Effects of Smoking on Non-surgical Periodontal Therapy in Generalized Aggressive Periodontitis

NCT03512938 | Completed DMC

• 1 other identifier: 2014-DIS-013
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

Smoking is the major preventable risk factor in the initiation and progression of periodontal diseases. Periodontitis risk was found to be 3.9 times higher among smokers aged between 19-30 years and 2.8 times higher among smokers aged 31-40 years compared to non-smokers. Aggressive periodontitis (AgP), is characterized by a rapid attachment loss usually incompatible with the amount of plaque and dental calculus. It is often not possible to predict the prognosis of treatment with various treatment options in cases of aggressive periodontitis. It was hypothesized that non-smoker patients with generalized aggressive periodontitis (GAgP) will respond better to conventional mechanical non-surgical periodontal therapy compared to the smokers. Therefore, the aim of this study was to evaluate the effects of smoking on the outcomes of non-surgical periodontal treatment in terms of the clinical, biochemical and microbiological parameters.

Conditions

Generalized Aggressive Periodontitis; Smoking

Keywords

Generalized aggressive periodontitis; Non-surgical periodontal therapy; Periodontopathogens; Smoking; Gingival crevicular fluid

Outcome Measures

Primary Outcomes (1)

• Change in Clinical Attachment Level (CAL)

  Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy

Secondary Outcomes (7)

• Change in Probing Depth (PD)

  Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy

• Change in Bleeding on Probing (BoP)

  Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy

• Change in Plaque Index (PI)

  Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy

• Changing of the salivary biomarkers

  Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy

• Changing of the serum biomarkers

  Baseline and 1 month, 3 month, 6 month after non-surgical periodontal therapy

Study Arms (2)

Non-smoker Group

ACTIVE COMPARATOR

This group included non-smoker generalized aggressive periodontitis patients.

Procedure: Non-surgical periodontal therapy

Smoker Group

EXPERIMENTAL

This group included smoker generalized aggressive periodontitis patients.

Procedure: Non-surgical periodontal therapy

Interventions

Non-surgical periodontal therapy PROCEDURE

Patients were motivated and instructed to brush with modified Bass technique and use interdental toothbrushes, dental floss. Each patient underwent quadrant scaling and root planning (SRP) under local anaesthesia over a 4-week period. Root planing (RP) was performed under local anaesthesia (2% lidocaine, epinephrine 1:100.000) and a standard curette set newly sharpened with Arkansas stone was used for each patient.

Non-smoker Group; Smoker Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Having at least six permanent teeth, including incisors and/or first molars with severe periodontal disease
• Having at least one site with probing depth (PD) and clinical attachment level (CAL) ≥5 mm and six teeth other than first molars and incisors with similar PD and CAL measurements
• Familial aggregation

You may not qualify if:

• Medical disorders such as diabetes mellitus, immunological disorders
• Having an antibiotic or periodontal treatment in the last 6 months
• Having \<15 teeth

Sponsors & Collaborators

• Ege University: lead
• University of Glasgow: collaborator

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

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: Clinical Professor

Study Record Dates

• First Submitted: March 24, 2018
• First Posted: May 1, 2018
• Study Start: June 23, 2014
• Primary Completion: February 8, 2016
• Study Completion: September 28, 2017
• Last Updated: May 1, 2018

Record last verified: 2018-04