Comparing Different Timings for Periodontal Re-evaluation After Non-surgical Periodontal Therapy (NSPT)

NCT05088746 | Recruiting

• 1 other identifier: P-002
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective cohort study that aims to describe the difference in terms of percentage of closed pockets (PPD \<5 mm and no BOP) when performing the periodontal re-evaluation at 3-4, 6-8 and 12 months. Fifty-two, ≥18-year old, otherwise healthy, periodontitis patients will be recruited at Centro di Odontoiatria, Università di Parma.

Conditions

Periodontitis; Periodontal Pocket

Outcome Measures

Primary Outcomes (1)

• changes in percentage of closed pockets (PPD <5 mm and no BOP)

  From baseline to 3-4; 6-8 and 12 months

Secondary Outcomes (8)

• Changes in probing pocket depth (PPD), recession (REC) and clinical attachment level (CAL)

  From baseline to 3-4; 6-8 and 12 months

• Changes in the percentages of sites with PPD reduction ≥2mm

  From baseline to 3-4; 6-8 and 12 months

• Changes in the percentages of sites with CAL gain ≥2mm

  From baseline to 3-4; 6-8 and 12 months

• Changes in the percentage of deep pockets (PPD≥6 mm)

  From baseline to 3-4; 6-8 and 12 months

• Evaluation of global changes in quality of life

  4-6 weeks; 3-4 months; 6-8 months; 12 months

Study Arms (1)

Non-surgical periodontal therapy

Procedure: Non-surgical periodontal therapy

Interventions

Non-surgical periodontal therapy PROCEDURE

NSPT will be performed following the principles of minimally invasive non-surgical therapy (MINST) described by Nibali et al. (Nibali et al., 2015, Nibali et al., 2019)

Non-surgical periodontal therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by periodontitis

You may qualify if:

• Systemically healthy males and females ≥18 years old
• Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained
• Clinical evidence of periodontitis, defined as the presence of interdental clinical attachment loss detectable at ≥2 non-adjacent teeth or buccal or oral clinical attachment loss ≥3mm with pocketing \>3 mm detectable at ≥2 teeth (Tonetti et al., 2018)
• Not having received subgingival instrumentation within the previous 12 months

You may not qualify if:

• Medical history that includes serious medical conditions or transmittable diseases (e.g. serious cardiovascular disease, organ transplant, renal failure, AIDS, viral etc.).
• Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
• In treatment with drugs that induce gingival overgrowth
• History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
• History of alcohol or drug abuse.
• Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing, which can affect interpretation of study results).
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.

Sponsors & Collaborators

• University of Parma: lead

Study Sites (1)

Centro Universitario di Odontoiatria

Parma, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Non-stimulated saliva sample will be collected at certain visits (baseline, 3-4, 6-8 and 12 months post NSPT), and will be stored (frozen) for analysis. Samples of GCF will be collected from the deepest sites (maximum of 5) at baseline, 3-4, 6-8 and 12 months post NSPT. GCF will be collected prior to periodontal probing to avoid contamination by blood.

MeSH Terms

Conditions

Periodontitis; Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Elena Calciolari, DDS, MS, PhD

CONTACT

0521 033640; elena.calciolari@unipr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. DDS, MS., PhD

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: October 22, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)