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 prospective clinical trial is to investigate the effect of re-evaluation timing at 1-3-6 months after NSPT in terms of pocket closure, PD reduction, comprehensive treatment plan, and costs for the patient.
Interventions
PROCEDUREProcedure/Surgery: Non Surgical Periodontal Therapy
Conventional staging debridement (CSD) according to the severity of periodontal disease in 2 to 4 appointments at day 0, 7, 14 and 21. Supra and subgingival scaling and polishing will be performed by the use of manual and ultrasonic instruments and oral hygiene instructions will be given. 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
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 pocket closure % (0 - 100 % with higher percentage indicating better status) | [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.] | Percentage of pockets ≥ 5 mm that converted to ≤4 mm at the completion of NSPT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Full Mouth Plaque Score (FMPS%) (0 - 100 % with higher percentage indicating worse status) | [Time Frame: 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. | [Time Frame: 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. | [Time Frame: 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) |
| Monetary cost for the treatment plan in € | [Time Frame: 1 month, 3 months and 6 months after the completion of the therapy.] | Cost in € for the proposed treatment plan for patient at each re-evaluation timing based on the Italian Dental Association survey of charges for periodontal services for general dentists and periodontists. |
Countries
Italy
Outcome results
None listed