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Clinical Trials/NCT05297227
NCT05297227
Unknown
Not Applicable

Non-surgical Periodontal Therapy: Efficacy of Repeated Subgingival Instrumentation for Non-responding Sites. A Quasi-experimental Study

University of Siena0 sites63 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontal Therapy
Sponsor
University of Siena
Enrollment
63
Primary Endpoint
Number of pocket closures
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
February 1, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nicola Discepoli

Associate Professor

University of Siena

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of pocket closures

Time Frame: 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

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