith acne score 6 and 8 (Severe lesions)
|
Determining the patient's oral hygiene status and the severity of gingivitis.
For this purpose, the non-invasive Löe-Silness plaque and gingival index system will be used.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The relationship between acne vulgaris and the severity of gingivitis depending on the amount of plaque
Time Frame: Baseline
|
Data from three groups will be presented as the correlation between the Gingival Index score and the Plaque Index score.
The relationship between the severity of gingival inflammation depending on the amount of plaque and acne lesions will be evaluated.
|
Baseline
|
|
The relationship between acne vulgaris and oral hygiene
Time Frame: Baseline
|
Describes the relationship between plaque index data obtained during periodontal examination of patients and acne lesions. According to the plaque index system, a score of "0" indicates the absence of plaque. A score of "1" refers to the amount of plaque that is not visible to the eye but detected by the periodontal probe. A score of "2" refers to the amount of plaque detectable visually. The highest score, "3", indicates excessive plaque accumulation. |
Baseline
|
|
Relationship between acne vulgaris and gingival index
Time Frame: Baseline
|
To compare gingival index values obtained during periodontal examination with acne vulgaris, regardless of plaque index values. According to the gingival index system, a score of "0" indicates completely healthy gums. A score of "1" indicates mild erythema and no bleeding on probing. A score of "2" indicates a small amount of bleeding on probing. The highest score, "3", indicates spontaneous or excessive gingival bleeding. |
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The relationship between response to medical treatment and severity of gingivitis depending on the amount of plaque
Time Frame: At the end of 1.5 months from the beginning
|
The relationship between the response to medical treatment at the end of 1.5 months from the beginning and the severity of gingivitis depending on the amount of plaque in Group C (severe periodontitis) patients
|
At the end of 1.5 months from the beginning
|
|
The relationship between response to medical treatment and oral hygiene
Time Frame: At the end of 1.5 months from the beginning
|
Response to medical treatment in Group C (severe periodontitis) patients at the end of 1.5 months from the beginning. The relationship between response to medical treatment and plaque index. According to the plaque index system, a score of "0" indicates the absence of plaque. A score of "1" refers to the amount of plaque that is not visible to the eye but detected by the periodontal probe. A score of "2" refers to the amount of plaque detectable visually. The highest score, "3", indicates excessive plaque accumulation. |
At the end of 1.5 months from the beginning
|
|
The relationship between response to medical treatment and gingival index
Time Frame: At the end of 1.5 months from the beginning
|
Response to medical treatment in Group C (severe periodontitis) patients after 1.5 months from the beginning. The relationship between response to medical treatment and gingival index. According to the gingival index system, a score of "0" indicates completely healthy gums. A score of "1" indicates mild erythema and no bleeding on probing. A score of "2" indicates a small amount of bleeding on probing. The highest score, "3", indicates spontaneous or excessive gingival bleeding. |
At the end of 1.5 months from the beginning
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EUDF-OKUMUS-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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