Clinical trial NCT06383455: Effects of Smoking on Clinical and Microbiological Response in Individuals With Periodontitis
Official title: Effects of Smoking on Clinical and Microbiological Response Following Non-Surgical Periodontal Treatment in Periodontitis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Smoking Habit
Subgingival Plaque
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 48
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in levels of periodontopathogens in subgingival plaque after non-surgical periodontal therapy in smokers and non-smokers with stage 3/4 periodontitis
timeFrame: Baseline and four weeks after the periodontal therapy.
Secondary outcomes:
measure: Change in clinical attachment level (CAL)
timeFrame: Baseline and 4 weeks after periodontal therapy
measure: Change in probing depth (PD)
timeFrame: Baseline and 4 weeks after periodontal therapy
measure: Change in gingival index (GI) scores
timeFrame: Baseline and 4 weeks after periodontal therapy
measure: Change in plaque index (PI) scores
timeFrame: Baseline and 4 weeks after periodontal therapy
measure: Change in Bleeding on Probing (BOP)
timeFrame: Baseline and 4 weeks after periodontal therapy
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
Study officials:
affiliation: Trakya University
name: Ece Açıkgöz-Alparslan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kubota M, Tanno-Nakanishi M, Yamada S, Okuda K, Ishihara K. Effect of smoking on subgingival microflora of patients with periodontitis in Japan. BMC Oral Health. 2011 Jan 5;11:1. doi: 10.1186/1472-6831-11-1.
citation: Van der Velden U, Varoufaki A, Hutter JW, Xu L, Timmerman MF, Van Winkelhoff AJ, Loos BG. Effect of smoking and periodontal treatment on the subgingival microflora. J Clin Periodontol. 2003 Jul;30(7):603-10. doi: 10.1034/j.1600-051x.2003.00080.x.
citation: Labriola A, Needleman I, Moles DR. Systematic review of the effect of smoking on nonsurgical periodontal therapy. Periodontol 2000. 2005;37:124-37. doi: 10.1111/j.1600-0757.2004.03793.x. No abstract available.
citation: Grossi SG, Zambon J, Machtei EE, Schifferle R, Andreana S, Genco RJ, Cummins D, Harrap G. Effects of smoking and smoking cessation on healing after mechanical periodontal therapy. J Am Dent Assoc. 1997 May;128(5):599-607. doi: 10.14219/jada.archive.1997.0259.
citation: Darby IB, Hodge PJ, Riggio MP, Kinane DF. Clinical and microbiological effect of scaling and root planing in smoker and non-smoker chronic and aggressive periodontitis patients. J Clin Periodontol. 2005 Feb;32(2):200-6. doi: 10.1111/j.1600-051X.2005.00644.x.
citation: Haffajee AD, Yaskell T, Torresyap G, Teles R, Socransky SS. Comparison between polymerase chain reaction-based and checkerboard DNA hybridization techniques for microbial assessment of subgingival plaque samples. J Clin Periodontol. 2009 Aug;36(8):642-9. doi: 10.1111/j.1600-051X.2009.01434.x. Epub 2009 Jun 26.