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Completed

NCT Number: NCT04061460

Periodontal Treatment in Non Smokers, Former Smokers and Smokers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

mechanical plaque control

Procedure

supra and sub gingival debridment ( plaque control)

Primary outcomes

  1. Change from baseline of probing depth (PD)

    Time frame: 2 weeks after baseline and 3 month after PNST

    PD was measured , in millimetern with periodontal probe, at 6 sites of each tooth

Secondary outcomes

  1. Change from baseline of BOP (bleeding on probing)

    Time frame: 2 weeks after baseline and 3 month after PNST

    BOP was measured , in percentage of bleeding, at 6 sites of each tooth

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Aug 19, 2019
Registry last updated
Aug 22, 2019

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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