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The Impact of Cigarette Smoking on Periodontal Therapy

Sponsor
University of Bergen (Other)
Overall Status
Completed
CT.gov ID
NCT05120206
Collaborator
(none)
80
Enrollment
2
Arms
35
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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).
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective cohort studyProspective cohort study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Outcomes of Periodontal Therapy in Smokers and Non-smokers With Chronic Periodontitis
Actual Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

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).

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PD ≥5 mm with BoP [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 Outcome Measures

    1. Teeth present [24 months]

      Number of teeth

    2. Clinical periodontal attachmentloss [24 months]

      Clinical attachment loss in mm

    3. Periodontal pocket depth [24 months]

      Probing depth in mm

    4. Bleeding at site level [24 months]

      Bleeding on probing (yes or no)

    5. Bleeding at patient level [24 months]

      Bleeding index in percentage (%)

    6. Plaque at patient level [24 months]

      Plaque index in percentage (%)

    7. Amount of periopathogenic bacteria [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) [24 months]

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

    9. Serum proteins [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Bergen

    Investigators

    • Principal Investigator: Dagmar F. Bunæs, PhD, Department of Clinical Dentistry - periodontics, University of Bergen, Norway

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Bergen
    ClinicalTrials.gov Identifier:
    NCT05120206
    Other Study ID Numbers:
    • 94605
    First Posted:
    Nov 15, 2021
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Periodontitis
    Chlorhexidine
    Chlorhexidine gluconate

    Study Results

    No Results Posted as of Nov 15, 2021