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NCT Number: NCT07283393

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital

Ghent, East-Flanders, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy and breastfeeding

Treatment and study plan

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

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Radiographic bone level

    Time frame: 6 months, 3 years, 5 years, 7 years and 10 years

    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)

  2. Tooth mobility

    Time frame: At 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.

  3. Bleeding on probing

    Time frame: At 6 months, 1 year, 3 years, 5, 7 and 10 years of follow-up

    Bleeding on probing is assessed using a periodontal probe. A probe is inserted in the pocket and bleeding is noted dichotomously.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Acronym: UZFLAPSTUD

Important dates

Study start
2024
Primary completion
2034
Study completion
2035
First posted
Dec 15, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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