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Enrolling by Invitation

NCT Number: NCT07491627

Effect of Nicotine Gingival Fibroblast Intoxication on the Response of Periodontal Treatment

Impact of nicotine gingival intoxication on the clinical outcomes after periodontitis non surgical treatment

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Key information

Conditions

Periodontitis Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Mouth Diseases Periodontal Diseases Smoking Cessation Stomatognathic Diseases Substance-Related Disorders Tobacco Dependence Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departement of periodontology, buccal surgery and implantology- Uliège, Belgium

Liège, Liege, 4000, Belgium

About this study

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."

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patient suffured of periodontitis, smoker and non-smoker

  • patient suffured of periodontitis
  • smoker and non-smoker
  • presence of a minimum of 6 teeth at each arch
  • minimum of 6 teeth with pocket depth of 5 mm
  • signed informed consent

Exclusion criteria

  • diabetes,
  • connective tissue disease
  • pregnancy
  • radiotherapy
  • chemotherapy
  • psychological disease
  • previous periodontal therapy
  • antibiotics intake

Treatment and study plan

periodontal non-surgical treatment

Procedure

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.

Primary outcomes

  1. nicotine/cotinine in gum (ng/ml)

    Time frame: the day of the periodontal non surgical treatment

    concentration cotinine and nicotine (ng/ml)

Secondary outcomes

  1. PD (mm)

    Time frame: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after

    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).

  2. % PD ≥ 6 mm (%)

    Time frame: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after

    percentage of sites with PD ≥ 6 mm

  3. FTND score ( 0 to 9)

    Time frame: the day of periodontal non-surgical treatment

    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

  4. PY (number/year)

    Time frame: the day of periodontal non-surgical treatment

    number of packet of cigarettes smoked per year

  5. NCC (0 to 100)

    Time frame: the day of periodontal non-surgical treatment

    number of cigartes consummed per day

    • PK: number of packet of cigarettes smoked per year
    • FTND: Fagerström test for nictnie dependance

  6. Furc (I,II or III)

    Time frame: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after

    furcation involvement

  7. periodontal ouctomes

    Time frame: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after

    tooth mobility ( 1,2 or 3)

  8. BOP (%)

    Time frame: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after

    bleeding on probing

  9. PI (%)

    Time frame: baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after

    plaque score

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Effect of Nicotine Gingival Fibroblast Intoxication on the Response of Periodontal Treatment, in Conventional and Non Smokers: a Controlled Clinical Trial

Acronym: ENIPT's

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Mar 24, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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