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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06383455
• Other study ID #: Observational
• Status: Completed
• Start date: September 15, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2024
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis
• Smoking Habit
• Subgingival Plaque

Intervention

Procedure:
• Non-surgical periodontal therapy
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.

Locations

Country	Name	City	State
Turkey	Trakya University	Edirne

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in levels of periodontopathogens in subgingival plaque after non-surgical periodontal therapy in smokers and non-smokers with stage 3/4 periodontitis	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%).	Baseline and four weeks after the periodontal therapy.
Secondary	Change in clinical attachment level (CAL)	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
Secondary	Change in probing depth (PD)	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
Secondary	Change in gingival index (GI) scores	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.	Baseline and 4 weeks after periodontal therapy
Secondary	Change in plaque index (PI) scores	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.	Baseline and 4 weeks after periodontal therapy
Secondary	Change in Bleeding on Probing (BOP)	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