Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06191497
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-20
Brief Title:
The Effect of Smoking and Chlorhexidine on Periodontal Tissues After Non- Surgical Periodontal Therapy in Patients With Periodontitis
Sponsor:
University of Rijeka
Organization:
University of Rijeka
Study Overview
Official Title:
The Effect of Nicotine Exposure on Periodontal Tissues After Non- Surgical Periodontal Therapy With and Without the Use of a Chlorhexidine-based Antiseptic in Patients With Periodontitis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate whether the use of a chlorhexidine based oral antiseptic will improve clinical results of non-surgical periodontal therapy NSPT in smokers with periodontitis
A randomized controlled clinical trial will be carried out on 60 subjects with periodontitis- 30 smokers and 30 non-smokers All subjects will be clinically examined The following periodontal indices will be measured Full mouth plaque score FMPS Full mouth bleeding score FMBS Pocket probing depth PPD Clinical attachment level CAL Gingival recession GR and Tooth mobility TM All subjects will have NSPT carried out Half of the subjects in each group will use a 012 chlorhexidine based mouth rinse twice a day during 15 days Clinical examination will be repeated 8 weeks after NSPT and compared
A randomized controlled clinical trial will be carried out on 60 subjects with periodontitis- 30 smokers and 30 non-smokers All subjects will be clinically examined The following periodontal indices will be measured Full mouth plaque score FMPS Full mouth bleeding score FMBS Pocket probing depth PPD Clinical attachment level CAL Gingival recession GR and Tooth mobility TM All subjects will have NSPT carried out Half of the subjects in each group will use a 012 chlorhexidine based mouth rinse twice a day during 15 days Clinical examination will be repeated 8 weeks after NSPT and compared
Detailed Description:
A total of 60 subject will be recruited among patients seeking periodontal treatment at the Department All subjects will have periodontitis diagnosed according to the criteria outlined in the 2017 Classification of Periodontal and Peri-implant Diseases and Conditions The subjects will be divided into two groups based on smoking status The first group of 30 subjects will consist of cigarettes smokers and the second group of 30 non- smokers All the subjects in the first group smoke for a minimum of 3 years and at least 10 cigarettes a day Patients smoking e-cigarettes tobacco heating systems cigarettes without filter and occasional smokers will be excluded from the study Moreover minors pregnant woman patients with systemic diseases affecting periodontal tissues immunodeficient patients patients who used antibiotics in the previous six months patients with orthodontic appliances or retainers and patients who previously had periodontal therapy or were in supportive therapy will be excluded from the study A randomization plan based on sex male female age 50 years nicotine exposure smoker non-smoker and intervention with without CHX will be made using an online randomization software All subjects will undergo a clinical examination before and 8 weeks after non-surgical periodontal therapy Clinical examination will include all teeth except third molars and will be carried out using a millimeter graduated PCP-15 UNC periodontal probe Hu-Friedy Chicago USA The following periodontal indices will be measured Full mouth plaque score FMPS Full mouth bleeding score FMBS Pocket probing depth PPD Clinical attachment level CAL Gingival recession GR and Tooth mobility TM
All subjects will have non-surgical periodontal therapy carried out according to the principles of Guided biofilm therapy GBT EMS Dental Geneve Switzerland using AIRFLOW Prophylaxis Master ultrasonic instruments EMS Dental Geneve Switzerland and Gracey curettes Hu- Friedy Chicago USA Moreover half of the subjects in each group 15 smokers and 15 non-smokers will use a 012 chlorhexidine-digluconate based mouthwash Curasept ADS 212 Curasept SpA Saronno Italy twice a day for one minute during a period of 15 days Subsequently four subgroups of 15 subjects will be formed- non-smokers NS non-smokers who used CHX NS-CHX smokers S and smokers who used CHX S-CHX
All subjects will have non-surgical periodontal therapy carried out according to the principles of Guided biofilm therapy GBT EMS Dental Geneve Switzerland using AIRFLOW Prophylaxis Master ultrasonic instruments EMS Dental Geneve Switzerland and Gracey curettes Hu- Friedy Chicago USA Moreover half of the subjects in each group 15 smokers and 15 non-smokers will use a 012 chlorhexidine-digluconate based mouthwash Curasept ADS 212 Curasept SpA Saronno Italy twice a day for one minute during a period of 15 days Subsequently four subgroups of 15 subjects will be formed- non-smokers NS non-smokers who used CHX NS-CHX smokers S and smokers who used CHX S-CHX
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None