Acne VulgarisNCT06237387
Association of Acne Vulgaris With Oral Hygiene and Gingivitis
An observational study of Acne Vulgaris and Gingivitis, run by Erzincan University.
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… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris, Gingivitis, Dental Plaque
- What is being tested?
- Periodontal examination
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2024to 15 Jul 2024
- Phase
- Observational
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants in puberty between the ages of 13-18.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Smoking
- Using antibiotics and anti-inflammatory drugs
- Having significant psychological problems
- Mouth breathing
About this study
Official title: 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?
Read more
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)
- Conditions
- Acne Vulgaris, Gingivitis, Dental Plaque, Oral Hygiene, Puberty
- Being tested
- Periodontal examination
- Medical subject headings
- Acne Vulgaris, Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal examinationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients with Allen-Smith acne score 0 and 2 (Mild lesions) Receives: Other: Periodontal examination | |
| Group B | Patients with Allen-Smith acne score 4 (Moderate lesions) Receives: Other: Periodontal examination | |
| Group C | Patients with Allen-Smith acne score 6 and 8 (Severe lesions) Receives: Other: Periodontal examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (3)
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
Measured: At the end of 1.5 months from the beginning
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.
Measured: At the end of 1.5 months from the beginning
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.
Measured: At the end of 1.5 months from the beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start5 Jun 2024 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk Okumuş, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237387
- Sponsor's protocol ID
- EUDF-OKUMUS-003
- Status last verified
- May 2024
- First submitted
- 24 Jan 2024
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Okumus OF, Yazici M, Kantarci A. Gingival inflammation and plaque accumulation affect therapeutic outcomes in patients with acne vulgaris. J Periodontol. 2026 Apr 18. doi: 10.1002/jper.70137. Online ahead of print.
PubMed 42001254
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Acne Vulgaris With Oral Hygiene and Severity of Plaque-Induced Gingivitis in Puberty
- ClinicalTrials.gov ID
- NCT06237387
- Acronym / sponsor ID
- EUDF-OKUMUS-003
- Conditions
- Acne Vulgaris, Gingivitis, Dental Plaque, Oral Hygiene, Puberty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 5 Jun 2024 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 1 Feb 2024 (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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Periodontal examinationPatients with Allen-Smith acne score 0 and 2 (Mild lesions) |
| Group B | – | Other: Periodontal examinationPatients with Allen-Smith acne score 4 (Moderate lesions) |
| Group C | – | Other: Periodontal examinationPatients with Allen-Smith acne score 6 and 8 (Severe lesions) |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants in puberty between the ages of 13-18.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- Smoking
- Using antibiotics and anti-inflammatory drugs
- Having significant psychological problems
- Mouth breathing
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 |
|---|---|---|
| Periodontal examinationDetermining 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. | Other | Group A, Group B, Group C |
Primary outcome
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.
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.
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.
3 secondary outcomes
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 response to medical treatment and oral hygiene
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Derived from this study: PubMed 42001254Okumus OF, Yazici M, Kantarci A. Gingival inflammation and plaque accumulation affect therapeutic outcomes in patients with acne vulgaris. J Periodontol. 2026 Apr 18. doi: 10.1002/jper.70137. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris and Gingivitis, run by Erzincan University.
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 10 inclusion and 4 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 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between acne vulgaris and the severity of gingivitis depending on the amount of plaque (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06237387, which also lists 1 linked publication.
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 28 May 2024.