Timing of Re-evaluation After Steps I-II of Periodontal Therapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Repeated subgingival instrumentation; Procedure: Supragingival scaling

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Aimetti, Professor; Phone Number: 00390116331541; Email: mario.aimetti@unito.it

Study Locations

• Italy
  • Turin, Italy, 10126
    • Recruiting
    • CIR Dental School
    • Contact: Mario Aimetti, Prof.; Phone Number: +39116331541; Email: mario.aimetti@unito.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2023
• Primary Completion (Estimated): June 11, 2024
• Study Completion (Estimated): December 11, 2024

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: UTurin3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No