Timing of Periodontal Re-evaluation After Non-surgical Periodontal Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Timing of Re-evaluation After Non-surgical Periodontal Therapy on Clinical Parameters and Decision-making. A Prospective Clinical Trial

Conditions
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Periodontitis

Intervention / Treatment
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* Procedure: Procedure/Surgery: Non Surgical Periodontal Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-surgical periodontal treatment NSPT<br>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. | Procedure: Procedure/Surgery: Non Surgical Periodontal Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pocket closure % (0 - 100 % with higher percentage indicating better status) | Percentage of pockets ≥ 5 mm that converted to ≤4 mm at the completion of NSPT | [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Full Mouth Plaque Score (FMPS%) (0 - 100 % with higher percentage indicating worse status) | Percentage of full mouth plaque score considering 6 sited for each tooth. | [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.] | 
| Change in Probing Pocket Depth (PD) (0 - 15 mm with higher values indicating worse outcomes. | The distance between the cementoenamel junction (CEJ) and the base of the pocket. | [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.] | 
| Change in Clinical Attachment Level (CAL) (0 - 15 mm with higher values indicating worse outcomes. | The sum of Probing pocket depth (PD, mm) and Recession (Rec, mm) | [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.] | 
| Monetary cost for the treatment plan in € | 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. | [Time Frame: 1 month, 3 months and 6 months after the completion of the therapy.] |