Non-surgical Periodontal Therapy: Efficacy of re Treatment for Non-responding Sites.

• Conditions: Non Responding Sites; Periodontal Therapy

• Registration Number: NCT05297227
• Lead Sponsor: University of Siena

Brief Summary

The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. They were treated with PMPR and Subgingival Instrumentation according to their diagnosis. After 3 months they will be re-evaluated, and non-responding sites (Ppd\>=4mm and bop+) will be scheduled for the second session of PMPR and SI. After 2 months they will be re-evaluated and clinical efficacy will be defined.

Detailed Description

The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. Once included, individuals will receive, by a calibrated examiner, a full-mouth periodontal chart, and accordingly, they will be treated in a multi-step approach, in accordance with the recent clinical guidelines. The treatment will consist of oral hygiene instruction and motivation, risk factor control, professional mechanical plaque removal (PMPR), and subgingival instrumentation (SI): it will be performed by two experienced operators. Thereafter, after 3 months, patients will be evaluated and a new periodontal chart will be performed. The presence of non-responding sites (Ppd\>4 and bop+) will be treated with the second session of PMPR plus Subgingival Instrumentation. After 2 months patients will be clinically evaluated and a full periodontal chart will be completed.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-16
• Last Update Submitted: 2022-03-16
• Study First Posted: 2022-03-28
• Last Update Posted: 2022-03-28
• Study Start: 2022-04-01
• Primary Completion: 2022-11-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• unremarkable general health; age 18-80; minimum of 20 teeth; Periodontitis (Stage 1-4); no antibiotic intake in the previous 6 months;

Exclusion Criteria

• Subgingival instrumentation in the previous 12 months
• No antibiotic intake in the previous 3 months
• A compromised medical condition requiring prophylactic antibiotic coverage
• Pregnant/nursing
• Ongoing drug therapy that might alter the clinical signs and symptoms of periodontitis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of pocket closures	through study completition, 6 months	Proportion of pathological periodontal pockets (non responding site) that will be closed (Ppd \<5 and bop-) after the second instrumentation