Using a special light device to improve periodontal treatment for smokers
Regular Home Use of Dual-light Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment in Smokers
This study is testing if using a special light device can help smokers with gum disease get better results from their periodontal treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Locations | 1 site (Thessaloníki) |
| Trial ID | NCT05962801 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of the Lumoral device, which utilizes dual-light photodynamic therapy, as an adjunct to non-surgical periodontal treatment in smokers with Stage III and Grade C periodontitis. Participants will be divided into two groups: one will use the Lumoral device nightly for 10 minutes before oral hygiene, while the other will follow standard oral hygiene without the device. Both groups will receive non-surgical periodontal treatment and will be monitored for 6 months to assess biofilm removal and host response. The study aims to determine if the Lumoral device enhances treatment outcomes compared to conventional methods alone.
Who should consider this trial
Good fit: Ideal candidates are smokers aged 35 and older with Stage III and Grade C periodontitis.
Not a fit: Patients who do not smoke or smoke fewer than 10 cigarettes per day may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved periodontal health and better treatment outcomes for smokers suffering from periodontitis.
How similar studies have performed: While the use of photodynamic therapy in periodontal treatment has been explored, this specific approach with the Lumoral device is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Periodontal disease Stage III and Grade C with at least 6 sites with probing depth (PD) and clinical attachment loss (CAL) ≥5 mm and bleeding on probing (BoP) ≥15 teeth * aged ≥35 * Smokers smoking ≥10 cigarettes per day Exclusion Criteria: * Patients allergic to indocyanine * Patients with active carious lesions * Need for prophylactic antimicrobial coverage * Scaling and root planing in the previous 6 months * Non-smoking status or smoking less than 10 cigarettes per day * Antimicrobial therapy in the previous 6 months * Immunomodifying conditions/ diseases (e.g. diabetes mellitus, rheumatoid arthritis, osteoporosis) * Long-term use of medication that could interfere with periodontal response (e.g. biphosphonates) * Pregnancy or lactation
Where this trial is running
Thessaloníki
- Dental School of Aristotle University of Thessaloniki — Thessaloníki, Greece (Recruiting)
Study contacts
- Study coordinator: Chrysoula Vakaki, Postgraduate
- Email: vakakichri@gmail.com
- Phone: 0030 6979766034
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.