PeriodontitisENIPT'sNCT07491627
Effect of Nicotine Gingival Fibroblast Intoxication on the Response of Periodontal Treatment
A study testing periodontal non-surgical treatment in people with Periodontitis and Smoking Cessation, run by University of Liege at 1 site in Belgium.
Trial summary
Impact of nicotine gingival intoxication on the clinical outcomes after periodontitis non surgical treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Smoking Cessation, Tobacco Dependence
- What is being tested?
- periodontal non-surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Jan 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- diabetes,
- connective tissue disease
- pregnancy
- radiotherapy
- chemotherapy
- psychological disease
- previous periodontal therapy
- antibiotics intake
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Departement of periodontology, buccal surgery and implantology- Uliège, Belgium
Liège, Liege, 4000
About this study
Official title: Effect of Nicotine Gingival Fibroblast Intoxication on the Response of Periodontal Treatment, in Conventional and Non Smokers: a Controlled Clinical Trial
Impact of nicotine gingival intoxication on the clinical outcomes after periodontitis non surgical treatment
Read the detailed description
In patients suffured of periodontitis, to evaluate the effect of nicotine gingival tissue intoxication and others smoking indicators on the severity of periodontitis and outcomes after nonsurgical periodontal treatment."
- Conditions
- Periodontitis, Smoking Cessation, Tobacco Dependence
- Being tested
- periodontal non-surgical treatment
- Keywords
- periodontitis, nicotine gingival intoxication, periodontal outcomes, periodontitis non surgical treatment
- Medical subject headings
- Periodontitis, Smoking Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal non-surgical treatmentProcedure or surgery
The procedure will consist of non-surgical periodontal treatment (NSPT), consisting of the removal of supra- and subgingival plaque using ultrasonic instruments.
Prior to the NSPT, all unstimulated saliva will be collected using Eppendorf.
During local anesthesia for the NSPT, a gingival tissue biopsy will be performed using a 2mm wide and 4mm deep punch in the maxillary retromolar area behind the last tooth in the arch.
| Study group | Role | What they receive |
|---|---|---|
| conventionnal smoker group | Active comparator | patient who smokes conventionnal cigarette Receives: Procedure: periodontal non-surgical treatment |
| Non smoker group | Placebo comparator | patient who don't smoke cigarette Receives: Procedure: periodontal non-surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
nicotine/cotinine in gum (ng/ml)
concentration cotinine and nicotine (ng/ml)
Measured: the day of the periodontal non surgical treatment
Secondary outcomes (9)
PD (mm)
periodontal pocket depth (mm) Secondary outcomes: percentage of sites with PD ≥ 6 mm, furcation involvement, mobility assessment, bleeding on probing score (BoP), plaque score (PI).
Measured: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
% PD ≥ 6 mm (%)
percentage of sites with PD ≥ 6 mm
Measured: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
FTND score ( 0 to 9)
Fagerström test for nictnie dependance ( scale from 0 to 9) 0-2: Very low dependence 3-4: Low dependence 5: Medium dependence 6-7: High dependence 8-10: Very high dependence
Measured: the day of periodontal non-surgical treatment
PY (number/year)
number of packet of cigarettes smoked per year
Measured: the day of periodontal non-surgical treatment
NCC (0 to 100)
number of cigartes consummed per day
- PK: number of packet of cigarettes smoked per year
- FTND: Fagerström test for nictnie dependance
Measured: the day of periodontal non-surgical treatment
Furc (I,II or III)
furcation involvement
Measured: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
periodontal ouctomes
tooth mobility ( 1,2 or 3)
Measured: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
BOP (%)
bleeding on probing
Measured: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
PI (%)
plaque score
Measured: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start6 Jan 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- comparison between smokers and non-smokers
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Salhi, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491627
- Sponsor's protocol ID
- 2024/494
- Acronym
- ENIPT's
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nicotine Gingival Fibroblast Intoxication on the Response of Periodontal Treatment, in Conventional and Non Smokers: a Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07491627
- Acronym / sponsor ID
- ENIPT's / 2024/494
- Conditions
- Periodontitis, Smoking Cessation, Tobacco Dependence
- Keywords
- periodontitis, nicotine gingival intoxication, periodontal outcomes, periodontitis non surgical treatment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 24 Mar 2026 (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.
Impact of nicotine gingival intoxication on the clinical outcomes after periodontitis non surgical treatment
Detailed description
In patients suffured of periodontitis, to evaluate the effect of nicotine gingival tissue intoxication and others smoking indicators on the severity of periodontitis and outcomes after nonsurgical periodontal treatment."
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- comparison between smokers and non-smokers
| Arm | Type | Receives |
|---|---|---|
| conventionnal smoker group | Active comparator | Procedure: periodontal non-surgical treatmentpatient who smokes conventionnal cigarette |
| Non smoker group | Placebo comparator | Procedure: periodontal non-surgical treatmentpatient who don't smoke cigarette |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- diabetes,
- connective tissue disease
- pregnancy
- radiotherapy
- chemotherapy
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 |
|---|---|---|
| periodontal non-surgical treatmentThe procedure will consist of non-surgical periodontal treatment (NSPT), consisting of the removal of supra- and subgingival plaque using ultrasonic instruments. Prior to the NSPT, all unstimulated saliva will be collected using Eppendorf. During local anesthesia for the NSPT, a gingival tissue biopsy will be performed using a 2mm wide and 4mm deep punch in the maxillary retromolar area behind the last tooth in the arch. | Procedure or surgery | Non smoker group, conventionnal smoker group |
Primary outcome
nicotine/cotinine in gum (ng/ml)
Time frame: the day of the periodontal non surgical treatment
concentration cotinine and nicotine (ng/ml)
9 secondary outcomes
PD (mm)
Time frame: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
% PD ≥ 6 mm (%)
Time frame: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
FTND score ( 0 to 9)
Time frame: the day of periodontal non-surgical treatment
PY (number/year)
Time frame: the day of periodontal non-surgical treatment
NCC (0 to 100)
Time frame: the day of periodontal non-surgical treatment
Furc (I,II or III)
Time frame: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
periodontal ouctomes
Time frame: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
BOP (%)
Time frame: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
PI (%)
Time frame: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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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.
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 periodontal non-surgical treatment in people with Periodontitis and Smoking Cessation, run by University of Liege at 1 site in Belgium.
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 0 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 22 Apr 2026. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
nicotine/cotinine in gum (ng/ml) (time frame: the day of the periodontal non surgical treatment). 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 22 Apr 2026.