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

Not Applicable

Recruiting

• Conditions: Periodontitis
• Interventions: Procedure: Initial periodontal therapy and 3D intraoral scanning

• Registration Number: NCT05719519
• Lead Sponsor: University of Rijeka

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-25
• Study Start: 2023-02-01
• Study First Submitted QC: 2023-02-07
• Study First Posted: 2023-02-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-29
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smokers	Initial periodontal therapy and 3D intraoral scanning	-
Non smokers	Initial periodontal therapy and 3D intraoral scanning	-

Primary Outcome Measures

Name	Time	Method
Volume changes	24 months	soft tissue volume changes after therapy ( mm3)

Trial Locations

Locations (1)

Faculty of Dental Medicine; 🇭🇷 Rijeka, Croatia