NCT06383455

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

April 18, 2024

Last Update Submit

April 24, 2024

Conditions

Outcome Measures

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

    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%).

    Baseline and four weeks after the periodontal therapy.

Secondary Outcomes (5)

  • Change in clinical attachment level (CAL)

    Baseline and 4 weeks after periodontal therapy

  • Change in probing depth (PD)

    Baseline and 4 weeks after periodontal therapy

  • Change in gingival index (GI) scores

    Baseline and 4 weeks after periodontal therapy

  • Change in plaque index (PI) scores

    Baseline and 4 weeks after periodontal therapy

  • Change in Bleeding on Probing (BOP)

    Baseline and 4 weeks after periodontal therapy

Study Arms (2)

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.

Procedure: Non-surgical periodontal therapy

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.

Procedure: Non-surgical periodontal therapy

Interventions

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 periodontitisSmoking individuals with periodontitis

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, 22030, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 21208407BACKGROUND
  • 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.

    PMID: 12834497BACKGROUND
  • 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.

    PMID: 15655029BACKGROUND
  • 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.

    PMID: 9150643BACKGROUND
  • 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.

    PMID: 15691352BACKGROUND
  • 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.

    PMID: 19563330BACKGROUND
  • Acikgoz-Alparslan E, Eryildiz C, Inanc B. Effects of Smoking on Clinical and Microbiological Response Following Non-Surgical Periodontal Treatment in Periodontitis Patients. Int J Dent Hyg. 2025 Nov 25. doi: 10.1111/idh.70007. Online ahead of print.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Subgingival microbial dental plaque samples

MeSH Terms

Conditions

PeriodontitisSmoking

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBehavior

Study Officials

  • Ece Açıkgöz-Alparslan

    Trakya University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 25, 2024

Study Start

September 15, 2018

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations