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

NCT ID: NCT07283393

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2035-12-31

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.

Conditions

Periodontal Diseases; Periodontitis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

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

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Periodontal 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy and breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Ghent

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ghent University Hospital

Ghent, East-Flanders, Belgium

Countries

Belgium

Other Identifiers

ONZ-2023-0622

Identifier Type: -

Identifier Source: org_study_id