Tooth Loss and RehabillitationAzentoNCT07731854
Custom Provisionalisation
A study testing Fully guided implant placement, Free handed implant placement and individualised abutment + digital prepared provisional crown in people with Tooth Loss and Rehabillitation, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial summary
Fully digital immediate implant treatment by means of fully guided implant placement and custom designed provisionalisation with a individual designed abutment and temporary PMMA crown leads to better esthetic outcomes than free handed with regular provisionalisation on a temporary cylinder. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Tooth Loss and Rehabillitation
- What is being tested?
- Fully guided implant placement, Free handed implant placement and individualised abutment + digital prepared provisional crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesBelgium
- Study dates
- 29 May 2022to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Males or females ASA I or II, between 25 to 80 years of age
- One tooth in the high esthetic region planned for extraction.
- Patient in good general health as documented by self-assessment.
- Patients must be committed to the study and must be willing to sign the informed consent.
Who cannot join
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Any systemic medical condition that could interfere with the surgical procedure or planned treatment.
- Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
- Current pregnancy or breast feeding/ lactating at the time of recruitment.
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- Radiotherapy or Chemotherapy in head and neck area.
- Intravenous and oral bisphosphonate therapy.
- Smokers
- Unwillingness to return for the follow-up examination.
- Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations.
- Presence of osseous pathologies, that may interfere with normal wound healing.
- Presence of oral lesions (such as ulceration, malignancy).
- Local inflammation, including untreated periodontitis.
- Patients with inadequate oral hygiene or unmotivated for adequate home care
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
UZ Gent
Ghent, Oost-Vlaanderen, 9000
UZLeuven, Campus St. Raphaël, Department Oral Health Sciences, Periodontology
Leuven, Vlaams Brabant, 3000
About this study
Official title: The Esthetic Outcome of Custom-Designed Profisionalisations of Immediate Implants in the Esthetic Zone: a Randomized, Controlled, Clinical Trial.
Fully digital immediate implant treatment by means of fully guided implant placement and custom designed provisionalisation with a individual designed abutment and temporary PMMA crown leads to better esthetic outcomes than free handed with regular provisionalisation on a temporary cylinder.
Read the detailed description
Since many years dental implants serve as long-term predictable anchors for fixed and removable prostheses in fully and partially edentulous patients. A dental implant is a screw that is inserted into the jawbone to provide fixed support for a single crown, fixed partial/full denture or an overdenture. After local anaesthesia, the implant is inserted into a cavity that has been drilled into the jaw. New bone is allowed to grow around the implant for up to 3 till 6 months before a prosthetic device is attached.
Via a connecting element - 'abutment' - the crown, bridge or denture is attached to the dental implant. The abutment can be placed immediately after implant placement - 'one-stage surgery' - or during a second surgery - 'two-stage surgery'. In certain cases this abutment can already contain a provisional crown (a tooth).
Immediate implant placement and provisionalisation offers great benefits for the patient: one intervention, immediate tooth replacement, minimally invasiveness to name just a couple.
However, in recent years, there has been a debate in the scientific community on the long term esthetic outcome. This is important as this concept is predominantly used in high esthetic regions. Scientific evidence is frequently contradictory and confusing.
Digitalisation has found its way into implant dentistry. The combination of CBCT images and IO-scan images give the clinician and/or company the opportunity to plan the surgery in advance (even when the natural tooth is still in place). This might lead to 'guided' implant surgery (where the position of the implant is defined through a surgical guide) but also to custom-designed provisionalisation.
- Conditions
- Tooth Loss and Rehabillitation
- Being tested
- Fully guided implant placement, Free handed implant placement, individualised abutment + digital prepared provisional crown, Provisional Cylinder + conventional provisional crown
- Keywords
- guided implant surgery, immediate implant treatment, esthetic outcome, provisionalisation
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully guided implant placementProcedure or surgery
immediate implant placement with digital workflow
Free handed implant placementProcedure or surgery
immediate implant placement conventional workflow
individualised abutment + digital prepared provisional crownProcedure or surgery
immediate loading with digital workflow
Provisional Cylinder + conventional provisional crownProcedure or surgery
immediate loading with conventional workflow
| Study group | Role | What they receive |
|---|---|---|
| Digital workflow (Azento) | Active comparator | Fully guided implant placement + individualized abutment + digital prepared proviosional crown Receives: Procedure: Fully guided implant placement; Procedure: individualised abutment + digital prepared provisional crown |
| Conventional workflow | Placebo comparator | Free handed Implant placement + provisional cylinder + conventional provisional crown Receives: Procedure: Free handed implant placement; Procedure: Provisional Cylinder + conventional provisional crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
mid-facial recession (mm)
measurement CEJ to free gingival margin with periodontal probe
Measured: 6 months and 1 year after surgery
PES (pink esthetic score)
assesses the soft tissue (gums); score 0-20
Measured: 6 months and 1 year after surgery
WES (white esthetic score
Assesses the tooth itself in relation to the neigboring natural elements; score 0-20
Measured: 6 months and 1 year after surgery
Secondary outcomes (3)
buccal bone thickness
measured on CBCT; in mm
Measured: at implant surgery, 6 months and 1 year after surgery
Surgical time
measured from the moment of extraction to the placement of the provisional (seconds)
Measured: during surgery
Implant success
Is the amount of marginal bone loss equal or less to the preestablished numbers to be called implant success? (yes/no)
Measured: 6 months and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start29 May 2022
- Primary completion31 Dec 2025
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Loss and RehabillitationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Andy Temmerman, Professor, Principal investigator, UZLeuven, department of Oral Health Sciences, Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731854
- Sponsor's protocol ID
- S65361
- Acronym
- Azento
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Esthetic Outcome of Custom-Designed Profisionalisations of Immediate Implants in the Esthetic Zone: a Randomized, Controlled, Clinical Trial.
- ClinicalTrials.gov ID
- NCT07731854
- Acronym / sponsor ID
- Azento / S65361
- Conditions
- Tooth Loss and Rehabillitation
- Keywords
- guided implant surgery, immediate implant treatment, esthetic outcome, provisionalisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- 29 May 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 28 Jul 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.
Fully digital immediate implant treatment by means of fully guided implant placement and custom designed provisionalisation with a individual designed abutment and temporary PMMA crown leads to better esthetic outcomes than free handed with regular provisionalisation on a temporary cylinder.
Detailed description
Since many years dental implants serve as long-term predictable anchors for fixed and removable prostheses in fully and partially edentulous patients. A dental implant is a screw that is inserted into the jawbone to provide fixed support for a single crown, fixed partial/full denture or an overdenture. After local anaesthesia, the implant is inserted into a cavity that has been drilled into the jaw. New bone is allowed to grow around the implant for up to 3 till 6 months before a prosthetic device is attached.
Via a connecting element - 'abutment' - the crown, bridge or denture is attached to the dental implant. The abutment can be placed immediately after implant placement - 'one-stage surgery' - or during a second surgery - 'two-stage surgery'. In certain cases this abutment can already contain a provisional crown (a tooth).
Immediate implant placement and provisionalisation offers great benefits for the patient: one intervention, immediate tooth replacement, minimally invasiveness to name just a couple.
However, in recent years, there has been a debate in the scientific community on the long term esthetic outcome. This is important as this concept is predominantly used in high esthetic regions. Scientific evidence is frequently contradictory and confusing.
Digitalisation has found its way into implant dentistry. The combination of CBCT images and IO-scan images give the clinician and/or company the opportunity to plan the surgery in advance (even when the natural tooth is still in place). This might lead to 'guided' implant surgery (where the position of the implant is defined through a surgical guide) but also to custom-designed provisionalisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital workflow (Azento) | Active comparator | Procedure: Fully guided implant placement, Procedure: individualised abutment + digital prepared provisional crownFully guided implant placement + individualized abutment + digital prepared proviosional crown |
| Conventional workflow | Placebo comparator | Procedure: Free handed implant placement, Procedure: Provisional Cylinder + conventional provisional crownFree handed Implant placement + provisional cylinder + conventional provisional crown |
Who may qualify
- Ages
- 25 to 80 years
- 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 legally authorized representative has been obtained prior to any screening procedures
- Males or females ASA I or II, between 25 to 80 years of age
- One tooth in the high esthetic region planned for extraction.
- Patient in good general health as documented by self-assessment.
- Patients must be committed to the study and must be willing to sign the informed consent.
Key exclusion criteria (15 listed)
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Any systemic medical condition that could interfere with the surgical procedure or planned treatment.
- Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
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 |
|---|---|---|
| Fully guided implant placementimmediate implant placement with digital workflow | Procedure or surgery | Digital workflow (Azento) |
| Free handed implant placementimmediate implant placement conventional workflow | Procedure or surgery | Conventional workflow |
| individualised abutment + digital prepared provisional crownimmediate loading with digital workflow | Procedure or surgery | Digital workflow (Azento) |
| Provisional Cylinder + conventional provisional crownimmediate loading with conventional workflow | Procedure or surgery | Conventional workflow |
Primary outcome
mid-facial recession (mm)
Time frame: 6 months and 1 year after surgery
measurement CEJ to free gingival margin with periodontal probe
PES (pink esthetic score)
Time frame: 6 months and 1 year after surgery
assesses the soft tissue (gums); score 0-20
WES (white esthetic score
Time frame: 6 months and 1 year after surgery
Assesses the tooth itself in relation to the neigboring natural elements; score 0-20
3 secondary outcomes
buccal bone thickness
Time frame: at implant surgery, 6 months and 1 year after surgery
Surgical time
Time frame: during surgery
Implant success
Time frame: 6 months and 1 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 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. This study is not recruiting at the moment.
Andy Temmerman, Professor principal investigator
UZLeuven, department of Oral Health Sciences, Periodontology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully guided implant placement, Free handed implant placement and individualised abutment + digital prepared provisional crown in people with Tooth Loss and Rehabillitation, run by Universitaire Ziekenhuizen KU Leuven at 2 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 15 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: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mid-facial recession (mm) (time frame: 6 months and 1 year after surgery). The study lists 3 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 28 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.