Dental ImplantITI PROM RCTNCT07656597
Do Immediate Digital Workflows Increase Patient Value?
A study testing Immediate digital posterior implant workflow and Delayed digital posterior implant workflow in people with Dental Implant and Implant Therapy, run by Heinrich-Heine University, Duesseldorf at 2 sites in 2 countries.
Trial summary
This two-center randomized controlled trial will evaluate whether an immediate digital posterior implant workflow provides greater patient-defined value than a delayed digital workflow in adults requiring single posterior implant rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant, Implant Therapy, Immediate Dental Implant Placement
- What is being tested?
- Immediate digital posterior implant workflow and Delayed digital posterior implant workflow
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Nov 2026to 31 Oct 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
- Adults aged 18 years or older.
- Indication for single implant therapy in a posterior premolar or molar extraction site.
- Good oral hygiene with FMPS ≤20%.
- Controlled periodontitis according to protocol definition.
- At least one natural tooth adjacent to the implant site and presence of an antagonist tooth.
- Ability to comply with study procedures and provide written informed consent.
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- Adequate bone volume for immediate or delayed placement.
- Extraction site suitable for centrally positioned, prosthetically driven implant placement using straight prosthetic components.
- Ability to achieve 3-4 mm circumferential implant engagement in native bone along the planned implant axis while maintaining safety distance from vital structures.
- For molar sites, septal bone classified as Smith \& Tarnow Type A or Type B, including cases requiring closed sinus floor elevation.
- Post-extraction socket presenting as a contained or partially contained defect with at least three relatively intact socket walls and no individual socket wall vertical defect >5 mm.
- No facial soft-tissue dehiscence or mucogingival defect associated with buccal bone dehiscence.
Who cannot join
- • Known or suspected poor compliance, alcohol abuse, or substance abuse.
- Systemic or local contraindications to implant surgery.
- History of head/neck radiotherapy or recent malignancy within 5 years.
- Use of medications affecting bone metabolism.
- Bisphosphonate use within the past 5 years.
- Uncontrolled periodontal disease.
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- Heavy smoking (>10 cigarettes/day).
- Pregnancy or lactation.
- Teeth with periapical lesions >5 mm in greatest diameter, or sockets demonstrating a large cortical perforation >5 mm in greatest dimension on CBCT.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site
Department of Prosthodontics, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany
Düsseldorf, North Rhine-Westphalia, 40225
PD Dr. Frank Spitznagel, DMD, PhD, +49-211-81-04440, frank.spitznagel@med.uni-duesseldorf.de
PD Dr. Frank Spitznagel, DMD
Hong Kong1 site
The University of Hong Kong Department of Periodontology and Implant Dentistry, Faculty of Dentistry Prince Philip Dental Hospital
Hong Kong
Prof. Melissa Fok, DMD, +852 2859 0301, melfok@hku.hk
Prof. Melissa Fok, DMD
About this study
Official title: Do Immediate Digital Workflows Increase Patient Value? A Patient-Reported Outcome Measure-Based Randomized Controlled Trial Comparing Immediate Versus Delayed Digital Posterior Implant Workflows
This two-center randomized controlled trial will evaluate whether an immediate digital posterior implant workflow provides greater patient-defined value than a delayed digital workflow in adults requiring single posterior implant rehabilitation. Participants will be randomized 1:1 to immediate implant placement at the time of tooth extraction or to delayed implant placement after approximately 16 weeks of healing following extraction and ridge preservation as indicated. The primary endpoint is oral health-related quality of life assessed longitudinally using the OHIP-14 questionnaire and analyzed as the model-based mean score averaged across the active treatment phase from baseline through definitive crown delivery. Secondary outcomes include workflow-related patient experience, chairside time, number of visits, postoperative pain, buccal contour changes based on intraoral scan-derived volumetric analysis, radiographic marginal bone level changes, implant survival, clinical peri-implant parameters, technical complications, esthetic outcomes, accuracy of guided implant placement, and clinician-reported workflow outcomes.
Read the detailed description
Digital implant workflows enable guided surgery, intraoral scanning, and standardized restorative components, and may reduce treatment burden while supporting efficient, patient-centered care. In posterior single-tooth implant rehabilitation, immediate and delayed placement protocols have been extensively evaluated from a biological perspective, but evidence on patient-reported oral health-related quality of life and workflow efficiency remains limited.
The study compares two standardized digital posterior implant rehabilitation pathways that differ in implant placement timing: immediate placement (Type 1C) versus delayed placement (Type 4B). Participants requiring extraction and single implant therapy in posterior premolar or molar sites will be enrolled at two geographically distinct centers. The immediate workflow combines atraumatic extraction and guided implant placement in one surgical session. The delayed workflow includes extraction and ridge preservation as indicated, followed by implant placement after approximately 16 weeks of healing. Both groups will receive guided implant placement with Straumann BLC implants and a screw-retained monolithic zirconia crown according to the protocol.
The primary objective is to compare the overall treatment-related impact on oral health-related quality of life during the active treatment phase using OHIP-14. Key secondary objectives are to compare workflow-related patient experience, objective workflow efficiency, and peri-implant soft tissue contour changes, while monitoring clinical, radiographic, esthetic, implant-related, and prosthetic safety outcomes.
- Conditions
- Dental Implant, Implant Therapy, Immediate Dental Implant Placement, Delayed Implant, Guided Surgery Accuracy, Patient-Reported Outcomes (PRO)
- Being tested
- Immediate digital posterior implant workflow, Delayed digital posterior implant workflow
- Keywords
- Dental Implant, immediate implant placement, delayed implant placement, digital workflow, guided surgery, patient-reported outcomes, OHIP-14, posterior implant rehabilitation, chairside time, volumetric analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate digital posterior implant workflowProcedure or surgery
Also called Immediate implant placement, Type 1C implant placement, Immediate digital workflow, Immediate posterior implant rehabilitation
Participants allocated to the immediate digital workflow will undergo atraumatic extraction of a non-restorable posterior tooth followed by immediate implant placement during the same surgical session. Implant placement will be performed using a prosthetically driven digital workflow with static guided surgery. Socket management and sealing of the extraction socket will be performed according to the standardized study protocol and local standard of care. Definitive prosthetic restoration will be delivered after the planned healing period.
Delayed digital posterior implant workflowProcedure or surgery
Also called Delayed implant placement, Type 4B implant placement, Delayed digital workflow, Delayed posterior implant rehabilitation
Participants allocated to the delayed digital workflow will undergo atraumatic extraction of a non-restorable posterior tooth followed by alveolar ridge preservation as indicated according to the standardized study protocol and local standard of care. Implant placement will be performed after approximately 16 weeks of healing using a prosthetically driven digital workflow with static guided surgery. Definitive prosthetic restoration will be delivered after the planned healing period.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Digital Workflow / Immediate Implant Placement (Type 1C) | Experimental | Atraumatic tooth extraction and guided implant placement during the same surgical session. Socket management follows the standardized protocol according to defect morphology. Implants are sealed without functional loading and restored with a definitive screw-retained monolithic zirconia crown after healing. Receives: Procedure: Immediate digital posterior implant workflow |
| Delayed Digital Workflow / Delayed Implant Placement (Type 4B) | Active comparator | Tooth extraction with alveolar ridge preservation as required. Implant placement is performed after approximately 16 weeks of healing using the same surgical and prosthetic protocol. Definitive restoration is delivered after healing following implant placement. Receives: Procedure: Delayed digital posterior implant workflow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health-related quality of life (OHIP) assessed with OHIP-14 Questionnaire: model-based mean OHIP-14 score averaged across the active treatment phase (0-4 months).
The primary estimand is the between-group difference in model-based least-squares mean OHIP-14 scores (0-4) averaged across the active treatment phase. Lower OHIP-14 scores indicate lower treatment-related impact / better oral health-related quality of life.
Measured: Baseline / enrollment (0 months), 7 days after surgical intervention(s), and definitive crown delivery (approximately 4 months); approximately baseline (0 months) through 4-6 months depending on allocation.
Secondary outcomes (10)
Workflow-Related Patient Experience
Overall treatment experience assessed using a Visual Analogue Scale (VAS 0-100) at crown delivery and at 12-months follow-up. Higher scores indicate greater perceived treatment experience and perceived value of the treatment pathway.
Measured: Crown delivery (Baseline loading 0 months) and 12-months follow-up post loading
Workflow Efficiency
Chairside time (in minutes) per visit and cumulative chairside time (in minutes) from enrollment through crown delivery (Visit 1-4); number of visits and unplanned interventions (measured in time per minutes).
Measured: Visit 1-4 (0 months - up to 4-6 months).
Buccal Contour Changes
Volumetric region-of-interest shrinkage / contour change derived from serial intraoral scans at protocol-defined visits through from baseline till 12 months after loading
Measured: Visit 1 (Baseline), Visit 2 (+ 2-4 weeks), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Radiographic Outcomes
Marginal bone level changes at implant placement, loading, +6 months, and +12 months post loading (measured in mm); proportion of implants with >1 mm or >2 mm marginal bone loss.
Measured: Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Clinical Soft Tissue Outcomes 1
Mid-buccal mucosal level (in mm), keratinized mucosa width (in mm), probing pocket depth (in mm), recession/dehiscence (in mm)
Measured: Visit 1 (Baseline), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Clinical Soft Tissue Outcome 2
Bleeding on probing (in % number of bleeding surfaces/total number of surfaces), Plaque index (in % number of bleeding surfaces/total number of surfaces)
Measured: Visit 1 (Baseline), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Implant/prosthetic outcomes
Implant survival at 6 and 12 months post-loading; technical complications; prosthetic success according to modified United States Public Health (USPHS) criteria.
Measured: Visit 5 (+4-5 months from Baseline), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Pink and White Esthetics
Pink Esthetic Score/ White Esthetic Score (PES/WES);
The PES and WES scores allow an objective evaluation of the aesthetics of implant supported single crowns and adjacent soft tissues based on five parameters:
PES:
- Mesial papilla
- Distal papilla
- Curvature of facial mucosa
- Level of facial mucosa
- Root convexity/ soft tissue colour and texture
WES:
- Tooth form
- Outline and volume of the clinical crown
- Colour, which includes the assessment of the dimension's hue and value
- Surface texture
- Translucency and characterization
Each variable will be assessed using a 0-1-2 scoring system; 0 being the lowest, and 2 being the highest value. Hence, the highest possible PES and WES score is 10 each, whereas the highest possible combined PES/WES score is 20
Measured: Visit 1 (Baseline), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Clinician-reported outcomes
Procedural difficulty and workflow perception assessed using a numeric rating scale (NRS, 0-10) at extraction and implant placement (0 = extremely easy, 10 = extremely difficult)
- Clinician satisfaction with treatment workflow and outcome assessed at crown delivery and 12 months (0 = extremely dissatisfied, 10 = extremely satisfied)
- Clinician stress level during surgery (extraction and implant placement) measuring physiological stress (assessed by heart rate) and psychological stress and workload (assessed by two questionnaires: short-form State-Trait Anxiety Inventory (STAI-6) and the Surgery Task Load Index (SURG-TLX)
Measured: Visit 2 (+ 2-4 weeks), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Implant Accuracy
Implant Placement Accuracy. Planned versus actual implant position including angulation (in degrees), platform deviation (in mm), and apex deviation (in mm).
Measured: Visit 3 (+0-4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start3 Nov 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, ITI International Team for Implantology, Switzerland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656597
- Sponsor's protocol ID
- 2115-2026
- Other IDs
- 2115-2026
- Acronym
- ITI PROM RCT
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to data protection and ethical restrictions. Aggregated study results will be disseminated through peer-reviewed publication.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Immediate Digital Workflows Increase Patient Value? A Patient-Reported Outcome Measure-Based Randomized Controlled Trial Comparing Immediate Versus Delayed Digital Posterior Implant Workflows
- ClinicalTrials.gov ID
- NCT07656597
- Acronym / sponsor ID
- ITI PROM RCT / 2115-2026
- Conditions
- Dental Implant, Implant Therapy, Immediate Dental Implant Placement, Delayed Implant, Guided Surgery Accuracy, Patient-Reported Outcomes (PRO)
- Keywords
- Dental Implant, immediate implant placement, delayed implant placement, digital workflow, guided surgery, patient-reported outcomes, OHIP-14, posterior implant rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- The University of Hong Kong, ITI International Team for Implantology, Switzerland
- Study start
- 3 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 18 Jun 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.
This two-center randomized controlled trial will evaluate whether an immediate digital posterior implant workflow provides greater patient-defined value than a delayed digital workflow in adults requiring single posterior implant rehabilitation. Participants will be randomized 1:1 to immediate implant placement at the time of tooth extraction or to delayed implant placement after approximately 16 weeks of healing following extraction and ridge preservation as indicated. The primary endpoint is oral health-related quality of life assessed longitudinally using the OHIP-14 questionnaire and analyzed as the model-based mean score averaged across the active treatment phase from baseline through definitive crown delivery. Secondary outcomes include workflow-related patient experience, chairside time, number of visits, postoperative pain, buccal contour changes based on intraoral scan-derived volumetric analysis, radiographic marginal bone level changes, implant survival, clinical peri-implant parameters, technical complications, esthetic outcomes, accuracy of guided implant placement, and clinician-reported workflow outcomes.
Detailed description
Digital implant workflows enable guided surgery, intraoral scanning, and standardized restorative components, and may reduce treatment burden while supporting efficient, patient-centered care. In posterior single-tooth implant rehabilitation, immediate and delayed placement protocols have been extensively evaluated from a biological perspective, but evidence on patient-reported oral health-related quality of life and workflow efficiency remains limited.
The study compares two standardized digital posterior implant rehabilitation pathways that differ in implant placement timing: immediate placement (Type 1C) versus delayed placement (Type 4B). Participants requiring extraction and single implant therapy in posterior premolar or molar sites will be enrolled at two geographically distinct centers. The immediate workflow combines atraumatic extraction and guided implant placement in one surgical session. The delayed workflow includes extraction and ridge preservation as indicated, followed by implant placement after approximately 16 weeks of healing. Both groups will receive guided implant placement with Straumann BLC implants and a screw-retained monolithic zirconia crown according to the protocol.
The primary objective is to compare the overall treatment-related impact on oral health-related quality of life during the active treatment phase using OHIP-14. Key secondary objectives are to compare workflow-related patient experience, objective workflow efficiency, and peri-implant soft tissue contour changes, while monitoring clinical, radiographic, esthetic, implant-related, and prosthetic safety outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Digital Workflow / Immediate Implant Placement (Type 1C) | Experimental | Procedure: Immediate digital posterior implant workflowAtraumatic tooth extraction and guided implant placement during the same surgical session. Socket management follows the standardized protocol according to defect morphology. Implants are sealed without functional loading and restored with a definitive screw-retained monolithic zirconia crown after healing. |
| Delayed Digital Workflow / Delayed Implant Placement (Type 4B) | Active comparator | Procedure: Delayed digital posterior implant workflowTooth extraction with alveolar ridge preservation as required. Implant placement is performed after approximately 16 weeks of healing using the same surgical and prosthetic protocol. Definitive restoration is delivered after healing following implant placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults aged 18 years or older.
- Indication for single implant therapy in a posterior premolar or molar extraction site.
- Good oral hygiene with FMPS ≤20%.
- Controlled periodontitis according to protocol definition.
- At least one natural tooth adjacent to the implant site and presence of an antagonist tooth.
Key exclusion criteria (9 listed)
- • Known or suspected poor compliance, alcohol abuse, or substance abuse.
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 |
|---|---|---|
| Immediate digital posterior implant workflowAlso: Immediate implant placement, Type 1C implant placement, Immediate digital workflow, Immediate posterior implant rehabilitationParticipants allocated to the immediate digital workflow will undergo atraumatic extraction of a non-restorable posterior tooth followed by immediate implant placement during the same surgical session. Implant placement will be performed using a prosthetically driven digital workflow with static guided surgery. Socket management and sealing of the extraction socket will be performed according to the standardized study protocol and local standard of care. Definitive prosthetic restoration will be delivered after the planned healing period. | Procedure or surgery | Immediate Digital Workflow / Immediate Implant Placement (Type 1C) |
| Delayed digital posterior implant workflowAlso: Delayed implant placement, Type 4B implant placement, Delayed digital workflow, Delayed posterior implant rehabilitationParticipants allocated to the delayed digital workflow will undergo atraumatic extraction of a non-restorable posterior tooth followed by alveolar ridge preservation as indicated according to the standardized study protocol and local standard of care. Implant placement will be performed after approximately 16 weeks of healing using a prosthetically driven digital workflow with static guided surgery. Definitive prosthetic restoration will be delivered after the planned healing period. | Procedure or surgery | Delayed Digital Workflow / Delayed Implant Placement (Type 4B) |
Primary outcome
Oral health-related quality of life (OHIP) assessed with OHIP-14 Questionnaire: model-based mean OHIP-14 score averaged across the active treatment phase (0-4 months).
Time frame: Baseline / enrollment (0 months), 7 days after surgical intervention(s), and definitive crown delivery (approximately 4 months); approximately baseline (0 months) through 4-6 months depending on allocation.
The primary estimand is the between-group difference in model-based least-squares mean OHIP-14 scores (0-4) averaged across the active treatment phase. Lower OHIP-14 scores indicate lower treatment-related impact / better oral health-related quality of life.
10 secondary outcomes
Workflow-Related Patient Experience
Time frame: Crown delivery (Baseline loading 0 months) and 12-months follow-up post loading
Workflow Efficiency
Time frame: Visit 1-4 (0 months - up to 4-6 months).
Buccal Contour Changes
Time frame: Visit 1 (Baseline), Visit 2 (+ 2-4 weeks), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Radiographic Outcomes
Time frame: Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Clinical Soft Tissue Outcomes 1
Time frame: Visit 1 (Baseline), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Clinical Soft Tissue Outcome 2
Time frame: Visit 1 (Baseline), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Implant/prosthetic outcomes
Time frame: Visit 5 (+4-5 months from Baseline), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Pink and White Esthetics
Time frame: Visit 1 (Baseline), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Clinician-reported outcomes
Time frame: Visit 2 (+ 2-4 weeks), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Implant Accuracy
Time frame: Visit 3 (+0-4 months)
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 13 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to data protection and ethical restrictions. Aggregated study results will be disseminated through peer-reviewed publication.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate digital posterior implant workflow and Delayed digital posterior implant workflow in people with Dental Implant and Implant Therapy, run by Heinrich-Heine University, Duesseldorf at 2 sites in 2 countries.
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 12 inclusion and 9 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 13 Oct 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 Germany, Hong Kong. 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 PD Dr. Frank Spitznagel, DMD (+49-211-81-04440, frank.spitznagel@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral health-related quality of life (OHIP) assessed with OHIP-14 Questionnaire: model-based mean OHIP-14 score averaged across the active treatment phase (0-4 months). (time frame: Baseline / enrollment (0 months), 7 days after surgical intervention(s), and definitive crown delivery (approximately 4 months); approximately baseline (0 months) through 4-6 months depending on allocation.). 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 13 Oct 2026.