- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06383455
Effects of Smoking on Clinical and Microbiological Response in Individuals With Periodontitis
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
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Edirne, Turkey, 22030
- Trakya University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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)
|
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;
|
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
|
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
Sponsor
Investigators
- Principal Investigator: Ece Açıkgöz-Alparslan, Trakya University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Observational
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Periodontitis
-
Mahsa UniversityRecruitingPeriodontitis | Periodontitis Chronic Generalized Moderate | Periodontitis (Stage 3) | Periodontitis, Adult | Periodontitis Chronic Generalized Severe | Periodontitis, Chronic | Periodontitis Stage II | Periodontitis Chronic Localized Slight | Periodontitis Stage IIIMalaysia
-
Shanghai Ninth People's Hospital Affiliated to...Not yet recruitingPeriodontitis Stage II | Periodontitis Stage III | Periodontitis Stage IV
-
Misr University for Science and TechnologyCompletedPeriodontitis | Periodontitis Stage I | Periodontitis Stage II | Periodontitis Stage IIIEgypt
-
Cairo UniversityRecruitingPeriodontitis | Periodontitis Stage II | Periodontitis Stage IIIEgypt
-
Ataturk UniversityCompletedPeriodontitis | Periodontitis Stage I | Periodontitis Stage IITurkey (Türkiye)
-
Al-Azhar UniversityNot yet recruitingStage IV Periodontitis | Advanced Periodontitis | Stage III PeriodontitisEgypt
-
Panineeya Mahavidyalaya Institute of Dental Sciences...Research Institute for Genetic and Human TherapyUnknownGeneralized Adult Periodontitis
-
Duygu DegirmenciogluNot yet recruitingApical PeriodontitisTurkey (Türkiye)
-
University of ZagrebActive, not recruitingApical PeriodontitisCroatia
-
Azienda Socio Sanitaria Territoriale degli Spedali...Università degli Studi di FerraraCompletedPeriodontitis, Aggressive | Periodontitis, AdultItaly
Clinical Trials on Non-surgical periodontal therapy
-
Cairo UniversityGulf Medical UniversityNot yet recruiting
-
Medipol UniversityCompletedPeriodontitis | Periodontal Therapy | Probiotic | Oral Hygiene, Oral HealthUnited States
-
CAIO VINICIUS GONÇALVES ROMAN TORRESCompletedRheumatoid Arthritis | Periodontitis
-
Ain Shams UniversityRecruiting
-
University of SharjahRecruitingInflammation | PeriodontitisUnited Arab Emirates
-
University of SienaNot yet recruitingPeriodontal Therapy | Non Responding Sites
-
Second Affiliated Hospital, School of Medicine,...RecruitingBiomarkers | Hyperlipidemia | Serum | Periodontitis Chronic Generalized Severe | Gingival Crevicular Fluid | Non-surgical Periodontal TherapyChina
-
University of FlorenceActive, not recruitingDiabetes Mellitus | Diabetes | Diabetes Mellitus, Type 1 | Periodontitis | Periodontal Diseases | Type 1 DiabetesItaly
-
Future University in EgyptCompletedEffect of Non Surgical Periodontal Therapy on Inflammatory Markers in Chronic Periodontitis PatientsAggressive PeriodontitisEgypt