Periodontal Treatment in Non Smokers, Former Smokers and Smokers

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04061460
• Other study ID #: B707201421977
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: July 1, 2016

Study information

• Verified date: August 2019
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 1, 2016
• Est. primary completion date: July 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• mechanical plaque control
supra and sub gingival debridment ( plaque control)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of probing depth (PD)	PD was measured , in millimetern with periodontal probe, at 6 sites of each tooth	2 weeks after baseline and 3 month after PNST
Secondary	Change from baseline of BOP (bleeding on probing)	BOP was measured , in percentage of bleeding, at 6 sites of each tooth	2 weeks after baseline and 3 month after PNST