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

An observational study of Periodontitis and Smoking Habit, run by Trakya University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 35 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Periodontitis, Smoking Habit, Subgingival Plaque
What is being tested?: Non-surgical periodontal therapy
Type of treatment: Pill or oral medicine, Surgery or procedure
How many people: 48 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Sep 2018to 1 Mar 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Trakya University
Edirne, 22030

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Conditions: Periodontitis, Smoking Habit, Subgingival Plaque
Being tested: Non-surgical periodontal therapy
Medical subject headings: Periodontitis, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-surgical periodontal therapyProcedure or surgery
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.

Study groups in NCT06383455
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Non-surgical periodontal therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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%).
Measured: Baseline and four weeks after the periodontal therapy.

Secondary outcomes (5)

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
Measured: Baseline and 4 weeks after periodontal therapy
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
Measured: Baseline and 4 weeks after periodontal therapy
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;
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.
Measured: Baseline and 4 weeks after periodontal therapy
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
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.
Measured: Baseline and 4 weeks after periodontal therapy
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 %.
Measured: Baseline and 4 weeks after periodontal therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 20181 Mar 2019

First posted25 Apr 2024
Study start15 Sep 2018
Primary completion1 Feb 2019
Study completion1 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for PeriodontitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06383455
Sponsor's protocol ID: Observational
Status last verified: Apr 2024
First submitted: 18 Apr 2024
Last updated: 25 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Researchers will consider sharing the entire protocol and statistical plan with other researchers after this study is published as a scientific article

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.
PubMed 21208407
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.
PubMed 12834497
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.
PubMed 15655029
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.
PubMed 9150643
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.
PubMed 15691352
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.
PubMed 19563330
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. 2026 May;24(2):265-277. doi: 10.1111/idh.70007. Epub 2025 Nov 25.
PubMed 41290565

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Smoking on Clinical and Microbiological Response Following Non-Surgical Periodontal Treatment in Periodontitis Patients
ClinicalTrials.gov ID: NCT06383455
Acronym / sponsor ID: Observational
Conditions: Periodontitis, Smoking Habit, Subgingival Plaque
Study type: Observational
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Trakya UniversityUniversity, hospital or other
Study start: 15 Sep 2018 (actual)
Primary completion: 1 Feb 2019 (actual)
Study completion: 1 Mar 2019 (actual)
First posted: 25 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Does smoking affect the results of non-surgical periodontal treatment on subgingival flora in participants with periodontal disease?

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Smoking individuals with periodontitis	–	Procedure: Non-surgical periodontal therapyThe 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	–	Procedure: Non-surgical periodontal therapyThe 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.

Who may qualify

Ages: 35 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Non-surgical periodontal therapyAn 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.	Procedure or surgery	Non-smoking individuals with periodontitis, Smoking individuals with periodontitis

Primary outcome

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) 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%).

5 secondary outcomes

Change in clinical attachment level (CAL)
Time frame: Baseline and 4 weeks after periodontal therapy
Change in probing depth (PD)
Time frame: Baseline and 4 weeks after periodontal therapy
Change in gingival index (GI) scores
Time frame: Baseline and 4 weeks after periodontal therapy
Change in plaque index (PI) scores
Time frame: Baseline and 4 weeks after periodontal therapy
Change in Bleeding on Probing (BOP)
Time frame: Baseline and 4 weeks after periodontal therapy

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
Background: PubMed 21208407Kubota 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.
Background: PubMed 12834497Van 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.
Background: PubMed 15655029Labriola 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.
Background: PubMed 9150643Grossi 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.
Background: PubMed 15691352Darby 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.
Background: PubMed 19563330Haffajee 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.
Derived from this study: PubMed 41290565Acikgoz-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. 2026 May;24(2):265-277. doi: 10.1111/idh.70007. Epub 2025 Nov 25.
Individual participant dataSharing planned: Undecided. Researchers will consider sharing the entire protocol and statistical plan with other researchers after this study is published as a scientific article

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ece Açıkgöz-Alparslan principal investigator

Trakya University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontitis and Smoking Habit, run by Trakya University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06383455, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.