The Tooth Collar Technique

NCT07753525 | Not Yet Recruiting

• 1 other identifier: S71663
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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.

Conditions

Insufficient Bone Volume Prior to Implant Surgery

Keywords

Implant surgery; wound dehiscence; Tooth Collar Technique; flap design; ridge augmentation; bone regeneration; wound closure

Outcome Measures

Primary Outcomes (4)

• early wound dehiscence

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

  within 14 days after augmentation

• Early Wound dehiscence

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

  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.)

  within 14 days after augmentation

• Early Wound dehiscence

  Measurement of maximal defect dimension ( in case of wound dehiscence; with periodontal probe; in mm)

  within 14 days after augmentation

Secondary Outcomes (7)

• soft tissue healing quality

  day 7, 14, 30 and 120 after augmentation

• Need for -re-intervantions

  within 30 days after augmentation

• incidence of post-operative infection

  within 30 days after augmentation

• Gingival condition

  at 4 months after augmentation

• Procedural parameters: closure tension

  immediately after surgery

Study Arms (1)

Tooth Collar Technique

EXPERIMENTAL

Participants of the study will receive surgery using the Tooth Collar Technique prior to ridge augmentation.

Procedure: Tooth Collar Technique

Interventions

Tooth Collar Technique PROCEDURE

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.

Also known as: TCTechnique

Tooth Collar Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• 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

Study Sites (4)

ParoPlus Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

Radix Dental

Heist-op-den-Berg, Vlaams Brabant, 2220, Belgium

Location

Parodontologie & Implantologie Merchtem

Merchtem, Vlaams Brabant, 1785, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Study Officials

• Ana B Castro, Professor

  UZLeuven, department of Oral Health Sciences, Periodontology

  PRINCIPAL INVESTIGATOR

• Andy Temmerman, Professor

  ParoPlus Aalst

  PRINCIPAL INVESTIGATOR

• Lorenz Seyssens, Dr

  ParoPlus Aalst

  PRINCIPAL INVESTIGATOR

• Rutger Dhondt, Dr.

  Radix Dental

  PRINCIPAL INVESTIGATOR

• Alexander De Greef, Drs

  Parodontologie & Implantologie Merchtem

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana B Castro Sarda, Professor

CONTACT

+32 16 332816; ana.castro@uzleuven.be

Lieve Desmet, secretary

CONTACT

+32 16 332407; lieve.desmet@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, multicenter, single-arm case series conducted at four clinical centers in Belgium

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)