Periodontal DiseasesUZFLAPSTUDNCT07283393
Observational Prospective Study on Resective and Regenerative Periodontal Therapy: Short & Longterm Follow-up
An observational study of Periodontal Diseases and Periodontitis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Periodontitis is a common inflammatory disease affecting approximately 40% of the Belgian population. The goal of this observational study is to learn about the treatment outcomes of surgical periodontal therapy in adults with periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Diseases, Periodontitis
- What is being tested?
- Periodontal charting, peri-apical radiograph and low-dose small-field cone beam CT
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2024to 31 Dec 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: All patients aged at least 18 years old have been treated for periodontitis through subgingival debridement. During re-evaluation, remaining pockets were found despite adequate oral hygiene. Depending on the anatomy of the defect, resective or regenerative surgery was performed. Patients were included if resective or regenerative periodontal surgery was performed < 6months ago and an informed consent was signed.
Who may be able to join
- Min 18 years of age
- Max 6 months since resective or regenerative periodontal surgery
- Good general health
Who cannot join
- Pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Periodontitis is a common inflammatory disease affecting approximately 40% of the Belgian population.
The goal of this observational study is to learn about the treatment outcomes of surgical periodontal therapy in adults with periodontitis.
Read more
The main questions this study aims to answer are:
- Does subsequent surgical intervention further improve periodontal health parameters?
- Is there any significant difference between treatment outcomes of resective and regenerative periodontal surgery.
Participants will:
- Undergo surgical periodontal treatment if residual pocket depth ≥6 mm persists despite good oral hygiene.
Study inclusion was performed after surgical treatment.
- Be screened on various intervals. If there is any recurrent periodontitis, adequate treatment will be performed
In short term, pocket probing depth is our primary outcome and tooth survival is the outcome in the long term.
Secondary outcomes in short-term are bone level, mobility, bleeding on probing, tooth survival and cost-effectiveness.
Long-term outcomes (>5 years) are probing pocket depth, bone level, tooth sensitivity, mobility, bleeding on probing and cost-effectiveness.
Read the detailed description
Periodontitis is a common condition, affecting approximately 40% of the Belgian populations. The condition most common characteristics are bleeding of the gingiva and bone loss. Left untreated, this disease can lead to severe loss of maxillary or mandibulary bone. Treatment for primary stages of periodontitis don't always require surgical interventions; correction of oral hygiene and deep cleaning the teeth combined, if necessary, with extraction of irrational to treat elements under local anesthesia can be sufficient. Three months after initial treatment, at the re-evaluation, the depth of the tooth pockets, bleeding on probing, mobility and the amount of regression of the gums are reassessed. If the depth of the tooth pockets regressed insuffient, with a depth of at least six milimeters, eventhough the patients oral hygiene is acceptable, further surgical treatment is necessary. A patient is not able to clean these greater pockets.
Resective or regenerative surgery was performed, based on the bone morphology and the patients characteristics.
Inclusion of patients in this study was performed after surgical treatment. Research parameters will be evaluated at 6 months, 1 year, 3 years, 5 years, 7 and 10 years after surgery.
The main questions this study aims to answer are:
- Does subsequent surgical intervention further improve periodontal health parameters?
- Is there any significant difference between treatment outcomes of resective and regenerative periodontal surgery.
Primary outcomes are pocket probing depth in short-term and tooth survival in the long term.
Secondary outcomes in short-term include bone level, mobility, bleeding on probing, tooth survival and cost-effectiveness.
Long-term outcomes (>5 years) are probing pocket depth, bone level, tooth sensitivity, mobility, bleeding on probing and cost-effectiveness.
- Conditions
- Periodontal Diseases, Periodontitis
- Being tested
- Periodontal charting, peri-apical radiograph and low-dose small-field cone beam CT
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal charting, peri-apical radiograph and low-dose small-field cone beam CTDiagnostic test
Clinical measurements through periodontal charting, peri-apical radiography and cone-beam computed tomography. Clinical pictures of the mouth
| Study group | Role | What they receive |
|---|---|---|
| Periodontitis patients actively treated with regenerative or resective surgery. | Periodontitis patients actively treated with regenerative or resective surgery. The study commences only after the patient has undergone either a regenerative or resective periodontal surgery; the surgical procedure itself is not part of the investigation.
The objective of the study is to monitor and compare both treatment modalities in the short and long term with respect to tooth survival, bone level, probing pocket depth, tooth sensitivity, mobility, bleeding on probing, and cost-effectiveness.
The dental patient records will be reviewed to obtain available data from before and during the surgical procedure, including general patient information (age, sex, ASA classification, and medication), periodontal status, radiographic documentation, and clinical photographs. Receives: Diagnostic Test: Periodontal charting, peri-apical radiograph and low-dose small-field cone beam CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
Probing depth evolution in the short term
Measured: At 6 months, 1 year, 3 years, 5 years, 7 years and 10 years of follow-up
Tooth retention
Survival of tooth in the long-term follow-up
Measured: From enrollment to the end of the study, at 10 years of follow up
Secondary outcomes (3)
Radiographic bone level
A peri-apical radiograph will be taken at various recall appointments. Bone level will be measured using ImageJ software. Calibration will be performed using an orthodontic button, with known dimensions. Two measurements will be made; cemento-enamel junction to the bottom of the pocket and the infra-bony component (alveolar crest to bottom of pocket)
Measured: 6 months, 3 years, 5 years, 7 years and 10 years
Tooth mobility
Mobility of the tooth is assessed using the Miller Classification (1958). Grade 1 is horizontal mobility <1mm, grade 2 is >2mm and grade 3 is horizontal + vertical mobility.
Measured: At 6 months, 1 year, 3 years, 5, 7 and 10 years of follow-up.
Bleeding on probing
Bleeding on probing is assessed using a periodontal probe. A probe is inserted in the pocket and bleeding is noted dichotomously.
Measured: At 6 months, 1 year, 3 years, 5, 7 and 10 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283393
- Sponsor's protocol ID
- ONZ-2023-0622
- Acronym
- UZFLAPSTUD
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Long-term follow up of study. No decision yet.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Prospective Study on Resective and Regenerative Periodontal Therapy: Short & Longterm Follow-up
- ClinicalTrials.gov ID
- NCT07283393
- Acronym / sponsor ID
- UZFLAPSTUD / ONZ-2023-0622
- Conditions
- Periodontal Diseases, Periodontitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 15 Dec 2025 (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.
Periodontitis is a common inflammatory disease affecting approximately 40% of the Belgian population.
The goal of this observational study is to learn about the treatment outcomes of surgical periodontal therapy in adults with periodontitis.
The main questions this study aims to answer are:
- Does subsequent surgical intervention further improve periodontal health parameters?
- Is there any significant difference between treatment outcomes of resective and regenerative periodontal surgery.
Participants will:
- Undergo surgical periodontal treatment if residual pocket depth ≥6 mm persists despite good oral hygiene.
Study inclusion was performed after surgical treatment.
- Be screened on various intervals. If there is any recurrent periodontitis, adequate treatment will be performed
In short term, pocket probing depth is our primary outcome and tooth survival is the outcome in the long term.
Secondary outcomes in short-term are bone level, mobility, bleeding on probing, tooth survival and cost-effectiveness.
Long-term outcomes (>5 years) are probing pocket depth, bone level, tooth sensitivity, mobility, bleeding on probing and cost-effectiveness.
Detailed description
Periodontitis is a common condition, affecting approximately 40% of the Belgian populations. The condition most common characteristics are bleeding of the gingiva and bone loss. Left untreated, this disease can lead to severe loss of maxillary or mandibulary bone. Treatment for primary stages of periodontitis don't always require surgical interventions; correction of oral hygiene and deep cleaning the teeth combined, if necessary, with extraction of irrational to treat elements under local anesthesia can be sufficient. Three months after initial treatment, at the re-evaluation, the depth of the tooth pockets, bleeding on probing, mobility and the amount of regression of the gums are reassessed. If the depth of the tooth pockets regressed insuffient, with a depth of at least six milimeters, eventhough the patients oral hygiene is acceptable, further surgical treatment is necessary. A patient is not able to clean these greater pockets.
Resective or regenerative surgery was performed, based on the bone morphology and the patients characteristics.
Inclusion of patients in this study was performed after surgical treatment. Research parameters will be evaluated at 6 months, 1 year, 3 years, 5 years, 7 and 10 years after surgery.
The main questions this study aims to answer are:
- Does subsequent surgical intervention further improve periodontal health parameters?
- Is there any significant difference between treatment outcomes of resective and regenerative periodontal surgery.
Primary outcomes are pocket probing depth in short-term and tooth survival in the long term.
Secondary outcomes in short-term include bone level, mobility, bleeding on probing, tooth survival and cost-effectiveness.
Long-term outcomes (>5 years) are probing pocket depth, bone level, tooth sensitivity, mobility, bleeding on probing and cost-effectiveness.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Periodontitis patients actively treated with regenerative or resective surgery. | – | Diagnostic Test: Periodontal charting, peri-apical radiograph and low-dose small-field cone beam CTPeriodontitis patients actively treated with regenerative or resective surgery. The study commences only after the patient has undergone either a regenerative or resective periodontal surgery; the surgical procedure itself is not part of the investigation. The objective of the study is to monitor and compare both treatment modalities in the short and long term with respect to tooth survival, bone level, probing pocket depth, tooth sensitivity, mobility, bleeding on probing, and cost-effectiveness. The dental patient records will be reviewed to obtain available data from before and during the surgical procedure, including general patient information (age, sex, ASA classification, and medication), periodontal status, radiographic documentation, and clinical photographs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged at least 18 years old have been treated for periodontitis through subgingival debridement. During re-evaluation, remaining pockets were found despite adequate oral hygiene. Depending on the anatomy of the defect, resective or regenerative surgery was performed. Patients were included if resective or regenerative periodontal surgery was performed < 6months ago and an informed consent was signed.
Key inclusion criteria (3 listed)
- Min 18 years of age
- Max 6 months since resective or regenerative periodontal surgery
- Good general health
Key exclusion criteria (1 listed)
- Pregnancy and breastfeeding
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 |
|---|---|---|
| Periodontal charting, peri-apical radiograph and low-dose small-field cone beam CTClinical measurements through periodontal charting, peri-apical radiography and cone-beam computed tomography. Clinical pictures of the mouth | Diagnostic test | Periodontitis patients actively treated with regenerative or resective surgery. |
Primary outcome
Probing depth
Time frame: At 6 months, 1 year, 3 years, 5 years, 7 years and 10 years of follow-up
Probing depth evolution in the short term
Tooth retention
Time frame: From enrollment to the end of the study, at 10 years of follow up
Survival of tooth in the long-term follow-up
3 secondary outcomes
Radiographic bone level
Time frame: 6 months, 3 years, 5 years, 7 years and 10 years
Tooth mobility
Time frame: At 6 months, 1 year, 3 years, 5, 7 and 10 years of follow-up.
Bleeding on probing
Time frame: At 6 months, 1 year, 3 years, 5, 7 and 10 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: Undecided. Long-term follow up of study. No decision yet.
Related trials for Periodontal Diseases
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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 Periodontal Diseases and Periodontitis, run by University Hospital, Ghent at 1 site in Belgium.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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?
Probing depth (time frame: At 6 months, 1 year, 3 years, 5 years, 7 years and 10 years of follow-up). The study lists 2 primary outcomes in all. 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 15 Dec 2025.