Skip to main content
OpenTrials
Completed

NCT Number: NCT04826926

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIR Dental School

Turin, 10126, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Procedure/Surgery: Non Surgical Periodontal Therapy

Procedure

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.

Primary outcomes

  1. Change in pocket closure % (0 - 100 % with higher percentage indicating better status)

    Time frame: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]

    Percentage of pockets ≥ 5 mm that converted to ≤4 mm at the completion of NSPT

Secondary outcomes

  1. Change in Full Mouth Plaque Score (FMPS%) (0 - 100 % with higher percentage indicating worse status)

    Time frame: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]

    Percentage of full mouth plaque score considering 6 sited for each tooth.

  2. Change in Probing Pocket Depth (PD) (0 - 15 mm with higher values indicating worse outcomes.

    Time frame: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]

    The distance between the cementoenamel junction (CEJ) and the base of the pocket.

  3. Change in Clinical Attachment Level (CAL) (0 - 15 mm with higher values indicating worse outcomes.

    Time frame: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]

    The sum of Probing pocket depth (PD, mm) and Recession (Rec, mm)

  4. Monetary cost for the treatment plan in €

    Time frame: [Time Frame: 1 month, 3 months and 6 months after the completion of the therapy.]

    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.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 1, 2021
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.