Non-surgical Periodontal Therapy: Efficacy of re Treatmen... | NCT05297227

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

NCT05297227

Sponsor

University of Siena

Status

Unknown status

Last Update Posted

Mar 28, 2022Actual

Enrollment

63Estimated

Phase

Not provided

Conditions

Periodontal Therapy
Non Responding Sites

Interventions

Non surgical periodontal Therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Estimated

Primary Completion Date

Nov 1, 2022Estimated

Completion Date

Feb 1, 2023Estimated

First Submitted Date

Mar 16, 2022

First Submission Date that Met QC Criteria

Mar 16, 2022

First Posted Date

Mar 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2022

Last Update Posted Date

Mar 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

63Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

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).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nicola Discepoli, Prof.	Contact	3395256148		nicola.discepoli2@unisi.it

Overall Officials

Not provided

Locations

Not provided