Effects of Smoking on Clinical and Microbiological Response in Individuals With Periodontitis

April 24, 2024 updated by: Ece AÇIKGÖZ ALPARSLAN, Trakya University

Effects of Smoking on Clinical and Microbiological Response Following Non-Surgical Periodontal Treatment in Periodontitis Patients

This study aimed to compare the distribution of subgingival periodontal pathogens following non-surgical periodontal therapy in smoking and non-smoking people with periodontitis. The main question it aims to answer is:

- Does smoking affect the results of non-surgical periodontal treatment on subgingival flora in participants with periodontal disease?

Researchers performed non-surgical periodontal therapy on 48 participants with stage III/IV periodontitis and recorded clinical measurements. They obtained subgingival plaque samples from periodontal pockets at the onset and after four weeks of treatment, determining the level of periodontopathogens using a polymerase chain reaction-based method.

Study Overview

Detailed Description

The present study aims to compare the changes in clinical parameters and subgingival periodontopathogen rates (P. gingivalis, A. actinomycetemcomitans, T. forsythia, F. nucleatum, P. intermedia, T. denticola, P. micra, C. rectus, E. nodatum, Capnocytophaga spp, and E. corrodens) following full-mouth scaling and root planing procedures in participants with and without smoking habits.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Edirne, Turkey, 22030
        • Trakya University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consisted of a total of 48 systemically healthy adults who applied to the Trakya University Faculty of Dentistry with periodontal complaints. The participants had generalized stage III/IV periodontitis, determined according to the criteria stated by the 2017 World Workshop for the Classification of Periodontal Diseases and Conditions. These participants were divided into two groups according to self-reported smoking habits.

Description

Inclusion Criteria:

  • Having 15 or more permanent teeth (except third molars and teeth with endodontic lesions),
  • Having been diagnosed with generalized Stage III or IV periodontitis that progresses with periodontal support tissue loss in more than 30% of the teeth,
  • Having at least five teeth with probing depth(PD) ≥6mm, clinical attachment level(CAL) ≥5mm, and radiographic bone loss that extends to at least the middle of the root,
  • Having at least one tooth that meets the same PD and CAL criteria per quadrant.

Exclusion Criteria:

  • Pregnancy or lactation,
  • Any systemic disease with a potential influence on the immune response (diabetes mellitus, bone metabolic diseases, immunosuppressive therapy, radiation etc.),
  • Existence of decay, restoration, or prosthesis on the sampling site,
  • Use of the anti-inflammatory drug and antibiotic within the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Smoking individuals with periodontitis
The participants were divided into two groups according to self-reported smoking habits. The smoker group consisted of individuals with stage 3/4 periodontitis who smoked at least ten cigarettes per day for at least five years.
An ultrasonic device (Cavitron Plus, Dentsply®, Duisburg, Germany) and periodontal hand instruments (periodontal curettes; Chicago, IL) were used for non-surgical periodontal treatment. The treatment procedure also included detailed oral hygiene instructions and full-mouth scaling and root planing. Scaling and root planing (SRP) was applied to all four quadrants under local anesthesia in a single appointment. No medication or mouthwash was prescribed to the patients.
Non-smoking individuals with periodontitis
The non-smoker group consisted of individuals with Stage 3/4 periodontitis who had never smoked in a lifetime or had quit smoking at least two years ago.
An ultrasonic device (Cavitron Plus, Dentsply®, Duisburg, Germany) and periodontal hand instruments (periodontal curettes; Chicago, IL) were used for non-surgical periodontal treatment. The treatment procedure also included detailed oral hygiene instructions and full-mouth scaling and root planing. Scaling and root planing (SRP) was applied to all four quadrants under local anesthesia in a single appointment. No medication or mouthwash was prescribed to the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in levels of periodontopathogens in subgingival plaque after non-surgical periodontal therapy in smokers and non-smokers with stage 3/4 periodontitis
Time Frame: Baseline and four weeks after the periodontal therapy.

The baseline levels of periodontopathogens (P. gingivalis, A. actinomycetemcomitans, T. forsythia, F. nucleatum, P. intermedia, T. denticola, P. micra, C. rectus, E. nodatum, Capnocytophaga spp, and E. corrodens), post-treatment levels, and elimination levels with treatment were evaluated using multiplex polymerase chain reaction (PCR) analysis.The observed rates of microorganisms were assessed by determining six main levels.

0: No colouring (<1% no bacteria)

  1. Very light-colored staining (Determination of bacteria from 1% to 20%).
  2. Light colored staining (Determination of bacteria from 21% to 40%),
  3. Moderate colored staining (Determination of bacteria from 41% to 60%),
  4. Dark colored staining (Determination of bacteria from 61% to 80%),
  5. Very dark-colored staining (Determination of bacteria from 81% to 100%).
Baseline and four weeks after the periodontal therapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinical attachment level (CAL)
Time Frame: Baseline and 4 weeks after periodontal therapy

CAL is the main clinical parameter indicating the severity of periodontal disease. CAL measurements were performed on six different surfaces of each tooth (disto-buccal/labial, mid-buccal/labial, mesio-buccal/labial, disto-lingual, mid-lingual, and mesio lingual) by using a periodontal probe (Williams probe; Chicago, IL) and average value was calculated in millimeters.

CAL 1-2 mm: Stage 1 periodontitis CAL 3-4 mm: Stage 2 periodontitis CAL ≥ 5 mm: Stage 3/4 periodontitis

Baseline and 4 weeks after periodontal therapy
Change in probing depth (PD)
Time Frame: Baseline and 4 weeks after periodontal therapy

PD is one of the clinical parameters indicating the severity of periodontal disease. PD measurements were performed on six different surfaces of each tooth (disto-buccal/labial, mid-buccal/labial, mesio-buccal/labial, disto-lingual, mid-lingual, and mesio lingual) by using a periodontal probe (Williams probe; Chicago, IL) and average value was calculated in millimeters.

PD ≤ 4 mm: Stage 1 periodontitis PD ≤ 5 mm: Stage 2 periodontitis PD ≥ 6 mm: Stage 3/4 periodontitis

Baseline and 4 weeks after periodontal therapy
Change in gingival index (GI) scores
Time Frame: Baseline and 4 weeks after periodontal therapy

GI is a clinical parameter indicating the severity of gingival inflammation. GI scores were noted for four different surfaces of each tooth (buccal, distal, mesial and lingual) and average value was calculated.

0 = normal gingiva;

  1. = mild inflammation: slight change in color, slight edema, no bleeding on probing;
  2. = moderate inflammation: redness, edema, and glazing, or bleeding on probing;
  3. = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding.
Baseline and 4 weeks after periodontal therapy
Change in plaque index (PI) scores
Time Frame: Baseline and 4 weeks after periodontal therapy

PI is a clinical parameter indicating the severity of dental plaque accumulation and oral hygiene habits of individuals. PI scores were noted for four different surfaces of each tooth (buccal, distal, mesial and lingual) and average value was calculated.

0 = No plaque

  1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
  2. = Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
  3. = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Baseline and 4 weeks after periodontal therapy
Change in Bleeding on Probing (BOP)
Time Frame: Baseline and 4 weeks after periodontal therapy
BOP is one the clinical parameters indicating the severity of gingival inflammation. BOP were noted as positive or negative for four different surfaces of each tooth (buccal, distal, mesial and lingual) and average positive value was calculated in %.
Baseline and 4 weeks after periodontal therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ece Açıkgöz-Alparslan, Trakya University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2018

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Observational

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Researchers will consider sharing the entire protocol and statistical plan with other researchers after this study is published as a scientific article

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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