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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05892315
Other study ID # UTurin3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 11, 2023
Est. completion date December 11, 2024

Study information

Verified date January 2024
Source University of Turin, Italy
Contact Mario Aimetti, Professor
Phone 00390116331541
Email mario.aimetti@unito.it
Is FDA regulated No
Health authority
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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 11, 2024
Est. primary completion date June 11, 2024
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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

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 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 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.
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. 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). Baseline, 1 month, 3 months and 6 months after the completion of the therapy.
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