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

Completed

• Conditions: Subgingival Plaque; Periodontitis; Smoking Habit
• Interventions: Procedure: Non-surgical periodontal therapy

• Registration Number: NCT06383455
• Lead Sponsor: Trakya University

Brief Summary

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.

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 Timeline

• Study Start: 2018-09-15
• Primary Completion: 2019-02-01
• Study Completion: 2019-03-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Study First Posted: 2024-04-25
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Smoking individuals with periodontitis	Non-surgical periodontal therapy	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.
Non-smoking individuals with periodontitis	Non-surgical periodontal therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in levels of periodontopathogens in subgingival plaque after non-surgical periodontal therapy in smokers and non-smokers with stage 3/4 periodontitis	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%).

Secondary Outcome Measures

Name	Time	Method
Change in probing depth (PD)	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
Change in Bleeding on Probing (BOP)	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 %.
Change in clinical attachment level (CAL)	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
Change in plaque index (PI) scores	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.
Change in gingival index (GI) scores	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.

Trial Locations

Locations (1)

Trakya University; 🇹🇷 Edirne, Turkey