NCT07700771

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 8, 2026

Last Update Submit

July 21, 2026

Conditions

Tooth Loss in the Esthetic Zone Requiring Immediate Implant PlacementImmediate Dental Implant PlacementImmediate LoadingProvisional RestorationDigital Implant Dentistry

Keywords

Immediate implant placementImmediate loadingDigital workflowGuided implant surgeryProvisional restoration3D-printed resinCAD/CAM-milled PMMAMaxillary esthetic zoneCustomized healing abutmentPeri-implant soft tissue

Outcome Measures

Primary Outcomes (1)

  • Peri-implant soft tissue changes

    Soft tissue contour and peri-implant tissue condition will be assessed using digital intraoral scanning (STL files) using superimposition.

    Baseline (immediately after provisionalization), 1 month, 3 months, and 6 months postoperatively.

Secondary Outcomes (2)

  • Pink Esthetic Score (PES)

    After 3 and 6 months postoperatively.

  • Implant stability

    Immediate post-operative and at 3 months.

Study Arms (2)

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.

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.

Procedure: CAD/CAM-Milled PMMA Provisional Crown

Interventions

3D-Printed Resin Provisional CrownPROCEDURE

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.

Study Group 1 (3D-Printed resin Group)
CAD/CAM-Milled PMMA Provisional CrownPROCEDURE

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 2 (CAD/CAM-Milled PMMA Group)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2026

First Posted

July 14, 2026

Study Start

December 1, 2025

Primary Completion

June 30, 2026

Study Completion

July 1, 2026

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)