Insufficient Bone Volume Prior to Implant Surgery
Conditions
Keywords
Implant surgery, wound dehiscence, Tooth Collar Technique, flap design, ridge augmentation, bone regeneration, wound closure
Brief 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.
Detailed description
The purpose of this study is to evaluate the clinical performance and feasibility of the Tooth Collar Technique, a novel flap design for horizontal and vertical bone augmentation, in terms of early wound healing and surgical outcomes. Published studies on horizontal and vertical bone augmentation report early wound dehiscence or exposure rates typically in the 15-30% range, with higher values for complex vertical procedures and non-resorbable barriers. Therefore, 20% is set as the Objective Performance Criterion for early wound dehiscence.
Interventions
PROCEDURETooth Collar Technique
During surgery, the gingiva will be opened using tooth collar technique instead of standard flap designs; after which the bone defect is augmented using standard biomaterials and covered with a membrane.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Paro Plus Aalst (https://paroplus.be/; private practice contracted by UZ Leuven)
Radix (https://radix-dental.be/); Privcate practice contracted by UZ Leuven)
Paro Merchtem (https://paromerchtem.be/; private practice contracted by UZ Leuven)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, multicenter, single-arm case series conducted at four clinical centers in Belgium
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| early wound dehiscence | within 14 days after augmentation | Incidence of early wound dehiscence (yes/no) at the crest of the surgical site |
| Early Wound dehiscence | within 14 days after augmentation | Documentation of location of wound dehiscence (if there is wound dehiscence) with clinical photo |
| primary wound healing | within 14 days after augmentation | quality of primary wound healing using Wound Healing Index (WHI) of PMID16253095 ( score 1 = uneventful healing with nogingival edema, erythema, suppuration, patient dis-comfort, or flap dehiscence; score 2 = uneventfulhealing with slight gingival edema, erythema, patientdiscomfort, or flap dehiscence, but no suppuration;and score 3 = poor wound healing with significantgingival edema, erythema, patient discomfort, flapdehiscence, or any suppuration.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| soft tissue healing quality | day 7, 14, 30 and 120 after augmentation | assess soft tissue healing quality using the Early Wound Healing Score (EHS); maximum of 10 points; cfr PMID31480586 |
| Need for -re-intervantions | within 30 days after augmentation | To monitor the need for re-interventions (yes/no) |
| incidence of post-operative infection | within 30 days after augmentation | Post-operative infection (yes/no; criteria: clinical diagnosis and/or need for systemic antibiotics) |
| Gingival condition | at 4 months after augmentation | Presence of recession or scarring |
| Procedural parameters: closure tension | immediately after surgery | Feasibility/procedural parameters: closure tension (yes/no) |
| Procedural parameters: Periosteal release length | Immediately after surgery | periosteal release length (mm) |
| Procedural parameters: surgical time | Intraoperative | total surgical time (s) |
Countries
Belgium
Contacts
CONTACTAna B Castro Sarda, Professor
CONTACTLieve Desmet, secretary
PRINCIPAL_INVESTIGATORAna B Castro, Professor
UZLeuven, department of Oral Health Sciences, Periodontology
PRINCIPAL_INVESTIGATORAndy Temmerman, Professor
ParoPlus Aalst
PRINCIPAL_INVESTIGATORLorenz Seyssens, Dr
ParoPlus Aalst
PRINCIPAL_INVESTIGATORRutger Dhondt, Dr.
Radix Dental
PRINCIPAL_INVESTIGATORAlexander De Greef, Drs
Parodontologie & Implantologie Merchtem
Outcome results
None listed