NCT06237387

Brief 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)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

June 5, 2024

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

10 days

First QC Date

January 24, 2024

Last Update Submit

May 24, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • The relationship between response to medical treatment and severity of gingivitis depending on the amount of plaque

    At the end of 1.5 months from the beginning

  • The relationship between response to medical treatment and oral hygiene

    At the end of 1.5 months from the beginning

  • The relationship between response to medical treatment and gingival index

    At the end of 1.5 months from the beginning

Study Arms (3)

Group A

Patients with Allen-Smith acne score 0 and 2 (Mild lesions)

Other: Periodontal examination

Group B

Patients with Allen-Smith acne score 4 (Moderate lesions)

Other: Periodontal examination

Group C

Patients with Allen-Smith acne score 6 and 8 (Severe lesions)

Other: Periodontal examination

Interventions

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 AGroup BGroup C

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Participants in puberty between the ages of 13-18.

You may qualify if:

  • 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

You may not qualify if:

  • Smoking
  • Using antibiotics and anti-inflammatory drugs
  • Having significant psychological problems
  • Mouth breathing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acne VulgarisGingivitisDental Plaque

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesDental DepositsTooth Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 1, 2024

Study Start

June 5, 2024

Primary Completion

June 15, 2024

Study Completion

July 15, 2024

Last Updated

May 28, 2024

Record last verified: 2024-05