Clinical Trials Directory

Trials / Completed

CompletedNCT04061460

Periodontal Treatment in Non Smokers, Former Smokers and Smokers

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
75 (actual)
Sponsor
University of Liege · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREmechanical plaque controlsupra and sub gingival debridment ( plaque control)

Timeline

Start date
2014-09-01
Primary completion
2015-07-01
Completion
2016-07-01
First posted
2019-08-19
Last updated
2019-08-22

Source: ClinicalTrials.gov record NCT04061460. Inclusion in this directory is not an endorsement.