Partial EdentulismNCT07882095
Immediate vs Conventional Loading With Different Crown Materials on Immediately Placed Single Implants
A study testing Conventional loading, Monolithic zirconia crown and Permanent 3D-printed PMMA crown in people with Partial Edentulism and Dental Implant, run by Ain Shams University at 2 sites in Egypt.
Trial summary
This randomized controlled trial compares immediate and conventional loading of single implants placed immediately into fresh extraction sockets in the upper front and premolar region. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Partial Edentulism, Dental Implant, Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement
- What is being tested?
- Conventional loading, Monolithic zirconia crown and Permanent 3D-printed PMMA crown
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Nov 2026to 25 Mar 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 21 years or older
- Single tooth requiring extraction and replacement in the maxillary anterior or premolar region (sites 15 to 25), with a gap bounded by natural teeth
- Adjacent tooth present
- Opposing dentition of natural teeth or a fixed tooth- or implant-supported prosthesis
- Extraction socket Elian Type I or Type II
- Adequate oral hygiene: bleeding on probing <20% and plaque index <20%
- Implant insertion torque ≥35 Ncm at placement
Who cannot join
- Pregnant or lactating women
- Systemic or local contraindication to implant treatment
- Smokers
- Current drugs affecting bone metabolism
- Bisphosphonate use in the last 4 years
- Malignancy, radiotherapy or chemotherapy for malignancy in the past 5 years
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Assiut University
Asyut, Asyut Governorate, 71111
Abdelrahman Khalaf El Dabe Ahmed, Lecturer, 01097742557 ext. +2, Abdodent84@yahoo.com
Kirollos Hany Botros Bernaba, Lecturer Assistant
Ain Shams University
Cairo, Cairo Governorate, 71111
Doaa Adel Khattab, Assistant Professor, 01006814258 ext. +2, dr.doaa.adel-khattab@dent.asu.edu.eg
About this study
Official title: Impact of Loading Protocol (Immediate vs. Conventional) and Prosthetic Material (Temporary vs. Definitive) on the Clinical Outcomes of Immediately Placed Implants: A Randomized Controlled Comparative Study
This randomized controlled trial compares immediate and conventional loading of single implants placed immediately into fresh extraction sockets in the upper front and premolar region. Eighty adults will be randomly assigned to four groups: immediate loading (within 48 hours) with a definitive zirconia crown, a permanent printed PMMA crown, or a temporary printed PMMA crown, or conventional loading with a definitive zirconia crown after 3 months. All implants are placed with a fully guided digital workflow.
Read the detailed description
Design: parallel-group, four-arm randomized controlled trial at the Faculties of Dentistry of Ain Shams University and Assiut University. Eighty patients requiring single-tooth replacement Planning and surgery: CBCT (Veraview X800) and intraoral scans (Shining 3D Elite) are merged in exoplan for prosthetically driven planning; fully guided surgical guides are DLP-printed. Teeth are extracted flaplessly and PowerBone implants (Ti-6Al-4V, SLA-type surface, internal connection) are placed through the guide. Only implants reaching an insertion torque of at least 35 Ncm proceed; otherwise a wider implant is used or the patient is excluded.
Randomization: computer-generated list held by an investigator not involved in treatment; sequentially numbered, opaque, sealed envelopes are opened only after implant placement.
Prosthetic phase: in Groups I-III a screw-retained crown on a titanium base is delivered within 48 hours in infra-occlusion (no centric or excursive contacts). At 3 months these crowns are replaced with definitive monolithic zirconia crowns in full occlusion. Group IV receives a cover screw and a definitive monolithic zirconia crown in full occlusion at 3 months.
Primary analysis: non-inferiority of Group I vs Group IV for 12-month marginal bone level change, margin 0.5 mm, using the upper limit of the two-sided 95% CI. Per-protocol analysis is primary; intention-to-treat is also reported. Sample size: SD 0.5 mm, one-sided alpha 0.025, power 80% gives 16 per group, increased to 20 per group for dropout.
Secondary analyses (exploratory): linear mixed-effects models for bone level, ISQ/IST and OHIP-14 over time; Kruskal-Wallis for PES; Fisher's exact test for survival. No multiplicity adjustment.
Case-series subset: the first 10 consecutive Group I participants with Elian Type I sockets will also be reported as a prospective proof-of-concept case series limited to peri-implant clinical parameters, clinician-reported outcomes, workflow metrics and complications; it will not report the randomized trial outcomes.
Funding: PowerBone provides 80 implants and prosthetic components free of charge and has no role in design, analysis, interpretation or publication.
- Conditions
- Partial Edentulism, Dental Implant, Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement
- Being tested
- Conventional loading, Monolithic zirconia crown, Permanent 3D-printed PMMA crown, Temporary 3D-printed PMMA crown
- Keywords
- immediate implant placement, immediate loading, 3d printing, monolithic zirconia, Pink Esthetic Score, guided implant surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional loadingProcedure or surgery
Cover screw and 3 months of unloaded healing, then a screw-retained crown in full occlusion.
Monolithic zirconia crownDevice
CAD-CAM milled monolithic zirconia (Zolid fx, Amann Girrbach) screw-retained crown on a Ti-base.
Permanent 3D-printed PMMA crownDevice
DLP-printed (AccuFab D1s) permanent PMMA-based resin crown on a Ti-base.
Temporary 3D-printed PMMA crownDevice
DLP-printed (AccuFab D1s) provisional PMMA-based resin crown on a Ti-base.
| Study group | Role | What they receive |
|---|---|---|
| Group I: Immediate loading - definitive zirconia | Experimental | Immediate guided implant placement; CAD-CAM milled monolithic zirconia (Zolid fx) screw-retained crown delivered within 48 h. Receives: Device: Monolithic zirconia crown |
| Group II: Immediate loading - permanent printed PMMA | Experimental | Same surgery; DLP-printed permanent PMMA crown within 48 h. Receives: Device: Permanent 3D-printed PMMA crown |
| Group III: Immediate loading - temporary printed PMMA | Experimental | Same surgery; DLP-printed provisional PMMA crown within 48 h . Receives: Device: Temporary 3D-printed PMMA crown |
| Group IV: Conventional loading - definitive zirconia (control) | Active comparator | Same surgery; cover screw and 3 months unloaded healing; monolithic zirconia crown in full occlusion at 3 months. Receives: Procedure: Conventional loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant marginal bone level change
Change in distance (mm) from implant platform to first bone-implant contact
Measured: Baseline (implant placement) to 12 months; also measured at 6 months
Secondary outcomes (5)
Implant stability quotient (ISQ)
Resonance frequency analysis with PenguinRFA (Multi Peg)
Measured: Immediately after placement and at 3 months
Implant stability test value (IST)
Damping capacity analysis with Anycheck (Neobiotech)
Measured: Immediately after placement and at 3 months
Implant survival rate
Implant in situ and functional, without mobility, persistent pain, dysaesthesia or infection
Measured: 12 months
Oral health-related quality of life (OHIP-14)
Questionnaire score from 0 to 56
Measured: Baseline, 1 month after definitive crown delivery, 12 months
Pink Esthetic Score (PES)
Seven variables scored 0-2, total 0-14.
Measured: Definitive crown delivery and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start25 Nov 2026 (estimated)
- Primary completion25 Feb 2028 (estimated)
- Study completion25 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial EdentulismStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Principal investigator, Doaa Adel Salah Khattab, Ain Shams University
- Investigators
- Hala Ahmed Abu El-Ela Ahmed, Professor, Study director, Professor of Oral Medicine, Periodontology and Diagnosis, Faculty of Dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882095
- Sponsor's protocol ID
- 17-2026-0006
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data underlying the published results.
Publications
Donker VJJ, Raghoebar GM, Slagter KW, Hentenaar DFM, Vissink A, Meijer HJA. Immediate implant placement with immediate or delayed provisionalization in the maxillary aesthetic zone: A 10-year randomized trial. J Clin Periodontol. 2024 Jun;51(6):722-732. doi: 10.1111/jcpe.13971. Epub 2024 Mar 7.
PubMed 38454548
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Loading Protocol (Immediate vs. Conventional) and Prosthetic Material (Temporary vs. Definitive) on the Clinical Outcomes of Immediately Placed Implants: A Randomized Controlled Comparative Study
- ClinicalTrials.gov ID
- NCT07882095
- Acronym / sponsor ID
- 17-2026-0006
- Conditions
- Partial Edentulism, Dental Implant, Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement
- Keywords
- immediate implant placement, immediate loading, 3d printing, monolithic zirconia, Pink Esthetic Score, guided implant surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 25 Nov 2026 (estimated)
- Primary completion
- 25 Feb 2028 (estimated)
- Study completion
- 25 Mar 2028 (estimated)
- First posted
- 20 Oct 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 randomized controlled trial compares immediate and conventional loading of single implants placed immediately into fresh extraction sockets in the upper front and premolar region. Eighty adults will be randomly assigned to four groups: immediate loading (within 48 hours) with a definitive zirconia crown, a permanent printed PMMA crown, or a temporary printed PMMA crown, or conventional loading with a definitive zirconia crown after 3 months. All implants are placed with a fully guided digital workflow.
Detailed description
Design: parallel-group, four-arm randomized controlled trial at the Faculties of Dentistry of Ain Shams University and Assiut University. Eighty patients requiring single-tooth replacement Planning and surgery: CBCT (Veraview X800) and intraoral scans (Shining 3D Elite) are merged in exoplan for prosthetically driven planning; fully guided surgical guides are DLP-printed. Teeth are extracted flaplessly and PowerBone implants (Ti-6Al-4V, SLA-type surface, internal connection) are placed through the guide. Only implants reaching an insertion torque of at least 35 Ncm proceed; otherwise a wider implant is used or the patient is excluded.
Randomization: computer-generated list held by an investigator not involved in treatment; sequentially numbered, opaque, sealed envelopes are opened only after implant placement.
Prosthetic phase: in Groups I-III a screw-retained crown on a titanium base is delivered within 48 hours in infra-occlusion (no centric or excursive contacts). At 3 months these crowns are replaced with definitive monolithic zirconia crowns in full occlusion. Group IV receives a cover screw and a definitive monolithic zirconia crown in full occlusion at 3 months.
Primary analysis: non-inferiority of Group I vs Group IV for 12-month marginal bone level change, margin 0.5 mm, using the upper limit of the two-sided 95% CI. Per-protocol analysis is primary; intention-to-treat is also reported. Sample size: SD 0.5 mm, one-sided alpha 0.025, power 80% gives 16 per group, increased to 20 per group for dropout.
Secondary analyses (exploratory): linear mixed-effects models for bone level, ISQ/IST and OHIP-14 over time; Kruskal-Wallis for PES; Fisher's exact test for survival. No multiplicity adjustment.
Case-series subset: the first 10 consecutive Group I participants with Elian Type I sockets will also be reported as a prospective proof-of-concept case series limited to peri-implant clinical parameters, clinician-reported outcomes, workflow metrics and complications; it will not report the randomized trial outcomes.
Funding: PowerBone provides 80 implants and prosthetic components free of charge and has no role in design, analysis, interpretation or publication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I: Immediate loading - definitive zirconia | Experimental | Device: Monolithic zirconia crownImmediate guided implant placement; CAD-CAM milled monolithic zirconia (Zolid fx) screw-retained crown delivered within 48 h. |
| Group II: Immediate loading - permanent printed PMMA | Experimental | Device: Permanent 3D-printed PMMA crownSame surgery; DLP-printed permanent PMMA crown within 48 h. |
| Group III: Immediate loading - temporary printed PMMA | Experimental | Device: Temporary 3D-printed PMMA crownSame surgery; DLP-printed provisional PMMA crown within 48 h . |
| Group IV: Conventional loading - definitive zirconia (control) | Active comparator | Procedure: Conventional loadingSame surgery; cover screw and 3 months unloaded healing; monolithic zirconia crown in full occlusion at 3 months. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 21 years or older
- Single tooth requiring extraction and replacement in the maxillary anterior or premolar region (sites 15 to 25), with a gap bounded by natural teeth
- Adjacent tooth present
- Opposing dentition of natural teeth or a fixed tooth- or implant-supported prosthesis
- Extraction socket Elian Type I or Type II
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Systemic or local contraindication to implant treatment
- Smokers
- Current drugs affecting bone metabolism
- Bisphosphonate use in the last 4 years
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 |
|---|---|---|
| Conventional loadingCover screw and 3 months of unloaded healing, then a screw-retained crown in full occlusion. | Procedure or surgery | Group IV: Conventional loading - definitive zirconia (control) |
| Monolithic zirconia crownCAD-CAM milled monolithic zirconia (Zolid fx, Amann Girrbach) screw-retained crown on a Ti-base. | Device | Group I: Immediate loading - definitive zirconia |
| Permanent 3D-printed PMMA crownDLP-printed (AccuFab D1s) permanent PMMA-based resin crown on a Ti-base. | Device | Group II: Immediate loading - permanent printed PMMA |
| Temporary 3D-printed PMMA crownDLP-printed (AccuFab D1s) provisional PMMA-based resin crown on a Ti-base. | Device | Group III: Immediate loading - temporary printed PMMA |
Primary outcome
Peri-implant marginal bone level change
Time frame: Baseline (implant placement) to 12 months; also measured at 6 months
Change in distance (mm) from implant platform to first bone-implant contact
5 secondary outcomes
Implant stability quotient (ISQ)
Time frame: Immediately after placement and at 3 months
Implant stability test value (IST)
Time frame: Immediately after placement and at 3 months
Implant survival rate
Time frame: 12 months
Oral health-related quality of life (OHIP-14)
Time frame: Baseline, 1 month after definitive crown delivery, 12 months
Pink Esthetic Score (PES)
Time frame: Definitive crown delivery and 12 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 20 Oct 2026.
- Background: PubMed 38454548Donker VJJ, Raghoebar GM, Slagter KW, Hentenaar DFM, Vissink A, Meijer HJA. Immediate implant placement with immediate or delayed provisionalization in the maxillary aesthetic zone: A 10-year randomized trial. J Clin Periodontol. 2024 Jun;51(6):722-732. doi: 10.1111/jcpe.13971. Epub 2024 Mar 7.
- Individual participant dataSharing planned: Yes. De-identified individual data underlying the published results.
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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.
Hala Ahmed Abu El-Ela Ahmed, Professor study director
Professor of Oral Medicine, Periodontology and Diagnosis, Faculty of Dentistry, Ain Shams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional loading, Monolithic zirconia crown and Permanent 3D-printed PMMA crown in people with Partial Edentulism and Dental Implant, run by Ain Shams University at 2 sites 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 7 inclusion and 6 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 20 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 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?
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 Kirollos Hany Botros Bernaba, BDs, MSc (+201095409132, kirolloshany@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant marginal bone level change (time frame: Baseline (implant placement) to 12 months; also measured at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07882095, which also lists 1 linked publication.
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 20 Oct 2026.