PeriodontitisNCT05719519
Change in Gingival Volume and Quality of Life Due to Initial Periodontal Therapy in Smokers
A study testing Initial periodontal therapy and 3D intraoral scanning in people with Periodontitis, run by University of Rijeka at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Initial periodontal therapy and 3D intraoral scanning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Feb 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- periodontitis
- cigarette smokers
- non smokers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Faculty of Dental Medicine
Rijeka, 51000
Aleksandar Pupovac, DMD, +385 51 345 641, aleksandar.pupovac@fdmri.uniri.hr
About this study
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.
- Conditions
- Periodontitis
- Being tested
- Initial periodontal therapy and 3D intraoral scanning
- Keywords
- 3D imaging, gingiva, nonsurgical periodontal debridement, periodontitis, quality of life, smoking
- Medical subject headings
- Periodontitis, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial periodontal therapy and 3D intraoral scanningProcedure or surgery
Initial periodontal therapy using GBT ( guided biofilm therapy) principle and 3D intraoral scanning
| Study group | Role | What they receive |
|---|---|---|
| Smokers | Other | Not described Receives: Procedure: Initial periodontal therapy and 3D intraoral scanning |
| Non smokers | Experimental | Not described Receives: Procedure: Initial periodontal therapy and 3D intraoral scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume changes
soft tissue volume changes after therapy ( mm3)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rijeka
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandar Pupovac, University of Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719519
- Sponsor's protocol ID
- 08-21
- Status last verified
- Nov 2023
- First submitted
- 25 Jan 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40234017
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Gingival Volume and Quality of Life Due to Initial Periodontal Therapy in Smokers
- ClinicalTrials.gov ID
- NCT05719519
- Acronym / sponsor ID
- 08-21
- Conditions
- Periodontitis
- Keywords
- 3D imaging, gingiva, nonsurgical periodontal debridement, periodontitis, quality of life, smoking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of RijekaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smokers | Other | Procedure: Initial periodontal therapy and 3D intraoral scanning |
| Non smokers | Experimental | Procedure: Initial periodontal therapy and 3D intraoral scanning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- periodontitis
- cigarette smokers
- non smokers
Key exclusion criteria (8 listed)
- previous periodontal treatment
- pregnancy
- minors
- antibiotic therapy in the last 6 months
- patients with ortho appliances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial periodontal therapy and 3D intraoral scanningInitial periodontal therapy using GBT ( guided biofilm therapy) principle and 3D intraoral scanning | Procedure or surgery | Non smokers, Smokers |
Primary outcome
Volume changes
Time frame: 24 months
soft tissue volume changes after therapy ( mm3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 40234017Pupovac 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial periodontal therapy and 3D intraoral scanning in people with Periodontitis, run by University of Rijeka at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksandar Pupovac, DMD (00385 51 345 641, aleksandar.pupovac@fdmri.uniri.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume changes (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05719519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.