Back to resultsTiming of Re-evaluation After Steps I-II of Periodontal Therapy
Primary Purpose
Periodontitis
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Repeated subgingival instrumentation
Supragingival scaling
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 SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Repeated subgingival instrumentation
Supragingival instrumentation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05892315
Brief Title
Timing of Re-evaluation After Steps I-II of Periodontal Therapy
Official Title
Timing of Re-evaluation After Steps I-II of Periodontal Therapy: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2023 (Actual)
Primary Completion Date
December 11, 2023 (Anticipated)
Study Completion Date
May 11, 2024 (Anticipated)
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 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.
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
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Repeated subgingival instrumentation
Arm Type
Experimental
Arm Description
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.
Arm Title
Supragingival instrumentation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Repeated subgingival instrumentation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Supragingival scaling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in treatment success % (0 - 100 % with higher percentage indicating better status)
Description
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
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
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
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
Baseline, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Aimetti, Professor
Phone
00390116331541
Email
mario.aimetti@unito.it
Facility Information:
Facility Name
CIR Dental School
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Aimetti, Prof.
Phone
+39116331541
Email
mario.aimetti@unito.it
12. IPD Sharing Statement
Learn more about this trial
Timing of Re-evaluation After Steps I-II of Periodontal Therapy
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