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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
ParoPlus Aalst
Aalst, Oost-Vlaanderen, Belgium
Radix Dental
Heist-op-den-Berg, Vlaams Brabant, Belgium
Parodontologie & Implantologie Merchtem
Merchtem, Vlaams Brabant, Belgium
UZ Leuven
Leuven, Belgium
early wound dehiscence
Incidence of early wound dehiscence (yes/no) at the crest of the surgical site
Time frame: within 14 days after augmentation
Early Wound dehiscence
Documentation of location of wound dehiscence (if there is wound dehiscence) with clinical photo
Time frame: within 14 days after augmentation
primary wound healing
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.)
Time frame: within 14 days after augmentation
Early Wound dehiscence
Measurement of maximal defect dimension ( in case of wound dehiscence; with periodontal probe; in mm)
Time frame: within 14 days after augmentation
soft tissue healing quality
assess soft tissue healing quality using the Early Wound Healing Score (EHS); maximum of 10 points; cfr PMID31480586
Time frame: day 7, 14, 30 and 120 after augmentation
Need for -re-intervantions
To monitor the need for re-interventions (yes/no)
Time frame: within 30 days after augmentation
incidence of post-operative infection
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Post-operative infection (yes/no; criteria: clinical diagnosis and/or need for systemic antibiotics)
Time frame: within 30 days after augmentation
Gingival condition
Presence of recession or scarring
Time frame: at 4 months after augmentation
Procedural parameters: closure tension
Feasibility/procedural parameters: closure tension (yes/no)
Time frame: immediately after surgery
Procedural parameters: Periosteal release length
periosteal release length (mm)
Time frame: Immediately after surgery
Procedural parameters: surgical time
total surgical time (s)
Time frame: Intraoperative