Change in Gingival Volume and Quality of Life Due to Initial Periodontal Therapy in Smokers

Periodontitis Clinical Trial

Official title:

Change in Gingival Volume and Quality of Life Due to Initial Periodontal Therapy in Smokers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05719519
• Other study ID #: 08-21
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Rijeka
• Contact: Aleksandar Pupovac, DMD
• Phone: 00385 51 345 641
• Email: aleksandar.pupovac[@]fdmri.uniri.hr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the dimensional changes of the gingiva due to initial periodontal therapy in non-smokers and cigarette smokers and to compare the oral health related quality of life of non-smokers and cigarette smokers with periodontitis before and after initial periodontal therapy. Changes in gingival volume are expected to be greater in non-smokers than in cigarette smokers. It is expected that the quality of life will be better after therapy in both groups, with better results in the non-smoking group.

60 subjects with periodontitis will be included in the study 30 non-smokers and 30 cigarette smokers. All subjects will fill out a quality of life questionnaire which will be validated before the onset of this research. This will be followed by clinical periodontal examination. After examination, the upper and lower jaw will be scanned using an intraoral scanner and initial periodontal therapy will be performed. After 8 weeks, subjects will fill out the quality of life questionnaire again, measurement of periodontal indices and scanning will be performed. The digital scans wll be superimposed, and the dimensional changes of the gingiva will be quantified and compared between the two groups. By using 3D technology, it will be possible to objectively quantify tissue changes and monitor the course of the disease. A 3D comparison between non-smokers and cigarette smokers will provide a new perspective on the relationship between smoking and periodontitis. Furthermore, it will be demonstrated to what extent smoking affects the quality of life of patients with periodontitis and the results of non-surgical therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• periodontitis

• cigarette smokers

• non smokers

Exclusion Criteria:

• previous periodontal treatment

• pregnancy

• minors

• antibiotic therapy in the last 6 months

• patients with ortho appliances

• patients using drugs that affect gingival volume

• immunosuppressive therapy

• systemic conditions that affects periodontal tissues and therapy

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Initial periodontal therapy and 3D intraoral scanning
Initial periodontal therapy using GBT ( guided biofilm therapy) principle and 3D intraoral scanning

Locations

Country	Name	City	State
Croatia	Faculty of Dental Medicine	Rijeka

Sponsors (1)

Lead Sponsor	Collaborator
University of Rijeka

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume changes	soft tissue volume changes after therapy ( mm3)	24 months