SmokingNCT06191497
The Effect of Smoking and Chlorhexidine on Periodontal Tissues After Non- Surgical Periodontal Therapy in Patients With Periodontitis
A study testing non surgical periodontal therapy and Chlorhexidine mouthwash in people with Smoking and Periodontitis, run by University of Rijeka at 1 site in Croatia.
Trial summary
The aim of this study is to evaluate whether the use of a chlorhexidine based oral antiseptic will improve clinical results of non-surgical periodontal therapy (NSPT) in smokers with periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Periodontitis, Periodontal Diseases
- What is being tested?
- non surgical periodontal therapy and Chlorhexidine mouthwash
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- 14 Mar 2022to 1 May 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with periodontitis smokers and non smokers.
Who cannot join
- minors, pregnant woman, patients with systemic diseases affecting periodontal tissues, immunodeficient patients, patients who used antibiotics in the previous six months, patients with orthodontic appliances or retainers and patients who previously had periodontal therapy or were in supportive therapy
- Patients smoking e-cigarettes, tobacco heating systems, cigarettes without filter and occasional smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nicotine Exposure on Periodontal Tissues After Non- Surgical Periodontal Therapy With and Without the Use of a Chlorhexidine-based Antiseptic in Patients With Periodontitis
The aim of this study is to evaluate whether the use of a chlorhexidine based oral antiseptic will improve clinical results of non-surgical periodontal therapy (NSPT) in smokers with periodontitis.
A randomized controlled clinical trial will be carried out on 60 subjects with periodontitis- 30 smokers and 30 non-smokers. All subjects will be clinically examined. The following periodontal indices will be measured: Full mouth plaque score (FMPS), Full mouth bleeding score (FMBS), Pocket probing depth (PPD), Clinical attachment level (CAL), Gingival recession (GR) and Tooth mobility (TM). All subjects will have NSPT carried out. Half of the subjects in each group will use a 0.12% chlorhexidine based mouth rinse twice a day during 15 days. Clinical examination will be repeated 8 weeks after NSPT and compared.
Read the detailed description
A total of 60 subject will be recruited among patients seeking periodontal treatment at the Department. All subjects will have periodontitis diagnosed according to the criteria outlined in the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions. The subjects will be divided into two groups based on smoking status. The first group of 30 subjects will consist of cigarettes smokers and the second group of 30 non- smokers. All the subjects in the first group smoke for a minimum of 3 years and at least 10 cigarettes a day. Patients smoking e-cigarettes, tobacco heating systems, cigarettes without filter and occasional smokers will be excluded from the study. Moreover, minors, pregnant woman, patients with systemic diseases affecting periodontal tissues, immunodeficient patients, patients who used antibiotics in the previous six months, patients with orthodontic appliances or retainers and patients who previously had periodontal therapy or were in supportive therapy will be excluded from the study. A randomization plan based on sex (male; female), age (</> 50 years), nicotine exposure (smoker; non-smoker) and intervention (with/ without CHX) will be made using an online randomization software. All subjects will undergo a clinical examination before and 8 weeks after non-surgical periodontal therapy. Clinical examination will include all teeth except third molars and will be carried out using a millimeter graduated PCP-15 UNC periodontal probe (Hu-Friedy, Chicago, USA). The following periodontal indices will be measured: Full mouth plaque score (FMPS), Full mouth bleeding score (FMBS), Pocket probing depth (PPD), Clinical attachment level (CAL), Gingival recession (GR) and Tooth mobility (TM).
All subjects will have non-surgical periodontal therapy carried out according to the principles of Guided biofilm therapy (GBT) (EMS Dental, Geneve, Switzerland) using AIRFLOW Prophylaxis Master ultrasonic instruments (EMS Dental, Geneve, Switzerland) and Gracey curettes (Hu- Friedy, Chicago, USA). Moreover, half of the subjects in each group, 15 smokers and 15 non-smokers, will use a 0.12% chlorhexidine-digluconate based mouthwash (Curasept ADS 212, Curasept SpA, Saronno, Italy) twice a day for one minute during a period of 15 days. Subsequently, four subgroups of 15 subjects will be formed- non-smokers (NS), non-smokers who used CHX (NS-CHX), smokers (S) and smokers who used CHX (S-CHX).
- Conditions
- Smoking, Periodontitis, Periodontal Diseases
- Being tested
- non surgical periodontal therapy, Chlorhexidine mouthwash
- Medical subject headings
- Smoking, Periodontitis, Periodontal Diseases
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
NSPT based on Guided biofilm therapy principle (EMS Dental, Switzerland)
Chlorhexidine mouthwashDrug
0.12% chlorhexidine based mouthwash used twice a day for 15 days after therapy
| Study group | Role | What they receive |
|---|---|---|
| Non-smokers | Active comparator | 15 non-smoking subjects with diagnosed periodontitis. All of them underwent NSPT Receives: Procedure: non surgical periodontal therapy |
| Non-smokers+ CHX | Experimental | 15 non-smoking subjects with diagnosed periodontitis. All of them underwent NSPT and used 0.12% chlorhexidine mouthwash for 15 days after therapy Receives: Procedure: non surgical periodontal therapy; Drug: Chlorhexidine mouthwash |
| Smokers | Active comparator | 15 cigarette smoking subjects with diagnosed periodontitis. All of them underwent NSPT Receives: Procedure: non surgical periodontal therapy |
| Smokers + CHX | Experimental | 15 cigarette smoking subjects with diagnosed periodontitis. All of them underwent NSPT and used 0.12% chlorhexidine mouthwash for 15 days after therapy Receives: Procedure: non surgical periodontal therapy; Drug: Chlorhexidine mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full mouth plaque score
plaque accumulation
Measured: 8 weeks
Full mouth bleeding score
gingival bleeding
Measured: 8 weeks
Pocket depth
periodontal pocket depth in mm
Measured: 8 weeks
Clinical attachment level
clinical attachment loss in mm
Measured: 8 weeks
Gingival recession
gingival recession in mm
Measured: 8 weeks
Tooth mobility
tooth mobility- Miller class
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start14 Mar 2022
- Primary completion16 Oct 2023
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandar Pupovac, University of Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191497
- Sponsor's protocol ID
- CHX 01/22
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only data not affecting participants personal data will be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nicotine Exposure on Periodontal Tissues After Non- Surgical Periodontal Therapy With and Without the Use of a Chlorhexidine-based Antiseptic in Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT06191497
- Acronym / sponsor ID
- CHX 01/22
- Conditions
- Smoking, Periodontitis, Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of RijekaUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 5 Jan 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.
The aim of this study is to evaluate whether the use of a chlorhexidine based oral antiseptic will improve clinical results of non-surgical periodontal therapy (NSPT) in smokers with periodontitis.
A randomized controlled clinical trial will be carried out on 60 subjects with periodontitis- 30 smokers and 30 non-smokers. All subjects will be clinically examined. The following periodontal indices will be measured: Full mouth plaque score (FMPS), Full mouth bleeding score (FMBS), Pocket probing depth (PPD), Clinical attachment level (CAL), Gingival recession (GR) and Tooth mobility (TM). All subjects will have NSPT carried out. Half of the subjects in each group will use a 0.12% chlorhexidine based mouth rinse twice a day during 15 days. Clinical examination will be repeated 8 weeks after NSPT and compared.
Detailed description
A total of 60 subject will be recruited among patients seeking periodontal treatment at the Department. All subjects will have periodontitis diagnosed according to the criteria outlined in the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions. The subjects will be divided into two groups based on smoking status. The first group of 30 subjects will consist of cigarettes smokers and the second group of 30 non- smokers. All the subjects in the first group smoke for a minimum of 3 years and at least 10 cigarettes a day. Patients smoking e-cigarettes, tobacco heating systems, cigarettes without filter and occasional smokers will be excluded from the study. Moreover, minors, pregnant woman, patients with systemic diseases affecting periodontal tissues, immunodeficient patients, patients who used antibiotics in the previous six months, patients with orthodontic appliances or retainers and patients who previously had periodontal therapy or were in supportive therapy will be excluded from the study. A randomization plan based on sex (male; female), age (</> 50 years), nicotine exposure (smoker; non-smoker) and intervention (with/ without CHX) will be made using an online randomization software. All subjects will undergo a clinical examination before and 8 weeks after non-surgical periodontal therapy. Clinical examination will include all teeth except third molars and will be carried out using a millimeter graduated PCP-15 UNC periodontal probe (Hu-Friedy, Chicago, USA). The following periodontal indices will be measured: Full mouth plaque score (FMPS), Full mouth bleeding score (FMBS), Pocket probing depth (PPD), Clinical attachment level (CAL), Gingival recession (GR) and Tooth mobility (TM).
All subjects will have non-surgical periodontal therapy carried out according to the principles of Guided biofilm therapy (GBT) (EMS Dental, Geneve, Switzerland) using AIRFLOW Prophylaxis Master ultrasonic instruments (EMS Dental, Geneve, Switzerland) and Gracey curettes (Hu- Friedy, Chicago, USA). Moreover, half of the subjects in each group, 15 smokers and 15 non-smokers, will use a 0.12% chlorhexidine-digluconate based mouthwash (Curasept ADS 212, Curasept SpA, Saronno, Italy) twice a day for one minute during a period of 15 days. Subsequently, four subgroups of 15 subjects will be formed- non-smokers (NS), non-smokers who used CHX (NS-CHX), smokers (S) and smokers who used CHX (S-CHX).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-smokers | Active comparator | Procedure: non surgical periodontal therapy15 non-smoking subjects with diagnosed periodontitis. All of them underwent NSPT |
| Non-smokers+ CHX | Experimental | Procedure: non surgical periodontal therapy, Drug: Chlorhexidine mouthwash15 non-smoking subjects with diagnosed periodontitis. All of them underwent NSPT and used 0.12% chlorhexidine mouthwash for 15 days after therapy |
| Smokers | Active comparator | Procedure: non surgical periodontal therapy15 cigarette smoking subjects with diagnosed periodontitis. All of them underwent NSPT |
| Smokers + CHX | Experimental | Procedure: non surgical periodontal therapy, Drug: Chlorhexidine mouthwash15 cigarette smoking subjects with diagnosed periodontitis. All of them underwent NSPT and used 0.12% chlorhexidine mouthwash for 15 days after therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with periodontitis smokers and non smokers.
Key exclusion criteria (2 listed)
- minors, pregnant woman, patients with systemic diseases affecting periodontal tissues, immunodeficient patients, patients who used antibiotics in the previous six months, patients with orthodontic appliances or retainers and patients who previously had periodontal therapy or were in supportive therapy
- Patients smoking e-cigarettes, tobacco heating systems, cigarettes without filter and occasional smokers
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 therapyNSPT based on Guided biofilm therapy principle (EMS Dental, Switzerland) | Procedure or surgery | Non-smokers, Non-smokers+ CHX, Smokers, Smokers + CHX |
| Chlorhexidine mouthwash0.12% chlorhexidine based mouthwash used twice a day for 15 days after therapy | Drug | Non-smokers+ CHX, Smokers + CHX |
Primary outcome
Full mouth plaque score
Time frame: 8 weeks
plaque accumulation
Full mouth bleeding score
Time frame: 8 weeks
gingival bleeding
Pocket depth
Time frame: 8 weeks
periodontal pocket depth in mm
Clinical attachment level
Time frame: 8 weeks
clinical attachment loss in mm
Gingival recession
Time frame: 8 weeks
gingival recession in mm
Tooth mobility
Time frame: 8 weeks
tooth mobility- Miller class
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No. only data not affecting participants personal data will be shared upon reasonable request
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non surgical periodontal therapy and Chlorhexidine mouthwash in people with Smoking and Periodontitis, run by University of Rijeka at 1 site in Croatia.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Jan 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 Croatia. 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?
Results are not available in the source record.
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?
Full mouth plaque score (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2024.