Effect of Nicotine Gingival Fibroblast Intoxication on the Response of Periodontal Treatment (ENIPT's)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Smoking Cessation; Periodontitis; Tobacco Dependence
• Intervention / Treatment: Procedure: periodontal 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 Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liege
    • Liège, Liege, Belgium, 4000
      • Departement of periodontology, buccal surgery and implantology- Uliège, Belgium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventionnal smoker group; patient who smokes conventionnal cigarette	Procedure: periodontal non-surgical treatment; 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.
Placebo Comparator: Non smoker group; patient who don't smoke cigarette	Procedure: periodontal non-surgical treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nicotine/cotinine in gum (ng/ml)	concentration cotinine and nicotine (ng/ml)	the day of the periodontal non surgical treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
PY (number/year)	number of packet of cigarettes smoked per year	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	the day of periodontal non-surgical treatment
Furc (I,II or III)	furcation involvement	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)	baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
BOP (%)	bleeding on probing	baseline, the day of periodontal non- surgical treatment(PNST) , 3,6 and 12 months after PNSTs after
PI (%)	plaque score	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	the day of periodontal non-surgical treatment

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: periodontitis; nicotine gingival intoxication; periodontal outcomes; periodontitis non surgical treatment
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Health Behavior; Periodontitis; Tobacco Use Disorder; Smoking Cessation
• Other Study ID Numbers: 2024/494

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No