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NCT Number: NCT06383455

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

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.

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Key information

Conditions

Periodontitis Behavior Mouth Diseases Periodontal Diseases Smoking Smoking Habit Stomatognathic Diseases Subgingival Plaque

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Trakya University

Edirne, 22030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-surgical periodontal therapy

Procedure

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.

Primary outcomes

  1. 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)

    • Very light-colored staining (Determination of bacteria from 1% to 20%).
    • Light colored staining (Determination of bacteria from 21% to 40%),
    • Moderate colored staining (Determination of bacteria from 41% to 60%),
    • Dark colored staining (Determination of bacteria from 61% to 80%),
    • Very dark-colored staining (Determination of bacteria from 81% to 100%).

Secondary outcomes

  1. 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

  2. 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

  3. 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;

    • = mild inflammation: slight change in color, slight edema, no bleeding on probing;
    • = moderate inflammation: redness, edema, and glazing, or bleeding on probing;
    • = severe inflammation: marked redness and edema, tendency toward spontaneous bleeding.

  4. 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

    • = 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.
    • = Moderate accumulation of soft deposits within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
    • = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

  5. 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 %.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 25, 2024
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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