Periodontal Treatment in Non Smokers, Former Smokers and Smokers

NCT04061460 | Completed

• 1 other identifier: B707201421977
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis

Keywords

smoking; oral hygiene

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline of BOP (bleeding on probing)

  2 weeks after baseline and 3 month after PNST

Study Arms (3)

non smokers

OTHER

patient who never smoked

Procedure: mechanical plaque control

former smoker

OTHER

patient who smoked in the past

Procedure: mechanical plaque control

smoker

OTHER

patient who still smoke

Procedure: mechanical plaque control

Interventions

mechanical plaque control PROCEDURE

supra and sub gingival debridment ( plaque control)

former smoker; non smokers; smoker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• aggressive periodontitis
• diabetes
• connective tissue disease
• pregnancy
• radio-therapy
• chemotherapy
• psychological disease
• previous periodontal therapy

Sponsors & Collaborators

• University of Liege: lead

MeSH Terms

Conditions

Periodontitis; Smoking

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, head of clinic,Department of Periodontology

Model Details: 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)

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 19, 2019
• Study Start: September 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: August 22, 2019

Record last verified: 2019-08