NCT05719519

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

January 25, 2023

Last Update Submit

November 23, 2023

Conditions

Periodontitis

Keywords

3D imaginggingivanonsurgical periodontal debridementperiodontitisquality of lifesmoking

Outcome Measures

Primary Outcomes (1)

  • Volume changes

    soft tissue volume changes after therapy ( mm3)

    24 months

Study Arms (2)

Smokers

OTHER
Procedure: Initial periodontal therapy and 3D intraoral scanning

Non smokers

EXPERIMENTAL
Procedure: Initial periodontal therapy and 3D intraoral scanning

Interventions

Initial periodontal therapy and 3D intraoral scanningPROCEDURE

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

Non smokersSmokers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • periodontitis
  • cigarette smokers
  • non smokers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine

Rijeka, 51000, Croatia

RECRUITING

Related Publications (1)

  • Pupovac A, Kuis D, Miskovic I, Spalj S, Zhurov A, Prpic J. A New Method for Volumetric Analysis of Soft-Tissue Changes Using Three-Dimensional Imaging in Patients With Periodontitis. J Clin Periodontol. 2025 Jun;52(6):888-897. doi: 10.1111/jcpe.14118. Epub 2025 Apr 15.

    PMID: 40234017DERIVED

MeSH Terms

Conditions

PeriodontitisSmoking

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBehavior

Central Study Contacts

Aleksandar Pupovac, DMD

CONTACT

00385 51 345 641aleksandar.pupovac@fdmri.uniri.hr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant, Department of periodontology

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 9, 2023

Study Start

February 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)