Comparing two surgical techniques for treating gum disease
A "Closed" Surgical Technique for the Treatment of Residual Periodontal Pockets vs Access Flap Utilizing Papilla Preservation Techniques. A Randomized Controlled Trial
This study is testing a new type of gum surgery to see if it works better than the traditional method for treating gum disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Thessaloniki) |
| Trial ID | NCT05754307 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a new closed surgical technique (CST) against traditional papilla preservation techniques for treating isolated interdental periodontal defects. The CST aims to retain the soft-tissue architecture without the need for sutures, while the control group will undergo the access flap procedure. Participants will be monitored over a six-month period to assess clinical attachment levels, bone apposition, and inflammatory markers. The study involves a randomized controlled design to ensure robust results.
Who should consider this trial
Good fit: Ideal candidates are systematically healthy individuals with specific periodontal conditions who have completed initial non-surgical treatment.
Not a fit: Patients with untreated active periodontal inflammation or those with poorly controlled systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and faster recovery for patients with periodontitis.
How similar studies have performed: While the closed surgical technique is a novel approach, similar studies have shown promise in improving periodontal treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Systematically healthy subjects, not having consumed antibiotics 3 months before surgical periodontal treatment (baseline) * Smokers \<5 cig/day, former smokers or no smokers * Periodontal patients fulfilling non surgical initial periodontal treatment at least 3 months before surgical periodontal treatment (baseline day) and presenting at least one residual pocket with PPD and CAL ≥6mm and bleeding on probing, located interproximally with intrerdental site ≥2mm. * Compliant patients presenting high standards of oral hygiene (full mouth Plaque Index \<20%) strictly susceptible in Supportive Periodontal Treatment Exclusion Criteria: * Untreated active periodontal inflammation * Poorly controlled systematic diseases * Disorders compromise wound healing * Bisphosphonate medications * Patients under radiotherapy or chemotherapy * Drug-indused gingival hyperplasia * Pregnancy or lactation * Poor compliance during steps 1 and 2 of cause-related periodontal treatment * Compromised oral hygiene (full mouth Plaque Index \>30%), circumferential bone defect or narrow intrerdental site ≤2mm.
Where this trial is running
Thessaloniki
- Dental School, Aristotle University, Dept of Preventive Dentistry, Periodontology and Implant Biology — Thessaloniki, Greece (Recruiting)
Study contacts
- Study coordinator: Danae Apatzidou, Associate Professor
- Email: perioapatzidou@yahoo.gr
- Phone: 6934770361
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.