Back to resultsTiming of Periodontal Re-evaluation After Non-surgical Periodontal Therapy
Primary Purpose
Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Procedure/Surgery: Non Surgical Periodontal Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
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
Sites / Locations
- CIR Dental School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Non-surgical periodontal treatment NSPT
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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)
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.
Full Information
NCT ID
NCT04826926
First Posted
March 23, 2021
Last Updated
February 11, 2022
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT04826926
Brief Title
Timing of Periodontal Re-evaluation After Non-surgical Periodontal Therapy
Official Title
Impact of Timing of Re-evaluation After Non-surgical Periodontal Therapy on Clinical Parameters and Decision-making. A Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
January 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Turin, Italy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-surgical periodontal treatment NSPT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Procedure/Surgery: Non Surgical Periodontal Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pocket closure % (0 - 100 % with higher percentage indicating better status)
Description
Percentage of pockets ≥ 5 mm that converted to ≤4 mm at the completion of NSPT
Time Frame
[Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
Secondary Outcome Measure Information:
Title
Change in Full Mouth Plaque Score (FMPS%) (0 - 100 % with higher percentage indicating worse status)
Description
Percentage of full mouth plaque score considering 6 sited for each tooth.
Time Frame
[Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
Title
Change in Probing Pocket Depth (PD) (0 - 15 mm with higher values indicating worse outcomes.
Description
The distance between the cementoenamel junction (CEJ) and the base of the pocket.
Time Frame
[Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
Title
Change in Clinical Attachment Level (CAL) (0 - 15 mm with higher values indicating worse outcomes.
Description
The sum of Probing pocket depth (PD, mm) and Recession (Rec, mm)
Time Frame
[Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
Title
Monetary cost for the treatment plan in €
Description
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
[Time Frame: 1 month, 3 months and 6 months after the completion of the therapy.]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CIR Dental School
City
Turin
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Timing of Periodontal Re-evaluation After Non-surgical Periodontal Therapy
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