Periodontitis
Conditions
Brief summary
Literature on non surgical periodontal therapy (NSPT) shows lack of clarity in reporting information on re-evaluation timing and clinical response. If the re-evaluation was done shortly after NSPT, this is also likely to have an influence on the surgical treatment plan. The aim of this randomized clinical trial is to investigate the effect of re-evaluation timing at 1-3-6 months after NSPT in terms of pocket closure, probing pocket depth reduction, comprehensive treatment plan, and costs for the patient.
Interventions
PROCEDURERepeated subgingival instrumentation
Supragingival scaling will be performed at sites with plaque and subgingival scaling will be performed by the use of manual and ultrasonic instruments at pockets ≥ 4 mm with bleeding. Oral hygiene instructions will be reinforced. Patients will be instructed to use interdental brushes with appropriate size interdental brushes or dental floss when interdental embrasures will not allow for interdental brushing.
PROCEDURESupragingival scaling
Supragingival scaling will be performed at sites with plaque. Oral hygiene instructions will be reinforced. Patients will be instructed to use interdental brushes with appropriate size interdental brushes or dental floss when interdental embrasures will not allow for interdental brushing.
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Periodontitis stage III-IV * Full-mouth plaque score (FMPS) \< 25% at the 1-month re-evaluation * Full-mouth bleeding score (FMBS) \< 25% at the 1-month re-evaluation * Signed informed consent
Exclusion criteria
* Age \< 18 yo * Pregnancy or lactation * Heavy smokers (\>10 die) * Conditions or diseases influencing periodontal healing * Patients that cannot complete the 6 months follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in treatment success % (0 - 100 % with higher percentage indicating better status) | Baseline, 1 month, 3 months and 6 months after the completion of the therapy. | Percentage of pockets ≥ 4 mm with bleeding that converted to ≤ 3 mm or ≤4 mm without bleeding at the completion of non-surgical periodontal therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Full Mouth Plaque Score (FMPS%) (0 - 100 % with higher percentage indicating worse status) | Baseline, 1 month, 3 months and 6 months after the completion of the therapy. | Percentage of full mouth plaque score considering 6 sited for each tooth. |
| Change in Probing Pocket Depth (PD) (0 - 15 mm with higher values indicating worse outcomes). | Baseline, 1 month, 3 months and 6 months after the completion of the therapy. | The distance between the cementoenamel junction (CEJ) and the base of the pocket. |
| Change in Clinical Attachment Level (CAL) (0 - 15 mm with higher values indicating worse outcomes). | Baseline, 1 month, 3 months and 6 months after the completion of the therapy. | The sum of Probing pocket depth (PD, mm) and Recession (Rec, mm). |
Countries
Italy
Contacts
Primary ContactMario Aimetti, Professor
Outcome results
None listed