Comparing Different Timings for Periodontal Re-evaluation After Non-surgical Periodontal Therapy (NSPT)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Parma
About this trial
This is a prospective cohort study that aims to describe the difference in terms of percentage of closed pockets (PPD \<5 mm and no BOP) when performing the periodontal re-evaluation at 3-4, 6-8 and 12 months.
Fifty-two, ≥18-year old, otherwise healthy, periodontitis patients will be recruited at Centro di Odontoiatria, Università di Parma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients affected by periodontitis
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-surgical periodontal therapy
Procedure/SurgeryNSPT will be performed following the principles of minimally invasive non-surgical therapy (MINST) described by Nibali et al. (Nibali et al., 2015, Nibali et al., 2019)
Treatment groups
52 Participants
are divided into 1 treatment groupGroup A: Non-surgical periodontal therapy1 intervention
Trial outcomes
Primary outcomes
1
changes in percentage of closed pockets (PPD <5 mm and no BOP)
Time frame
From baseline to 3-4; 6-8 and 12 monthsSecondary outcomes
1
Changes in probing pocket depth (PPD), recession (REC) and clinical attachment level (CAL)
Time frame
From baseline to 3-4; 6-8 and 12 months2
Changes in the percentages of sites with PPD reduction ≥2mm
Time frame
From baseline to 3-4; 6-8 and 12 months3
Changes in the percentages of sites with CAL gain ≥2mm
Time frame
From baseline to 3-4; 6-8 and 12 months4
Changes in the percentage of deep pockets (PPD≥6 mm)
Time frame
From baseline to 3-4; 6-8 and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov