Insufficient Bone Volume Prior to Implant SurgeryTCTechniqueNCT07753525
The Tooth Collar Technique
A study testing Tooth Collar Technique in people with Insufficient Bone Volume Prior to Implant Surgery, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insufficient Bone Volume Prior to Implant Surgery
- What is being tested?
- Tooth Collar Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesBelgium
- Study dates
- Sep 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium4 sites
ParoPlus Aalst
Aalst, Oost-Vlaanderen, 9300
Andy Temmerman, Professor, +32 53 71 06 08, andy.temmerman@kuleuven.be
Lorenz Seyssens, Dr
Radix Dental
Heist-op-den-Berg, Vlaams Brabant, 2220
Rutger Dhondt, Dr, +32 3 500 22 21, rutgerdhondt@hotmail.com
UZ Leuven
Leuven, 3000
Ana Castro, Drs, +32 16 37 37 48, anabelen.castrosarda@kuleuven.be
Lieve Desmet, secretary, +32 16 332407, lieve.desmet@kuleuven.be
Parodontologie & Implantologie Merchtem
Merchtem, Vlaams Brabant, 1785
Alexander De Greef, Drs, alexanderdegreef@hotmail.com
About this study
Official title: The Tooth Collar Technique (TCT): a Prospective Case Series on a Novel Flap Design for Ridge Augmentation
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.
Read the 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.
- Being tested
- Tooth Collar Technique
- Keywords
- Implant surgery, wound dehiscence, Tooth Collar Technique, flap design, ridge augmentation, bone regeneration, wound closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth Collar TechniqueProcedure or surgery
Also called TCTechnique
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.
| Study group | Role | What they receive |
|---|---|---|
| Tooth Collar Technique | Experimental | Participants of the study will receive surgery using the Tooth Collar Technique prior to ridge augmentation. Receives: Procedure: Tooth Collar Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
early wound dehiscence
Incidence of early wound dehiscence (yes/no) at the crest of the surgical site
Measured: within 14 days after augmentation
Early Wound dehiscence
Documentation of location of wound dehiscence (if there is wound dehiscence) with clinical photo
Measured: 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.)
Measured: within 14 days after augmentation
Early Wound dehiscence
Measurement of maximal defect dimension ( in case of wound dehiscence; with periodontal probe; in mm)
Measured: within 14 days after augmentation
Secondary outcomes (7)
soft tissue healing quality
assess soft tissue healing quality using the Early Wound Healing Score (EHS); maximum of 10 points; cfr PMID31480586
Measured: day 7, 14, 30 and 120 after augmentation
Need for -re-intervantions
To monitor the need for re-interventions (yes/no)
Measured: within 30 days after augmentation
incidence of post-operative infection
Post-operative infection (yes/no; criteria: clinical diagnosis and/or need for systemic antibiotics)
Measured: within 30 days after augmentation
Gingival condition
Presence of recession or scarring
Measured: at 4 months after augmentation
Procedural parameters: closure tension
Feasibility/procedural parameters: closure tension (yes/no)
Measured: immediately after surgery
Procedural parameters: Periosteal release length
periosteal release length (mm)
Measured: Immediately after surgery
Procedural parameters: surgical time
total surgical time (s)
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insufficient Bone Volume Prior to Implant SurgeryStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, multicenter, single-arm case series conducted at four clinical centers in Belgium
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- 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)
- Responsible party
- Sponsor
- Investigators
- Ana B Castro, Professor, Principal investigator, UZLeuven, department of Oral Health Sciences, PeriodontologyAndy Temmerman, Professor, Principal investigator, ParoPlus AalstLorenz Seyssens, Dr, Principal investigator, ParoPlus AalstRutger Dhondt, Dr., Principal investigator, Radix DentalAlexander De Greef, Drs, Principal investigator, Parodontologie & Implantologie Merchtem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753525
- Sponsor's protocol ID
- S71663
- Acronym
- TCTechnique
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Tooth Collar Technique (TCT): a Prospective Case Series on a Novel Flap Design for Ridge Augmentation
- ClinicalTrials.gov ID
- NCT07753525
- Acronym / sponsor ID
- TCTechnique / S71663
- Keywords
- Implant surgery, wound dehiscence, Tooth Collar Technique, flap design, ridge augmentation, bone regeneration, wound closure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- 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 start
- Sep 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, multicenter, single-arm case series conducted at four clinical centers in Belgium
| Arm | Type | Receives |
|---|---|---|
| Tooth Collar Technique | Experimental | Procedure: Tooth Collar TechniqueParticipants of the study will receive surgery using the Tooth Collar Technique prior to ridge augmentation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth Collar TechniqueAlso: TCTechniqueDuring 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. | Procedure or surgery | Tooth Collar Technique |
Primary outcome
early wound dehiscence
Time frame: within 14 days after augmentation
Incidence of early wound dehiscence (yes/no) at the crest of the surgical site
Early Wound dehiscence
Time frame: within 14 days after augmentation
Documentation of location of wound dehiscence (if there is wound dehiscence) with clinical photo
primary wound healing
Time frame: 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.)
Early Wound dehiscence
Time frame: within 14 days after augmentation
Measurement of maximal defect dimension ( in case of wound dehiscence; with periodontal probe; in mm)
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana B Castro, Professor principal investigator
UZLeuven, department of Oral Health Sciences, Periodontology
Andy Temmerman, Professor principal investigator
ParoPlus Aalst
Lorenz Seyssens, Dr principal investigator
ParoPlus Aalst
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth Collar Technique in people with Insufficient Bone Volume Prior to Implant Surgery, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana B Castro Sarda, Professor (+32 16 332816, ana.castro@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early wound dehiscence (time frame: within 14 days after augmentation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.