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Completed

NCT Number: NCT05120206

The Impact of Cigarette Smoking on Periodontal Therapy

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.

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Key information

Conditions

Periodontitis Behavior Cigarette Smoking Mouth Diseases Periodontal Diseases Smoking Stomatognathic Diseases Tobacco Smoking Tobacco Use

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Procedure

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).

Primary outcomes

  1. PD ≥5 mm with BoP

    Time frame: 24 months

    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).

Secondary outcomes

  1. Teeth present

    Time frame: 24 months

    Number of teeth

  2. Clinical periodontal attachmentloss

    Time frame: 24 months

    Clinical attachment loss in mm

  3. Periodontal pocket depth

    Time frame: 24 months

    Probing depth in mm

  4. Bleeding at site level

    Time frame: 24 months

    Bleeding on probing (yes or no)

  5. Bleeding at patient level

    Time frame: 24 months

    Bleeding index in percentage (%)

  6. Plaque at patient level

    Time frame: 24 months

    Plaque index in percentage (%)

  7. Amount of periopathogenic bacteria

    Time frame: 24 months

    Subgingival plaque samples of 20 subgingival periopathogenic bacterial species were analysed using checkerboard DNA-DNA hybridization.

  8. Inflammatory gingival crevicular fluid markers (proteins)

    Time frame: 24 months

    Concentrations of gingival crevicular fluid biomarkers measured in pg/mLwere analysed using multiplex and singleplex micro-bed immunoassays.

  9. Serum proteins

    Time frame: 24 months

    Concentration of inflammatory serum markers measured in pg/ɥL determined using multiplex kit Bio-Plex Human ProTM Assay.

  10. Gene expression in blood

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 15, 2021
Registry last updated
Nov 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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