Timing of Periodontal Re-evaluation After Non-surgical Periodontal Therapy

Impact of Timing of Re-evaluation After Non-surgical Periodontal Therapy on Clinical Parameters and Decision-making. A Prospective 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 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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Procedure/Surgery: Non Surgical Periodontal Therapy

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • CIR Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Non-surgical periodontal treatment NSPT; 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.

Procedure: Procedure/Surgery: Non Surgical Periodontal Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	[Time Frame: 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.	[Time Frame: 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.	[Time Frame: 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)	[Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
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.	[Time Frame: 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): April 1, 2021
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): January 10, 2022

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: UTurin02

Drug and device information, study documents

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