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

NCT05297227 | Unknown

• 1 other identifier: Nrs_1
• Study Type: observational
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontal Therapy; Non Responding Sites

Outcome Measures

Primary Outcomes (1)

• Number of pocket closures

  Proportion of pathological periodontal pockets (non responding site) that will be closed (Ppd \<5 and bop-) after the second instrumentation

  through study completition, 6 months

Interventions

Non surgical periodontal Therapy PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with a Diagnosis of Periodontitis were recruited consecutively after a full mouth clinical examination and radiographic evaluation. The screening and periodontal chart were performed at the Department of Medical Biotechnologies, Unit of Periodontology, University Hospital of Siena, Siena (Italy).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Siena: lead

Central Study Contacts

Nicola Discepoli, Prof.

CONTACT

3395256148; nicola.discepoli2@unisi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 28, 2022
• Study Start: April 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: February 1, 2023
• Last Updated: March 28, 2022

Record last verified: 2022-03