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Periodontal Treatment in Non Smokers, Former Smokers and Smokers

Primary Purpose

Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mechanical plaque control
Sponsored by
University of Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring smoking, oral hygiene

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged of minimum 18 years old
  • chronic periodontitis
  • presence of a minimum of 6 teeth at each arch
  • a minimum of 6 teeth with pocket depth of 5 mm
  • signed the informed consent

Exclusion Criteria:

  • aggressive periodontitis
  • diabetes
  • connective tissue disease
  • pregnancy
  • radio-therapy
  • chemotherapy
  • psychological disease
  • previous periodontal therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    non smokers

    former smoker

    smoker

    Arm Description

    patient who never smoked

    patient who smoked in the past

    patient who still smoke

    Outcomes

    Primary Outcome Measures

    Change from baseline of probing depth (PD)
    PD was measured , in millimetern with periodontal probe, at 6 sites of each tooth

    Secondary Outcome Measures

    Change from baseline of BOP (bleeding on probing)
    BOP was measured , in percentage of bleeding, at 6 sites of each tooth

    Full Information

    First Posted
    August 14, 2019
    Last Updated
    August 20, 2019
    Sponsor
    University of Liege
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04061460
    Brief Title
    Periodontal Treatment in Non Smokers, Former Smokers and Smokers
    Official Title
    Respective Effects of Periodontal Oral Hygiene Instructions and Non-surgical Treatment on Clinical and Patient Related Outcomes: a Controlled Study in Non Smoker, Former Smoker and Smoker
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2014 (Actual)
    Primary Completion Date
    July 1, 2015 (Actual)
    Study Completion Date
    July 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Liege

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The present study was designed as a prospective controlled study focusing on the effect of oral hygiene instructions and periodontal nonsurgical treatment( PNST) on clinical outcomes and patients related outcomes (PROMs) in smokers versus former smokers versus non smoker patients.
    Detailed Description
    75 consecutive patients presenting chronic periodontitis and who needed periodontal treatment were recruited in the Department of Periodontology and Oral Surgery at the University Hospital of Liège, Belgium (CHU, Sart-Tilman) according to the inclusion criteria. The patients were subdivided between three groups: non-smoker (25), former smoker (25), and smoker patients(25). Patients received informations about periodontitis genesis, the demonstration of oral hygiene instructions (OHI), the goal of PNST and the follow-up time were given ( baseline, after OHI, 3 months after PNST). Periodontal clinical parameters and PROMS were collecetd and compared between 3 groups, at each visit. Data collection:Periodontal clinical measurements and PROMS The periodontal examination was conducted by a single periodontist (L.S) and included: probing depth (PD), gingival recession (RD), clinical attachment level (CAL), bleeding on probing (BOP), plaque score index (PI), Furcation (Furc), tooth mobility , the percentage of sites of PD ≥ 6mm and the number of missing tooth was recorded A graduated manual periodontal probe was used to take measurements at the 6 sites of each tooth. BOP (%) and plaque score (%) were collected as well as tooth mobility with a score from 1 to 3 . The furcation impairments were diagnosed with a Nabers probe according to the classification of Hamp and the Inflamed Surface Area (PISA) was calculated. Patients were classified according to the new periodontal classification identifying the grade, the stage and the extend of the periodontitis. Patient-reported outcome measures (PROMs) A questionnaire using a visual analogue scale (VAS) was given to all participants regarding their oral hygiene habits, and perception about oral esthetic. The following questions were subjected to the patients: nine questions graduated scale from 0 to 10: 1/"How do you judge your degree of oral hygiene?", 2/"What is the frequency of utilization of interdental brushing?", 3/"Do you like the color of your teeth? , 4/"Your teeth are there sensitive to cold? , 5/ "How do you judge your degree of gingival health? , 6/ "How do you judge the esthetic aspect of you gum?", 7/ "Do you like the color of your gum? ", 8/ "Does your gum bleed during brushing?", 9/ "How do you judge your breath?". sample size: The study was powered to detect a minimum clinically significant difference in probing depth (PD) of 0.5 mm between patients, using α= 0.05. The probing depth at baseline was considered covariate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis
    Keywords
    smoking, oral hygiene

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    at baseline, patients recieved oral hygiene instructions The same examiner (LS) performed an oral demonstration including teeth brushing, interdental cleaning and tong wash. Each patient received proper head and interdental brushes demonstration, moreover, patients were educated to brush their ventral face of their tong A single periodontist (L.S) performed the supra gingival debridment at the second appointment (2 weeks after receiving OHI) , followed 2 weeks after by a full month debridement using ultrason piezoelectric device (Newtron P5 XS Bled, Acteon, Satelec , France) with specific micro-inserts (H1, H3, H4L, H4R)
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    non smokers
    Arm Type
    Other
    Arm Description
    patient who never smoked
    Arm Title
    former smoker
    Arm Type
    Other
    Arm Description
    patient who smoked in the past
    Arm Title
    smoker
    Arm Type
    Other
    Arm Description
    patient who still smoke
    Intervention Type
    Procedure
    Intervention Name(s)
    mechanical plaque control
    Intervention Description
    supra and sub gingival debridment ( plaque control)
    Primary Outcome Measure Information:
    Title
    Change from baseline of probing depth (PD)
    Description
    PD was measured , in millimetern with periodontal probe, at 6 sites of each tooth
    Time Frame
    2 weeks after baseline and 3 month after PNST
    Secondary Outcome Measure Information:
    Title
    Change from baseline of BOP (bleeding on probing)
    Description
    BOP was measured , in percentage of bleeding, at 6 sites of each tooth
    Time Frame
    2 weeks after baseline and 3 month after PNST

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aged of minimum 18 years old chronic periodontitis presence of a minimum of 6 teeth at each arch a minimum of 6 teeth with pocket depth of 5 mm signed the informed consent Exclusion Criteria: aggressive periodontitis diabetes connective tissue disease pregnancy radio-therapy chemotherapy psychological disease previous periodontal therapy

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Periodontal Treatment in Non Smokers, Former Smokers and Smokers

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