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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04826926
• Other study ID #: UTurin02
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: January 10, 2022

Study information

• Verified date: January 2022
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 10, 2022
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Italy	CIR Dental School	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.]
Secondary	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.]
Secondary	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.]
Secondary	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.]