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
About this trial
This is an interventional treatment trial for Periodontitis focused on measuring smoking, oral hygiene
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
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
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
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Periodontal Treatment in Non Smokers, Former Smokers and Smokers
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