ComplianceNCT07866664
Association Between Periodontal Status and the Interrupted Supportive Periodontal Therapy During the COVID-19 Pandemic
An observational study of Compliance and Periodontitis, run by University of Zagreb at 1 site in Croatia.
Trial summary
This cross-sectional observational study compared the clinical periodontal status and oral health-related quality of life between patients who continued regular supportive periodontal therapy (SPT) visits during the COVID-19 pandemic and those who experienced a prolonged interruption of SPT. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Compliance, Periodontitis, Periodontal Therapy
- What is being tested?
- Prolonged interruption of supportive periodontal therapy (≥24 months)
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- 7 Jan 2023to 20 Dec 2024
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who had completed active periodontal therapy and were enrolled in a supportive periodontal therapy (SPT) program, divided into those who continued regular SPT visits during the COVID-19 pandemic and those who experienced a prolonged interruption of SPT.
Who may be able to join
- a minimum of 20 teeth in the oral cavity (third molars excluded)
- diagnosed stage III or IV periodontitis according to the 2017 classification
- completed active periodontal therapy two years before the onset of the COVID-19 pandemic
- enrollment in a supportive periodontal therapy program
Who cannot join
- no active periodontal therapy performed before the onset of the pandemic
- use of systemic antibiotics in the last 6 months
- pregnancy
- breastfeeding
- alcohol or drugs abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Periodontal Status and the Prolonged Interruption of Supportive Periodontal Therapy During the COVID-19 Pandemic: A Cross-Sectional Study
This cross-sectional observational study compared the clinical periodontal status and oral health-related quality of life between patients who continued regular supportive periodontal therapy (SPT) visits during the COVID-19 pandemic and those who experienced a prolonged interruption of SPT. The study included patients who had completed active periodontal therapy and were enrolled in an SPT program, divided into a non-compliant group with prolonged SPT interruption and a compliant group with regular SPT. Clinical periodontal parameters including plaque index, bleeding on probing, probing depth, gingival recession, clinical attachment level, and distribution of probing depths were assessed. Oral health-related quality of life was evaluated using the OHIP-14 questionnaire.
- Conditions
- Compliance, Periodontitis, Periodontal Therapy
- Being tested
- Prolonged interruption of supportive periodontal therapy (≥24 months)
- Medical subject headings
- Patient Compliance, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged interruption of supportive periodontal therapy (≥24 months)Other
Observational comparison of patients who experienced a prolonged interruption of supportive periodontal therapy during the COVID-19 pandemic versus those who continued regular SPT visits. No treatment is assigned by the investigator; participants are observed based on their existing SPT compliance status.
| Study group | Role | What they receive |
|---|---|---|
| Compliant | Not described | |
| Non-compliant | Not described Receives: Other: Prolonged interruption of supportive periodontal therapy (≥24 months) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPD
Periodontal probing depth - the distance in millimeters from the gingival margin to the base of the periodontal pocket. It is measured using a standard periodontal probe at 6 sites per tooth. Higher values indicate deeper periodontal pockets (worse periodontal status), while lower values indicate shallower pockets (better periodontal status).
Measured: Baseline (single assessment)
Secondary outcomes (1)
OHIP-14
OHIP-14 is a 14-item questionnaire that assesses the impact of oral health on oral health-related quality of life. Each item is scored on a Likert scale from 0 to 4 (0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often). The total score ranges from 0 to 56. Higher scores indicate worse oral health-related quality of life, while lower scores indicate better oral health-related quality of life.
Measured: Baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start7 Jan 2023
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplianceStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivana Bradvica, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866664
- Sponsor's protocol ID
- 05-PA-30-18-5/2023
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Periodontal Status and the Prolonged Interruption of Supportive Periodontal Therapy During the COVID-19 Pandemic: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07866664
- Acronym / sponsor ID
- 05-PA-30-18-5/2023
- Conditions
- Compliance, Periodontitis, Periodontal Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 8 Oct 2026 (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.
This cross-sectional observational study compared the clinical periodontal status and oral health-related quality of life between patients who continued regular supportive periodontal therapy (SPT) visits during the COVID-19 pandemic and those who experienced a prolonged interruption of SPT. The study included patients who had completed active periodontal therapy and were enrolled in an SPT program, divided into a non-compliant group with prolonged SPT interruption and a compliant group with regular SPT. Clinical periodontal parameters including plaque index, bleeding on probing, probing depth, gingival recession, clinical attachment level, and distribution of probing depths were assessed. Oral health-related quality of life was evaluated using the OHIP-14 questionnaire.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compliant | – | – |
| Non-compliant | – | Other: Prolonged interruption of supportive periodontal therapy (≥24 months) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had completed active periodontal therapy and were enrolled in a supportive periodontal therapy (SPT) program, divided into those who continued regular SPT visits during the COVID-19 pandemic and those who experienced a prolonged interruption of SPT.
Key inclusion criteria (4 listed)
- a minimum of 20 teeth in the oral cavity (third molars excluded)
- diagnosed stage III or IV periodontitis according to the 2017 classification
- completed active periodontal therapy two years before the onset of the COVID-19 pandemic
- enrollment in a supportive periodontal therapy program
Key exclusion criteria (5 listed)
- no active periodontal therapy performed before the onset of the pandemic
- use of systemic antibiotics in the last 6 months
- pregnancy
- breastfeeding
- alcohol or drugs abuse
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 |
|---|---|---|
| Prolonged interruption of supportive periodontal therapy (≥24 months)Observational comparison of patients who experienced a prolonged interruption of supportive periodontal therapy during the COVID-19 pandemic versus those who continued regular SPT visits. No treatment is assigned by the investigator; participants are observed based on their existing SPT compliance status. | Other | Non-compliant |
Primary outcome
PPD
Time frame: Baseline (single assessment)
Periodontal probing depth - the distance in millimeters from the gingival margin to the base of the periodontal pocket. It is measured using a standard periodontal probe at 6 sites per tooth. Higher values indicate deeper periodontal pockets (worse periodontal status), while lower values indicate shallower pockets (better periodontal status).
1 secondary outcome
OHIP-14
Time frame: Baseline (single assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compliance and Periodontitis, run by University of Zagreb 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 8 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPD (time frame: Baseline (single assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.