An interventional study of Conventional loading and Monolithic zirconia crown in Partial Edentulism, Dental Implant and Tooth Loss in the Esthetic Zone Requiring Immediate Implant Placement, sponsored by Ain Shams University. Not yet recruiting at 2 sites in Egypt. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
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.
Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Immediate guided implant placement; CAD-CAM milled monolithic zirconia (Zolid fx) screw-retained crown delivered within 48 h.
Device: Monolithic zirconia crown
Same surgery; DLP-printed permanent PMMA crown within 48 h.
Device: Permanent 3D-printed PMMA crown
Same surgery; DLP-printed provisional PMMA crown within 48 h .
Device: Temporary 3D-printed PMMA crown
Same surgery; cover screw and 3 months unloaded healing; monolithic zirconia crown in full occlusion at 3 months.
Procedure: Conventional loading
Cover screw and 3 months of unloaded healing, then a screw-retained crown in full occlusion.
CAD-CAM milled monolithic zirconia (Zolid fx, Amann Girrbach) screw-retained crown on a Ti-base.
DLP-printed (AccuFab D1s) permanent PMMA-based resin crown on a Ti-base.
DLP-printed (AccuFab D1s) provisional PMMA-based resin crown on a Ti-base.
Peri-implant marginal bone level change
Change in distance (mm) from implant platform to first bone-implant contact
Time frame: Baseline (implant placement) to 12 months; also measured at 6 months
Implant stability quotient (ISQ)
Resonance frequency analysis with PenguinRFA (Multi Peg)
Time frame: Immediately after placement and at 3 months
Implant stability test value (IST)
Damping capacity analysis with Anycheck (Neobiotech)
Time frame: Immediately after placement and at 3 months
Implant survival rate
Implant in situ and functional, without mobility, persistent pain, dysaesthesia or infection
Time frame: 12 months
Oral health-related quality of life (OHIP-14)
Questionnaire score from 0 to 56
Time frame: Baseline, 1 month after definitive crown delivery, 12 months
Pink Esthetic Score (PES)
Seven variables scored 0-2, total 0-14.
Time frame: Definitive crown delivery and 12 months
Bleeding on probing
% of sites
Time frame: 3-4 weeks after crown delivery, 6 and 12 months
Plaque control record
% of sites
Time frame: 3-4 weeks after crown delivery, 6 and 12 months
Technical and biological complications
Screw loosening/fracture, chipping/fracture, contact loss, retention loss, mucositis, peri-implantitis, dehiscence, adverse events; counts per group
Time frame: Through 6 months
Clinician-rated ease of crown delivery
Numerical rating scale 0 (extremely easy) to 10 (extremely difficult)
Time frame: At initial crown delivery
Plan to share: Yes — De-identified individual data underlying the published results.
Supporting information: Study protocol, Statistical analysis plan
Time frame: From publication, for 5 years
Access criteria: Reasonable request to the principal investigator with a methodologically sound proposal.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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