Non-surgical Periodontal Therapy: Efficacy of re Treatment for Non-responding Sites. (Nrs_1)

March 16, 2022 updated by: Nicola Discepoli, University of Siena

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completition, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 16, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Nrs_1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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