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

NCT07491627 | Enrolling By Invitation DMC

• 1 other identifier: 2024/494
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontitis; Smoking Cessation; Tobacco Dependence

Keywords

periodontitis; nicotine gingival intoxication; periodontal outcomes; periodontitis non surgical treatment

Outcome Measures

Primary Outcomes (1)

• nicotine/cotinine in gum (ng/ml)

  concentration cotinine and nicotine (ng/ml)

  the day of the periodontal non surgical treatment

Secondary Outcomes (9)

• PD (mm)

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

• % PD ≥ 6 mm (%)

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

• FTND score ( 0 to 9)

  the day of periodontal non-surgical treatment

• PY (number/year)

  the day of periodontal non-surgical treatment

• NCC (0 to 100)

  the day of periodontal non-surgical treatment

Study Arms (2)

conventionnal smoker group

ACTIVE COMPARATOR

patient who smokes conventionnal cigarette

Procedure: periodontal non-surgical treatment

Non smoker group

PLACEBO COMPARATOR

patient who don't smoke cigarette

Procedure: periodontal non-surgical treatment

Interventions

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.

Non smoker group; conventionnal smoker group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

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

Liège, Liege, 4000, Belgium

Location

MeSH Terms

Conditions

Periodontitis; Smoking Cessation; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD dental sciences

Model Details: comparison between smokers and non-smokers

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: March 24, 2026
• Study Start: January 6, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)