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Periodontal Treatment in Non Smokers, Former Smokers and Smokers

U

University of Liege

Status

Completed

Conditions

Periodontitis

Treatments

Procedure: mechanical plaque control

Study type

Interventional

Funder types

Other

Identifiers

NCT04061460
B707201421977

Details and patient eligibility

About

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.

Full 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.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 3 patient groups

non smokers
Other group
Description:
patient who never smoked
Treatment:
Procedure: mechanical plaque control
former smoker
Other group
Description:
patient who smoked in the past
Treatment:
Procedure: mechanical plaque control
smoker
Other group
Description:
patient who still smoke
Treatment:
Procedure: mechanical plaque control

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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