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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06237387
Other study ID # EUDF-OKUMUS-003
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 5, 2024
Est. completion date July 15, 2024

Study information

Verified date May 2024
Source Erzincan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date July 15, 2024
Est. primary completion date June 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Periodontal examination
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Erzincan University

Outcome

Type Measure Description Time frame Safety issue
Primary The relationship between acne vulgaris and the severity of gingivitis depending on the amount of plaque 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
Primary The relationship between acne vulgaris and oral hygiene 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
Primary Relationship between acne vulgaris and gingival index 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 The relationship between response to medical treatment and severity of gingivitis depending on the amount of plaque 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
Secondary The relationship between response to medical treatment and oral hygiene 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
Secondary The relationship between response to medical treatment and gingival index 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
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