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Not yet recruiting NCT07753525

The Tooth Collar Technique

No phase Interventional Insufficient Bone Volume Prior to Implant Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tooth Collar Technique.
Who it may be relevant to
Registry conditions: Insufficient Bone Volume Prior to Implant Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Tooth Collar Technique (TCT): a Prospective Case Series on a Novel Flap Design for Ridge Augmentation

Overview

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

  • Procedure Tooth 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.

Primary outcome measures

  • early wound dehiscence [Time frame: within 14 days after augmentation]
  • Early Wound dehiscence [Time frame: within 14 days after augmentation]
  • primary wound healing [Time frame: within 14 days after augmentation]
  • Early Wound dehiscence [Time frame: within 14 days after augmentation]
Secondary outcome measures (7)
  • soft tissue healing quality [Time frame: day 7, 14, 30 and 120 after augmentation]
  • Need for -re-intervantions [Time frame: within 30 days after augmentation]
  • incidence of post-operative infection [Time frame: within 30 days after augmentation]
  • Gingival condition [Time frame: at 4 months after augmentation]
  • Procedural parameters: closure tension [Time frame: immediately after surgery]
  • Procedural parameters: Periosteal release length [Time frame: Immediately after surgery]
  • Procedural parameters: surgical time [Time frame: Intraoperative]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 4 centers
  • ParoPlus Aalst — Aalst
  • Radix Dental — Heist-op-den-Berg
  • Parodontologie & Implantologie Merchtem — Merchtem
  • UZ Leuven — Leuven

Identifiers

NCT: NCT07753525 · S71663

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗