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The Impact of Cigarette Smoking on Periodontal Therapy

NCT ID: NCT05120206

Last Updated: 2021-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-01

Study Completion Date

2015-03-01

Brief Summary

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Periodontitis patients, 40 cigarette smokers and 40 non-smokers (defined by cotinine measures in serum), were recruited to this double arm prospective cohort study. Data were collected 3 months following non-surgical and surgical periodontal treatment, and following 12 months with supportive periodontal therapy. Data collected were clinical attachment level, probing depth, bleeding on probing,oral bacteria, serum, blood (PAXgeneBlood), and gingival crevicular fluid.

Detailed Description

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The overall aim of this work was to study clinical outcomes of active and supportive periodontal therapy in smokers and non-smokers with chronic periodontitis at patient, tooth, and site level. Moreover, to compare the periopathogenic microflora and inflammatory markers in gingival crevicular fluid and in blood in smokers and non-smokers following therapy.

Eighty patients, 40 smokers and 40 non-smokers, with moderate to severe chronic periodontitis were included in this prospective cohort study and treated non-surgically and surgically, and then followed-up in a supportive periodontal therapy program for 12 months. Smoking status was validated measuring serum cotinine levels at pre-treatment and 12 months following supportive periodontal therapy.

Clinical measurements included full mouth recordings of clinical attachment level, probing depth, bleeding on probing, and plaque index at pre-treatment and following active and supportive periodontal therapy. At the same timepoints, subgingival plaque samples of 20 subgingival periopathogenic bacterial species were analysed using checkerboard DNA-DNA hybridization. Blood samples (PAXgeneBlood), serum, gingval crevicular fluid were also collected at the three timepoints.

Conditions

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Periodontitis Cigarette Smoking

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective cohort study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cigarette smokers with periodontitis

Periodontal therapy in cigarette smokers

Group Type ACTIVE_COMPARATOR

Non-surgical periodontal therapy: motivation and instruction in oral hygiene, debridement using handinstrumentation (Hu-Firedy,Chicago, IL, USA;and American Eagle Instruments,Missoula, MT,USA).

Intervention Type PROCEDURE

Non-surgical and surgical periodontal therapy in cigarette smokers and non-smokers

Non-smokers with periodontitis

Periodontal therapy in non-smokers

Group Type ACTIVE_COMPARATOR

Non-surgical periodontal therapy: motivation and instruction in oral hygiene, debridement using handinstrumentation (Hu-Firedy,Chicago, IL, USA;and American Eagle Instruments,Missoula, MT,USA).

Intervention Type PROCEDURE

Non-surgical and surgical periodontal therapy in cigarette smokers and non-smokers

Interventions

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Non-surgical periodontal therapy: motivation and instruction in oral hygiene, debridement using handinstrumentation (Hu-Firedy,Chicago, IL, USA;and American Eagle Instruments,Missoula, MT,USA).

Non-surgical and surgical periodontal therapy in cigarette smokers and non-smokers

Intervention Type PROCEDURE

Other Intervention Names

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Periodontal surgery: periodontal flap and gingivectomy with postoperative rinse with 0.2% chlorhexidine gluconate (Corsodyl, GlaxoSmithKline, London, UK).

Eligibility Criteria

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Inclusion Criteria

* healthy subjects
* age 35-75 years
* diagnosed with chronic periodontitis
* at least four non-adjacent teeth with proximal sites with a PD ≥6 mm and clinical attachment loss ≥5 mm with BoP and no radiographic signs of apical pathology.
* either smokers (\>10 cigarettes per day for at least 5 years) or non-smokers (never smoked or not within the last 5 years).

Exclusion Criteria

* subjects who presented with any current medical condition or used medications known to affect periodontal healing
* incorrectly reported smoking status
* use of antibiotics within 6 months of the study
* received subgingival scaling within 6 months of the study
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dagmar F. Bunæs, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Dentistry - periodontics, University of Bergen, Norway

References

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Bunaes DF, Lie SA, Enersen M, Aastrom AN, Mustafa K, Leknes KN. Site-specific treatment outcome in smokers following non-surgical and surgical periodontal therapy. J Clin Periodontol. 2015 Oct;42(10):933-42. doi: 10.1111/jcpe.12462. Epub 2015 Oct 28.

Reference Type RESULT
PMID: 26407817 (View on PubMed)

Bunaes DF, Mustafa M, Mohamed HG, Lie SA, Leknes KN. The effect of smoking on inflammatory and bone remodeling markers in gingival crevicular fluid and subgingival microbiota following periodontal therapy. J Periodontal Res. 2017 Aug;52(4):713-724. doi: 10.1111/jre.12438. Epub 2017 Mar 17.

Reference Type RESULT
PMID: 28306142 (View on PubMed)

Other Identifiers

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94605

Identifier Type: -

Identifier Source: org_study_id