Effect of Nicotine Gingival Fibroblast Intoxication on the Response of Periodontal Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: periodontal non-surgical treatment.
- Who it may be relevant to
- Registry conditions: Periodontitis, Smoking Cessation, Tobacco Dependence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Nicotine Gingival Fibroblast Intoxication on the Response of Periodontal Treatment, in Conventional and Non Smokers: a Controlled Clinical Trial
Overview
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."
Interventions
- 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.
Primary outcome measures
- nicotine/cotinine in gum (ng/ml) [Time frame: the day of the periodontal non surgical treatment]
Secondary outcome measures (9)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Belgium · 1 center
- Departement of periodontology, buccal surgery and implantology- Uliège, Belgium — Liège
Identifiers
NCT: NCT07491627 · 2024/494