Tooth Loss in the Esthetic Zone Requiring Immediate Implant PlacementPRODIGINCT07700771
Influence of Provisional Restoration Type on Outcomes of Immediate Implant Placement and Loading
A study testing 3D-Printed Resin Provisional Crown and CAD/CAM-Milled PMMA Provisional Crown in people with Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement and Immediate Dental Implant Placement, run by Mansoura University at 1 site in Egypt.
Trial summary
A randomized clinical trial comparing 3D-printed resin and CAD/CAM-milled PMMA provisional restorations used for immediate loading of fully digitally guided immediate implants. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement, Immediate Dental Implant Placement, Immediate Loading
- What is being tested?
- 3D-Printed Resin Provisional Crown and CAD/CAM-Milled PMMA Provisional Crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 30 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients presenting with non-restorable teeth in the maxillary esthetic zone indicated for extraction and immediate implant placement.
- Age ranging from 18 to 50 years.
- Adequate interarch relationship and interocclusal space to accommodate the planned prosthetic restoration.
- Intact extraction socket walls with a jumping gap not exceeding 4 mm, as measured on preoperative CBCT images. The jumping gap will be defined as the horizontal distance between the implant surface and the inner aspect of the buccal socket wall and will be grafted in all cases.
- Good oral hygiene and periodontal health.
- Willingness to attend all follow-up visits and comply with study requirements.
Who cannot join
- Presence of acute infection, pathological lesions, or severe periodontal disease at the planned implant site.
- Smokers.
- Alcohol or drug abuse.
- Patients with systemic conditions contraindicating implant surgery (e.g., uncontrolled diabetes mellitus, bleeding disorders, immunosuppression, recent radiotherapy to the head and neck region).
- Pregnancy or lactation.
- Patients with parafunctional habits such as bruxism or clenching.
- Inability to maintain adequate oral hygiene or attend follow-up visits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry Mansoura University
Al Mansurah, Dakahlia Governorate
About this study
Official title: Influence of Provisional Restoration Type on Clinical Outcomes of Fully Digital Single-Visit Immediate Implant Placement and Loading: A Randomized Clinical Trial
A randomized clinical trial comparing 3D-printed resin and CAD/CAM-milled PMMA provisional restorations used for immediate loading of fully digitally guided immediate implants.
Read the detailed description
Sixty patients were randomly allocated to receive either a 3D-printed resin or a CAD/CAM-milled PMMA provisional crown used for immediate loading after fully digitally guided immediate implant placement in the maxillary esthetic zone. Clinical and peri-implant soft tissue outcomes will be evaluated.
- Conditions
- Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement, Immediate Dental Implant Placement, Immediate Loading, Provisional Restoration, Digital Implant Dentistry
- Being tested
- 3D-Printed Resin Provisional Crown, CAD/CAM-Milled PMMA Provisional Crown
- Keywords
- Immediate implant placement, Immediate loading, Digital workflow, Guided implant surgery, Provisional restoration, 3D-printed resin, CAD/CAM-milled PMMA, Maxillary esthetic zone, Customized healing abutment, Peri-implant soft tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Printed Resin Provisional CrownProcedure or surgery
A digitally designed and 3D-printed resin immediate provisional crown was delivered immediately after fully guided implant placement in the maxillary esthetic zone and served as a customized healing abutment.
CAD/CAM-Milled PMMA Provisional CrownProcedure or surgery
A digitally designed CAD/CAM-milled PMMA immediate provisional crown was delivered immediately after fully guided implant placement in the maxillary esthetic zone and served as a customized healing abutment.
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1 (3D-Printed resin Group) | Experimental | Thirty patients received a digitally designed 3D-printed resin immediate provisional crown for immediate loading, serving as a customized healing abutment following fully guided immediate implant placement in the maxillary esthetic zone. Receives: Procedure: 3D-Printed Resin Provisional Crown |
| Study Group 2 (CAD/CAM-Milled PMMA Group) | Experimental | Thirty patients received a digitally designed CAD/CAM-milled PMMA immediate provisional crown for immediate loading, serving as a customized healing abutment following fully guided immediate implant placement in the maxillary esthetic zone. Receives: Procedure: CAD/CAM-Milled PMMA Provisional Crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant soft tissue changes
Soft tissue contour and peri-implant tissue condition will be assessed using digital intraoral scanning (STL files) using superimposition.
Measured: Baseline (immediately after provisionalization), 1 month, 3 months, and 6 months postoperatively.
Secondary outcomes (2)
Pink Esthetic Score (PES)
Peri-implant soft tissue esthetics were assessed using the Pink Esthetic Score (0-14). Higher scores indicated better esthetic outcomes.
Measured: After 3 and 6 months postoperatively.
Implant stability
Implant stability will be evaluated using Osstell device based on resonance frequency analysis (ISQ values).
Measured: Immediate post-operative and at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Dec 2025
- Primary completion30 Jun 2026
- Study completion30 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 in the Esthetic Zone Requiring Immediate Implant PlacementStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700771
- Sponsor's protocol ID
- R.26.06.127
- Acronym
- PRODIGI
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Provisional Restoration Type on Clinical Outcomes of Fully Digital Single-Visit Immediate Implant Placement and Loading: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07700771
- Acronym / sponsor ID
- PRODIGI / R.26.06.127
- Conditions
- Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement, Immediate Dental Implant Placement, Immediate Loading, Provisional Restoration, Digital Implant Dentistry
- Keywords
- Immediate implant placement, Immediate loading, Digital workflow, Guided implant surgery, Provisional restoration, 3D-printed resin, CAD/CAM-milled PMMA, Maxillary esthetic zone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 14 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.
A randomized clinical trial comparing 3D-printed resin and CAD/CAM-milled PMMA provisional restorations used for immediate loading of fully digitally guided immediate implants.
Detailed description
Sixty patients were randomly allocated to receive either a 3D-printed resin or a CAD/CAM-milled PMMA provisional crown used for immediate loading after fully digitally guided immediate implant placement in the maxillary esthetic zone. Clinical and peri-implant soft tissue outcomes will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 (3D-Printed resin Group) | Experimental | Procedure: 3D-Printed Resin Provisional CrownThirty patients received a digitally designed 3D-printed resin immediate provisional crown for immediate loading, serving as a customized healing abutment following fully guided immediate implant placement in the maxillary esthetic zone. |
| Study Group 2 (CAD/CAM-Milled PMMA Group) | Experimental | Procedure: CAD/CAM-Milled PMMA Provisional CrownThirty patients received a digitally designed CAD/CAM-milled PMMA immediate provisional crown for immediate loading, serving as a customized healing abutment following fully guided immediate implant placement in the maxillary esthetic zone. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients presenting with non-restorable teeth in the maxillary esthetic zone indicated for extraction and immediate implant placement.
- Age ranging from 18 to 50 years.
- Adequate interarch relationship and interocclusal space to accommodate the planned prosthetic restoration.
- Intact extraction socket walls with a jumping gap not exceeding 4 mm, as measured on preoperative CBCT images. The jumping gap will be defined as the horizontal distance between the implant surface and the inner aspect of the buccal socket wall and will be grafted in all cases.
- Good oral hygiene and periodontal health.
Key exclusion criteria (7 listed)
- Presence of acute infection, pathological lesions, or severe periodontal disease at the planned implant site.
- Smokers.
- Alcohol or drug abuse.
- Patients with systemic conditions contraindicating implant surgery (e.g., uncontrolled diabetes mellitus, bleeding disorders, immunosuppression, recent radiotherapy to the head and neck region).
- Pregnancy or lactation.
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 |
|---|---|---|
| 3D-Printed Resin Provisional CrownA digitally designed and 3D-printed resin immediate provisional crown was delivered immediately after fully guided implant placement in the maxillary esthetic zone and served as a customized healing abutment. | Procedure or surgery | Study Group 1 (3D-Printed resin Group) |
| CAD/CAM-Milled PMMA Provisional CrownA digitally designed CAD/CAM-milled PMMA immediate provisional crown was delivered immediately after fully guided implant placement in the maxillary esthetic zone and served as a customized healing abutment. | Procedure or surgery | Study Group 2 (CAD/CAM-Milled PMMA Group) |
Primary outcome
Peri-implant soft tissue changes
Time frame: Baseline (immediately after provisionalization), 1 month, 3 months, and 6 months postoperatively.
Soft tissue contour and peri-implant tissue condition will be assessed using digital intraoral scanning (STL files) using superimposition.
2 secondary outcomes
Pink Esthetic Score (PES)
Time frame: After 3 and 6 months postoperatively.
Implant stability
Time frame: Immediate post-operative and at 3 months.
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 22 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement
Not yet recruiting
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
Partial Edentulism, Dental Implant
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-Printed Resin Provisional Crown and CAD/CAM-Milled PMMA Provisional Crown in people with Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement and Immediate Dental Implant Placement, run by Mansoura University at 1 site in Egypt.
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 6 inclusion and 7 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
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?
Peri-implant soft tissue changes (time frame: Baseline (immediately after provisionalization), 1 month, 3 months, and 6 months postoperatively.). 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 22 Sep 2026.