The Effect of Smoking and Chlorhexidine on Periodontal Tissues After Non- Surgical Periodontal Therapy in Patients With Periodontitis

NCT06191497 | Unknown

• 1 other identifier: CHX 01/22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 0.12% chlorhexidine based mouth rinse twice a day during 15 days. Clinical examination will be repeated 8 weeks after NSPT and compared.

Conditions

Smoking; Periodontitis; Periodontal Diseases

Outcome Measures

Primary Outcomes (6)

• Full mouth plaque score

  plaque accumulation

  8 weeks

• Full mouth bleeding score

  gingival bleeding

  8 weeks

• Pocket depth

  periodontal pocket depth in mm

  8 weeks

• Clinical attachment level

  clinical attachment loss in mm

  8 weeks

• Gingival recession

  gingival recession in mm

  8 weeks

• Tooth mobility

  tooth mobility- Miller class

  8 weeks

Study Arms (4)

Non-smokers

ACTIVE COMPARATOR

15 non-smoking subjects with diagnosed periodontitis. All of them underwent NSPT

Procedure: non surgical periodontal therapy

Non-smokers+ CHX

EXPERIMENTAL

15 non-smoking subjects with diagnosed periodontitis. All of them underwent NSPT and used 0.12% chlorhexidine mouthwash for 15 days after therapy

Procedure: non surgical periodontal therapy; Drug: Chlorhexidine mouthwash

Smokers

ACTIVE COMPARATOR

15 cigarette smoking subjects with diagnosed periodontitis. All of them underwent NSPT

Procedure: non surgical periodontal therapy

Smokers + CHX

EXPERIMENTAL

15 cigarette smoking subjects with diagnosed periodontitis. All of them underwent NSPT and used 0.12% chlorhexidine mouthwash for 15 days after therapy

Procedure: non surgical periodontal therapy; Drug: Chlorhexidine mouthwash

Interventions

non surgical periodontal therapy PROCEDURE

NSPT based on Guided biofilm therapy principle (EMS Dental, Switzerland)

Non-smokers; Non-smokers+ CHX; Smokers; Smokers + CHX

Chlorhexidine mouthwash DRUG

0.12% chlorhexidine based mouthwash used twice a day for 15 days after therapy

Non-smokers+ CHX; Smokers + CHX

Eligibility Criteria

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

You may qualify if:

• patients with periodontitis smokers and non smokers.

You may not qualify if:

• 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
• Patients smoking e-cigarettes, tobacco heating systems, cigarettes without filter and occasional smokers

Sponsors & Collaborators

• University of Rijeka: lead

Study Sites (1)

Faculty of dental medicine

Rijeka, 51000, Croatia

Location

MeSH Terms

Conditions

Smoking; Periodontitis; Periodontal Diseases

Condition Hierarchy (Ancestors)

Behavior; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant, Department of Periodontology

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: March 14, 2022
• Primary Completion: October 16, 2023
• Study Completion: May 1, 2024
• Last Updated: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)