Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:37 PM
Study NCT ID:
NCT07283393
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Prospective Study on Resective and Regenerative Periodontal Therapy: Short & Longterm Follow-up
Sponsor:
University Hospital, Ghent
Organization:
Study Overview
Official Title:
Observational Prospective Study on Resective and Regenerative Periodontal Therapy: Short & Longterm Follow-up
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UZFLAPSTUD
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: