Influence of Smoking on Periodontal Healing One Year Afte... | NCT03265821

Studies
Influence of Smoking on Periodontal Healing One Year After Active Treatment

NCT03265821

Sponsor

Dalarna County Council, Sweden

Status

Completed

Last Update Posted

Jun 29, 2023Actual

Enrollment

4,227Actual

Phase

Not provided

Conditions

Periodontal Diseases
Smoking

Interventions

Healing after treatment

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

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015Actual

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Aug 28, 2017

First Submission Date that Met QC Criteria

Aug 28, 2017

First Posted Date

Aug 29, 2017Actual

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

Jun 27, 2023

Last Update Posted Date

Jun 29, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kristina Edman, Reg dental hygienist, medical doctor, Dalarna County Council, SwedenPrincipal Investigator

Lead Sponsor

Dalarna County Council, SwedenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 aim of this study was to investigate whether cigarette smoking had any impact on the clinical outcomes 1 year after active periodontal treatment. Eligible for the study were 5680 individuals 20-85 years, referred to the specialised clinic for periodontal treatment at Gävle County Hospital between the years of 1980 and 2015. Before examination, all individuals filled in a questionnaire regarding their medical health, medication and smoking habits.

Excluded were edentulous individuals and where clinical data 1-year after active treatment, or smoking habits were missing (n=1453). Complete data for analyses was available for 4227 individuals.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,227Actual

Name	Type	Description	Arm Group Labels	Other Names
Healing after treatment	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Probing pocket depth	Probing pocket depth	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Individuals referred to a specialist clinic for periodontal treatment

Exclusion Criteria:

edentulous individuals

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Individuals 20-85 years, referred to the specialised clinic for periodontal treatment at Gavle County Hospital, Sweden between the years of 1980 and 2015.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D010510	Periodontal Diseases
D012907	Smoking

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided