Health TrialsbyHealthPanel

The Tooth Collar Technique

ConditionInsufficient Bone Volume Prior to Implant Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Tooth Collar Technique

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Tooth Collar TechniqueExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

early wound dehiscence

Incidence of early wound dehiscence (yes/no) at the crest of the surgical site

Time frame
within 14 days after augmentation
2

Early Wound dehiscence

Documentation of location of wound dehiscence (if there is wound dehiscence) with clinical photo

Time frame
within 14 days after augmentation
3

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
4

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

Secondary outcomes

1

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
2

Need for -re-intervantions

To monitor the need for re-interventions (yes/no)

Time frame
within 30 days after augmentation
3

incidence of post-operative infection

Post-operative infection (yes/no; criteria: clinical diagnosis and/or need for systemic antibiotics)

Time frame
within 30 days after augmentation
4

Gingival condition

Presence of recession or scarring

Time frame
at 4 months after augmentation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Paro Plus Aalst (https://paroplus.be/; private practice contracted by UZ Leuven)

Collaborator

Radix (https://radix-dental.be/); Privcate practice contracted by UZ Leuven)

Collaborator

Paro Merchtem (https://paromerchtem.be/; private practice contracted by UZ Leuven)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: