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NCT07753525
The Tooth Collar Technique
Conditions: Insufficient Bone Volume Prior to Implant Surgery
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Universitaire Ziekenhuizen KU Leuven
Location: ParoPlus Aalst Aalst Oost-Vlaanderen
Summary
The aim of this study is to evaluate wound healing after the application of the Tooth Collar Technique (TCT) for bone augmentation in the upper or lower jaw. This technique is designed to promote tension-free wound closure and to reduce the risk of wound dehiscence. Augmentation is performed under local anesthesia. The gingiva is opened according to the TCT, after which the bone defect is reconstructed with standard biomaterials and covered with a membrane. No experimental materials are used- only a modified incision technique.
Eligibility Criteria
Inclusion Criteria:
* Voluntary written informed consent of the participant or their legal authorized representative has been obtained prior to any screening procedures
* At least 18 years of age at the time of signing the Informed Consent Form (ICF)
* Indication for horizontal and/or vertical bone augmentation in the maxilla or mandible in preparation for implant placement
* Sufficient general health to undergo elective oral surgical procedures, as judgjed by the investigator
* Ability and willingness to attend all study visits and comply with the protocol requirements.
Exclusion Criteria:
* Current smoking or use of other nicotine-containing products (eg, e-cigarettes, chewing tobacco)
* Presence of uncontrolled systemic diseases that may compromise healing
* Ongoing chemotherapy, radiotherapy, or bisposphonate/anti-resorptive therapy in the head or neck region
* History of radiation therapy to the jaws
* active or untreated periodontal disease, caries or poor oral hygiene
* Poorly fitting restorations on teeth adjacent to the augmentation site
* Known allergy or hypersensitivity to any material used in the augmentation procedure.
* Pregnant or breastfeeding women, or women planning pregnancy during the study period.
* Participation in another interventional clinical study within the last 30 days
* Any other condition or circumstance that, in the opinion of the investigator, could compromise participant safety, compliance, or the validity of the study results.
* Participation in an interventional study with an investigational medicinal product or device.
Source: ClinicalTrials.gov (NCT07753525). StuddyBuddy aggregates publicly available trial information.