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

NCT04826926 | Completed

• 1 other identifier: UTurin02
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  [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.

  [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.

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

• Monetary cost for the treatment plan in €

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

Study Arms (1)

Non-surgical periodontal treatment NSPT

EXPERIMENTAL

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

Interventions

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.

Non-surgical periodontal treatment NSPT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

CIR Dental School

Turin, 10126, Italy

Location

Related Publications (3)

• Baima G, Dabdoub S, Thumbigere-Math V, Ribaldone DG, Caviglia GP, Tenori L, Fantato L, Vignoli A, Romandini M, Ferrocino I, Aimetti M. Multi-Omics Signatures of Periodontitis and Periodontal Therapy on the Oral and Gut Microbiome. J Periodontal Res. 2025 Nov 27. doi: 10.1111/jre.70055. Online ahead of print.

  PMID: 41307322 DERIVED

• Baima G, Ferrocino I, Del Lupo V, Colonna E, Thumbigere-Math V, Caviglia GP, Franciosa I, Mariani GM, Romandini M, Ribaldone DG, Romano F, Aimetti M. Effect of Periodontitis and Periodontal Therapy on Oral and Gut Microbiota. J Dent Res. 2024 Apr;103(4):359-368. doi: 10.1177/00220345231222800. Epub 2024 Feb 16.

  PMID: 38362600 DERIVED

• Ferrarotti F, Baima G, Rendinelli M, Citterio F, Mariani GM, Mussano F, Romano F, Romandini M, Aimetti M. Pocket closure after repeated subgingival instrumentation: a stress test to the EFP guideline for stage III-IV periodontitis. Clin Oral Investig. 2023 Nov;27(11):6701-6708. doi: 10.1007/s00784-023-05279-6. Epub 2023 Sep 29.

  PMID: 37773418 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 1, 2021
• Study Start: April 1, 2021
• Primary Completion: October 15, 2021
• Study Completion: January 10, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-01

Locations

IT (1)