NCT07279896

Brief Summary

This study looked at whether a type of gum disease called Stage III periodontitis and cigarette smoking are linked to higher levels of "oxidative stress." Oxidative stress can damage DNA and RNA, which are important parts of our cells. Two markers in saliva-8-OHdG (a sign of DNA damage) and 8-OHG (a sign of RNA damage)-were measured to understand this. Researchers included four groups of adults: smokers with periodontitis, non-smokers with periodontitis, healthy smokers, and healthy non-smokers. All participants had a dental exam, which checked things like gum inflammation, bleeding, and pocket depth. After the exam, an unstimulated saliva sample was collected from each person. The samples were tested in a laboratory using a sensitive method that measures oxidative damage. The study found that people with periodontitis had higher levels of DNA and RNA damage in their saliva than healthy people. The highest levels were seen in smokers with periodontitis. Even healthy smokers showed higher levels of oxidative stress than healthy non-smokers. In general, worse gum disease was linked to higher levels of oxidative damage. These results suggest that saliva tests for 8-OHdG and 8-OHG may help identify gum disease in a simple, non-invasive way. The findings also show that smoking adds to the body's oxidative stress, especially when gum disease is present. The study provides new information about how smoking and gum disease together may affect cell health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 1, 2025

Last Update Submit

December 1, 2025

Conditions

Keywords

Periodontitis; Smoking; Oxidative Stress; 8-OHdG; 8-OHG; Saliva; Biomarkers

Outcome Measures

Primary Outcomes (1)

  • Salivary oxidative DNA and RNA damage (8-OHdG and 8-OHG levels)

    Concentrations of 8-hydroxy-2'-deoxyguanosine (8-OHdG) and 8-hydroxyguanosine (8-OHG) measured in unstimulated whole saliva using a high-sensitivity competitive ELISA kit. Saliva samples are collected at a separate baseline visit within the study period, after full-mouth periodontal examination and before any periodontal therapy. Biomarker levels (ng/mL) were compared across the four study groups and analyzed in relation to clinical periodontal parameters. Higher values indicate greater oxidative nucleic acid damage.

    Baseline (periodontal examination visit and saliva collection visit, before any periodontal treatment)

Study Arms (4)

Periodontitis Smoker

Participants diagnosed with Stage III periodontitis who are current cigarette smokers. No intervention was applied; biological samples (unstimulated saliva) were collected for biomarker analysis.

Periodontitis Non-Smoker

Participants diagnosed with Stage III periodontitis who do not smoke. No intervention was applied; unstimulated saliva samples were collected for laboratory analysis.

Healthy Smoker

Periodontally healthy individuals who are current smokers. No treatment or intervention was performed; only saliva samples and periodontal measurements were obtained.

Healthy Non-Smoker

Periodontally healthy non-smokers. No intervention was provided; participants underwent periodontal evaluation and saliva sample collection.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of systemically healthy adults aged 18-65 years, including individuals with Stage III periodontitis and periodontally healthy controls. Participants were categorized into four groups based on periodontal status and smoking habits: smokers and non-smokers with Stage III periodontitis, and smokers and non-smokers who were periodontally healthy.

You may qualify if:

  • Individuals aged 18 years or older
  • Having at least 16 permanent teeth, excluding third molars
  • Not using orthodontic appliances
  • Not pregnant or breastfeeding
  • Systemically healthy individuals with no systemic diseases that could affect periodontal status
  • No use of anti-inflammatory or antimicrobial medications within the last 6 months
  • No periodontal treatment within the last 12 months

You may not qualify if:

  • Pregnant or breastfeeding individuals.
  • Use of anti-inflammatory or antimicrobial drugs in the past 6 months.
  • Use of antioxidant supplements in the past 3 months.
  • Periodontal treatment within the past 12 months.
  • Diagnosis of psychiatric disorders.
  • Any oral infection.
  • Fewer than 16 permanent teeth (excluding third molars).
  • Alcohol dependence.
  • Active infectious diseases (Acute hepatitis, AIDS, tuberculosis), malignancy, or any systemic condition that may affect periodontal tissues.
  • Current use of medications known to affect periodontal tissues (phenytoin, cyclosporine A, calcium channel blockers).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Dentistry, Department of Periodontology

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

Location

Related Publications (3)

  • Hendek MK, Erdemir EO, Kisa U, Ozcan G. Effect of initial periodontal therapy on oxidative stress markers in gingival crevicular fluid, saliva, and serum in smokers and non-smokers with chronic periodontitis. J Periodontol. 2015 Feb;86(2):273-82. doi: 10.1902/jop.2014.140338. Epub 2014 Oct 17.

  • Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

  • Kurgan S, Onder C, Altingoz SM, Bagis N, Uyanik M, Serdar MA, Kantarci A. High sensitivity detection of salivary 8-hydroxy deoxyguanosine levels in patients with chronic periodontitis. J Periodontal Res. 2015 Dec;50(6):766-74. doi: 10.1111/jre.12263. Epub 2015 Feb 7.

Biospecimen

Retention: SAMPLES WITH DNA

Unstimulated whole saliva samples stored at -80°C. Saliva samples may contain cellular material and DNA.

MeSH Terms

Conditions

PeriodontitisSmoking

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBehavior

Study Officials

  • Sivge Kurgan

    Ankara University, Faculty of Dentistry, Department of Periodontology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Periodontology Specialist (Resident)

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 12, 2025

Study Start

May 5, 2025

Primary Completion

August 4, 2025

Study Completion

August 15, 2025

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to patient privacy concerns, data protection regulations, and the terms of the local ethics committee approval

Locations