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

NCT ID: NCT05297227

Last Updated: 2022-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-02-01

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.

Conditions

Periodontal Therapy; Non Responding Sites

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Non surgical periodontal Therapy

Non-surgical periodontal therapy comprising oral hygiene instruction and motivation, professional mechanical plaque removal, and subgingival instrumentation will be performed. It consists in the use of an ultrasuond (piezoeletric device) and manual curettes.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Siena

OTHER

Sponsor Role: lead

Responsible Party

Nicola Discepoli

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Nicola Discepoli, Prof.

Role: CONTACT

nicola.discepoli2@unisi.it

3395256148

Other Identifiers

Nrs_1

Identifier Type: -

Identifier Source: org_study_id