Periodontal DiseasesNCT03265821
Influence of Smoking on Periodontal Healing One Year After Active Treatment
An observational study of Periodontal Diseases and Smoking, run by Dalarna County Council, Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Smoking
- What is being tested?
- Healing after treatment
- Type of treatment
- Surgery or procedure
- How many people
- 4,227 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- Individuals referred to a specialist clinic for periodontal treatment
Who cannot join
- edentulous individuals
About this study
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.
- Conditions
- Periodontal Diseases, Smoking
- Being tested
- Healing after treatment
- Keywords
- Smoking, Periodontal treatment, Periodontal disease, Healing
- Medical subject headings
- Periodontal Diseases, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healing after treatmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
Probing pocket depth
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalarna County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Edman, Dalarna County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265821
- Sponsor's protocol ID
- Smoking periodontal healing
- Status last verified
- Jun 2023
- First submitted
- 28 Aug 2017
- Last updated
- 29 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Smoking on Periodontal Healing One Year After Active Treatment
- ClinicalTrials.gov ID
- NCT03265821
- Acronym / sponsor ID
- Smoking periodontal healing
- Conditions
- Periodontal Diseases, Smoking
- Keywords
- Smoking, Periodontal treatment, Periodontal disease, Healing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,227 participants (actual)
- Lead sponsor
- Dalarna County Council, SwedenUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- Individuals referred to a specialist clinic for periodontal treatment
Key exclusion criteria (1 listed)
- edentulous individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healing after treatment | Procedure or surgery | – |
Primary outcome
Probing pocket depth
Time frame: 1 year
Probing pocket depth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Smoking, run by Dalarna County Council, Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.