Timing of Re-evaluation After Steps I-II of Periodontal Therapy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Repeated subgingival instrumentation 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
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.
|
| Active Comparator: Supragingival instrumentation 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
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Periodontitis stage III-IV
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Full-mouth plaque score (FMPS) < 25% at the 1-month re-evaluation
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Full-mouth bleeding score (FMBS) < 25% at the 1-month re-evaluation
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Signed informed consent
Exclusion criteria:
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Age < 18 yo
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Pregnancy or lactation
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Heavy smokers (>10 die)
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Conditions or diseases influencing periodontal healing
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Patients that cannot complete the 6 months follow-up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CIR Dental School | Turin | Italy | 10126 |
Sponsors and Collaborators
- University of Turin, Italy
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UTurin3