Comparing timing for periodontal re-evaluation after non-surgical therapy
Comparing Different Timings for Periodontal Re-evaluation After Non-surgical Periodontal Therapy (NSPT)
This study is testing how different timing for check-ups after non-surgical treatment helps people with gum disease see improvements in their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Parma Academic / other |
| Locations | 1 site (Parma) |
| Trial ID | NCT05088746 on ClinicalTrials.gov |
What this trial studies
This prospective cohort study aims to evaluate the effectiveness of different re-evaluation timings (3-4, 6-8, and 12 months) after non-surgical periodontal therapy in patients with periodontitis. A total of 52 participants, aged 18 and older, will undergo a series of assessments including periodontal evaluations and treatments over a 15-month period. The study will follow the CONSORT guidelines and involve multiple visits to monitor the percentage of closed pockets, defined as pockets with probing depth less than 5 mm and no bleeding on probing.
Who should consider this trial
Good fit: Ideal candidates are systemically healthy adults aged 18 and older with clinical evidence of periodontitis.
Not a fit: Patients with serious medical conditions, recent antibiotic use, or those requiring prophylactic antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize the timing of periodontal re-evaluations, leading to improved patient outcomes in managing periodontitis.
How similar studies have performed: While similar studies have explored periodontal therapy timings, this specific approach to re-evaluation timing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Systemically healthy males and females ≥18 years old * Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained * Clinical evidence of periodontitis, defined as the presence of interdental clinical attachment loss detectable at ≥2 non-adjacent teeth or buccal or oral clinical attachment loss ≥3mm with pocketing \>3 mm detectable at ≥2 teeth (Tonetti et al., 2018) * Not having received subgingival instrumentation within the previous 12 months Exclusion Criteria: * Medical history that includes serious medical conditions or transmittable diseases (e.g. serious cardiovascular disease, organ transplant, renal failure, AIDS, viral etc.). * Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam. * In treatment with drugs that induce gingival overgrowth * History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures * History of alcohol or drug abuse. * Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing, which can affect interpretation of study results). * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
Where this trial is running
Parma
- Centro Universitario di Odontoiatria — Parma, Italy (Recruiting)
Study contacts
- Study coordinator: Elena Calciolari, DDS, MS, PhD
- Email: elena.calciolari@unipr.it
- Phone: 0521 033640
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.