The Impact of Cigarette Smoking on Periodontal Therapy

Outcomes of Periodontal Therapy in Smokers and Non-smokers With Chronic Periodontitis

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis; Cigarette Smoking
• Intervention / Treatment: Procedure: 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).

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cigarette smokers with periodontitis; Periodontal therapy in cigarette smokers	Procedure: 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; Other Names: Periodontal surgery: periodontal flap and gingivectomy with postoperative rinse with 0.2% chlorhexidine gluconate (Corsodyl, GlaxoSmithKline, London, UK).
Active Comparator: Non-smokers with periodontitis; Periodontal therapy in non-smokers	Procedure: 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; Other Names: Periodontal surgery: periodontal flap and gingivectomy with postoperative rinse with 0.2% chlorhexidine gluconate (Corsodyl, GlaxoSmithKline, London, UK).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PD ≥5 mm with BoP	Corrected for clustering within patients, teeth, and sites over time, was the unit of the analysis and PD ≥5 mm with BoP was the outcome (dependent variable) dichotomized as present (1) or absent (0).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Teeth present	Number of teeth	24 months
Clinical periodontal attachmentloss	Clinical attachment loss in mm	24 months
Periodontal pocket depth	Probing depth in mm	24 months
Bleeding at site level	Bleeding on probing (yes or no)	24 months
Bleeding at patient level	Bleeding index in percentage (%)	24 months
Plaque at patient level	Plaque index in percentage (%)	24 months
Amount of periopathogenic bacteria	Subgingival plaque samples of 20 subgingival periopathogenic bacterial species were analysed using checkerboard DNA-DNA hybridization.	24 months
Inflammatory gingival crevicular fluid markers (proteins)	Concentrations of gingival crevicular fluid biomarkers measured in pg/mLwere analysed using multiplex and singleplex micro-bed immunoassays.	24 months
Serum proteins	Concentration of inflammatory serum markers measured in pg/ɥL determined using multiplex kit Bio-Plex Human ProTM Assay.	24 months
Gene expression in blood	Inflammatory gene (RNA) expression levels is estimated by counting the reads that map to genes or exones using the the RPKM (Reads per Kilobases per Million reads) methods.	24 months

Collaborators and Investigators

• Sponsor: University of Bergen
• Investigators: Principal Investigator: Dagmar F. Bunæs, PhD, Department of Clinical Dentistry - Periodontics, University of Bergen, NORWAY

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 94605

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No