Exploring the link between apical periodontitis and diabetes through inflammatory markers
Association of Apical Periodontitis With Systemic Level of Inflammatory Markers : A Longitudinal Intervention Study
This study is testing how apical periodontitis might affect people with type 2 diabetes by looking at inflammation levels before and after root canal treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 30 Years to 55 Years |
| Sex | All |
| Sponsor | Postgraduate Institute of Dental Sciences Rohtak Academic / other |
| Locations | 1 site (Rohtak, Haryana) |
| Trial ID | NCT05814965 on ClinicalTrials.gov |
What this trial studies
This longitudinal interventional study aims to investigate the cause-and-effect relationship between apical periodontitis (AP) and type 2 diabetes mellitus (DM) by assessing systemic inflammatory markers. A total of 280 patients with radiographic evidence of AP will be recruited and divided into two groups: those with type 2 DM and those without systemic disease. Each group will further consist of patients with AP and matched controls. The study will evaluate periapical healing and changes in inflammatory markers following root canal treatment over a 12-month period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30-55 with at least 20 natural teeth and radiographic evidence of apical periodontitis.
Not a fit: Patients with moderate to severe periodontitis, immunosuppression, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the management of dental health in diabetic patients, potentially improving treatment outcomes.
How similar studies have performed: While there have been cross-sectional studies on this topic, this prospective interventional approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 30-55 year age group with minimum 20 natural teeth, with pulp necrosis confirmed by cold test and electric pulp test and radiographic evidence of periapical radiolucency with PAI score of ≥3 (24) or more in at least one mature tooth. * control in the systemically healthy group will be selected to match participants in terms of age, sex, and BMI. * control for participants with type 2 DM will be selected to additionally match with glycaemic control, drugs and dietary measures apart from other physical attributes. Exclusion Criteria: * Patients with clinical diagnosis of moderate to severe periodontitis (≥6 sites with probing depth ≥5 mm at separate teeth, with attachment loss and radiographic alveolar bone loss), Patients with immunosuppression, pregnancy, conditions requiring prophylactic antibiotics prior to dental treatment, bleeding disorders, medical conditions that may affect study participation (e.g., unstable cardiovascular disease) and chronic inflammatory conditions like rheumatoid
Where this trial is running
Rohtak, Haryana
- Pgids — Rohtak, Haryana, India (Recruiting)
Study contacts
- Principal investigator: Sanjay Tewari — Post Graduate Institute of Dental Sciences,rohtak
- Study coordinator: Sanjay Tewari, Mds
- Email: principalpgids@yahoo.in
- Phone: 01262-283876
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.