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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2035-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-11-23', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2034-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probing depth', 'timeFrame': 'At 6 months, 1 year, 3 years, 5 years, 7 years and 10 years of follow-up', 'description': 'Probing depth evolution in the short term'}, {'measure': 'Tooth retention', 'timeFrame': 'From enrollment to the end of the study, at 10 years of follow up', 'description': 'Survival of tooth in the long-term follow-up'}], 'secondaryOutcomes': [{'measure': 'Radiographic bone level', 'timeFrame': '6 months, 3 years, 5 years, 7 years and 10 years', 'description': '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)'}, {'measure': 'Tooth mobility', 'timeFrame': 'At 6 months, 1 year, 3 years, 5, 7 and 10 years of follow-up.', 'description': '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.'}, {'measure': 'Bleeding on probing', 'timeFrame': 'At 6 months, 1 year, 3 years, 5, 7 and 10 years of follow-up', 'description': 'Bleeding on probing is assessed using a periodontal probe. A probe is inserted in the pocket and bleeding is noted dichotomously.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Periodontal Diseases', 'Periodontitis']}, 'descriptionModule': {'briefSummary': 'Periodontitis is a common inflammatory disease affecting approximately 40% of the Belgian population.\n\nThe goal of this observational study is to learn about the treatment outcomes of surgical periodontal therapy in adults with periodontitis.\n\nThe main questions this study aims to answer are:\n\n* Does subsequent surgical intervention further improve periodontal health parameters?\n* Is there any significant difference between treatment outcomes of resective and regenerative periodontal surgery.\n\nParticipants will:\n\n\\- Undergo surgical periodontal treatment if residual pocket depth ≥6 mm persists despite good oral hygiene.\n\nStudy inclusion was performed after surgical treatment.\n\n\\- Be screened on various intervals. If there is any recurrent periodontitis, adequate treatment will be performed\n\nIn short term, pocket probing depth is our primary outcome and tooth survival is the outcome in the long term.\n\nSecondary outcomes in short-term are bone level, mobility, bleeding on probing, tooth survival and cost-effectiveness.\n\nLong-term outcomes (\\>5 years) are probing pocket depth, bone level, tooth sensitivity, mobility, bleeding on probing and cost-effectiveness.', 'detailedDescription': "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.\n\nResective or regenerative surgery was performed, based on the bone morphology and the patients characteristics.\n\nInclusion 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.\n\nThe main questions this study aims to answer are:\n\n* Does subsequent surgical intervention further improve periodontal health parameters?\n* Is there any significant difference between treatment outcomes of resective and regenerative periodontal surgery.\n\nPrimary outcomes are pocket probing depth in short-term and tooth survival in the long term.\n\nSecondary outcomes in short-term include bone level, mobility, bleeding on probing, tooth survival and cost-effectiveness.\n\nLong-term outcomes (\\>5 years) are probing pocket depth, bone level, tooth sensitivity, mobility, bleeding on probing and cost-effectiveness."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nDepending 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Min 18 years of age\n* Max 6 months since resective or regenerative periodontal surgery\n* Good general health\n\nExclusion Criteria:\n\n* Pregnancy and breastfeeding'}, 'identificationModule': {'nctId': 'NCT07283393', 'acronym': 'UZFLAPSTUD', 'briefTitle': 'Observational Prospective Study on Resective and Regenerative Periodontal Therapy: Short & Longterm Follow-up', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Observational Prospective Study on Resective and Regenerative Periodontal Therapy: Short & Longterm Follow-up', 'orgStudyIdInfo': {'id': 'ONZ-2023-0622'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Periodontitis patients actively treated with regenerative or resective surgery.', 'description': '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.\n\nThe 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.\n\nThe 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.', 'interventionNames': ['Diagnostic Test: Periodontal charting, peri-apical radiograph and low-dose small-field cone beam CT']}], 'interventions': [{'name': 'Periodontal charting, peri-apical radiograph and low-dose small-field cone beam CT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Clinical measurements through periodontal charting, peri-apical radiography and cone-beam computed tomography. Clinical pictures of the mouth', 'armGroupLabels': ['Periodontitis patients actively treated with regenerative or resective surgery.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'East-Flanders', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Long-term follow up of study. No decision yet.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}