Timing of Re-evaluation After Steps I-II of 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 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.

Official Title
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Timing of Re-evaluation After Steps I-II of Periodontal Therapy: a Randomized Clinical Trial

Conditions
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Periodontitis

Intervention / Treatment
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* Procedure: Repeated subgingival instrumentation
* Procedure: Supragingival scaling


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Repeated subgingival instrumentation<br>Conventional staged debridement (CSD) according to the severity of periodontitis in 2 to 4 appointments at day 0, 7, 14 and 21. Re-instrumentation at 6 weeks and 3 months after completion of step I-II. | Procedure: Repeated subgingival instrumentation<br>* 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.<br>|
| Active Comparator: Supragingival instrumentation<br>Conventional staged debridement (CSD) according to the severity of periodontitis in 2 to 4 appointments at day 0, 7, 14 and 21. Only supragingival instrumentation at 6 weeks and 3 months after completion of step I-II. | Procedure: Supragingival scaling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in treatment success % (0 - 100 % with higher percentage indicating better status) | 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 | 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. | 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. | 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). | Baseline, 1 month, 3 months and 6 months after the completion of the therapy. |