Clinical Relevance of Different Time of Periodontal Re-evaluation

NCT06086821 | Completed DMC

• 1 other identifier: PerioTiming-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of periodontitis follows an incremental step approach. The results after step 1 (Oral Hygiene Instruction and Professional Mechanical Plaque Removal) and 2 (subgingival instrumentation) are re-evaluated in order to understand whether the endpoints of therapy have been achieved. The case reevaluation may be performed at different time intervals, ranging from 2 weeks to 6 months. The aim of this study is to compare two different timing of re-evaluation, in terms of clinical indexes (PPD reduction; Pocket closure) and patients' morbidity (number of further therapies needed).

Conditions

Periodontal Diseases

Keywords

Periodontal Pocket; Periodontal treatment; Non-surgical periodontal treatment

Outcome Measures

Primary Outcomes (2)

• Number of Teeth not reaching EoT (Endpoint of treatment)

  Number of Teeth Needing further treatments

  3 months after step 2 of periodontal treatment is completed

• Number of Teeth not reaching EoT (Endpoint of treatment)

  Number of Teeth Needing further treatments

  6 months after step 2 of periodontal treatment is completed

Study Arms (2)

3-Months

ACTIVE COMPARATOR

Periodontal Re-evaluation performed three months after Step 2 have been completed.

Diagnostic Test: Periodontal Re-Evaluation

6-Months

EXPERIMENTAL

Periodontal Re-evaluation performed six months after Step 2 have been completed.

Diagnostic Test: Periodontal Re-Evaluation

Interventions

Periodontal Re-Evaluation DIAGNOSTIC_TEST

Recording of the periodontal charting

3-Months; 6-Months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with a diagnosis of Generalized, stage III or stage IV periodontitis;
• At least 20 teeth present
• At least eight teeth must show probing pocket depths (PPD) of ≥5mm and bleeding on probing (BOP). At least two of these teeth must have a PPD of ≥7 mm and at additional two teeth, the pockets must measure ≥6 mm;

You may not qualify if:

• Patients receiving periodontal treatment in the past 12 months;
• Patients receiving antibiotics in the past 3 months;
• Known medical conditions that affects the progression of periodontitis or that affect the outcomes of periodontal therapy;
• Compromised medical conditions requiring prophylactic antibiotic coverage; and ongoing drug therapy that might affect the clinical signs and symptoms of periodontitis.

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

Università degli Studi di Firenze

Florence, 50134, Italy

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Pocket

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor does not know when Step 1 and 2 of periodontal treatment have been performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: October 15, 2023
• Primary Completion: September 1, 2024
• Study Completion: February 1, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

IT (1)