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Observational Prospective Study on Resective and Regenerative Periodontal Therapy: Short & Longterm Follow-up

Observational Prospective Study on Resective and Regenerative Periodontal Therapy: Short & Longterm Follow-up

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07283393
Acronym
UZFLAPSTUD
Enrollment
30
Registered
2025-12-15
Start date
2024-01-01
Completion date
2035-12-31
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases, Periodontitis

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTPeriodontal charting, peri-apical radiograph and low-dose small-field cone beam CT

Clinical measurements through periodontal charting, peri-apical radiography and cone-beam computed tomography. Clinical pictures of the mouth

Sponsors

University Ghent
CollaboratorOTHER
University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Min 18 years of age * Max 6 months since resective or regenerative periodontal surgery * Good general health

Exclusion criteria

* Pregnancy and breastfeeding

Design outcomes

Primary

MeasureTime frameDescription
Probing depthAt 6 months, 1 year, 3 years, 5 years, 7 years and 10 years of follow-upProbing depth evolution in the short term
Tooth retentionFrom enrollment to the end of the study, at 10 years of follow upSurvival of tooth in the long-term follow-up

Secondary

MeasureTime frameDescription
Radiographic bone level6 months, 3 years, 5 years, 7 years and 10 yearsA 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)
Tooth mobilityAt 6 months, 1 year, 3 years, 5, 7 and 10 years of follow-up.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.
Bleeding on probingAt 6 months, 1 year, 3 years, 5, 7 and 10 years of follow-upBleeding on probing is assessed using a periodontal probe. A probe is inserted in the pocket and bleeding is noted dichotomously.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026