Influence of Provisional Restoration Type on Outcomes of Immediate Implant Placement and Loading (PRODIGI)

July 8, 2026 updated by: Mansoura University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia Governorate
      • Al Mansurah, Dakahlia Governorate, Egypt
        • Faculty of Dentistry Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Patients presenting with non-restorable teeth in the maxillary esthetic zone indicated for extraction and immediate implant placement.

    2. Age ranging from 18 to 50 years. 3. Adequate interarch relationship and interocclusal space to accommodate the planned prosthetic restoration.

    4. 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.

    5. Good oral hygiene and periodontal health. 6. Willingness to attend all follow-up visits and comply with study requirements.

Exclusion Criteria:

  • 1. Presence of acute infection, pathological lesions, or severe periodontal disease at the planned implant site.

    2. Smokers. 3. Alcohol or drug abuse. 4. Patients with systemic conditions contraindicating implant surgery (e.g., uncontrolled diabetes mellitus, bleeding disorders, immunosuppression, recent radiotherapy to the head and neck region).

    5. Pregnancy or lactation. 6. Patients with parafunctional habits such as bruxism or clenching. 7. Inability to maintain adequate oral hygiene or attend follow-up visits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group 1 (3D-Printed resin Group)
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 placementin the maxillary esthetic zone.
Procedure: 3D-Printed Resin Provisional Crown
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.
Experimental: Study Group 2 (CAD/CAM-Milled PMMA Group)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (immediately after provisionalization), 1 month, 3 months, and 6 months postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pink Esthetic Score (PES)
Time Frame: After 3 and 6 months postoperatively.
Peri-implant soft tissue esthetics were assessed using the Pink Esthetic Score (0-14). Higher scores indicated better esthetic outcomes.
After 3 and 6 months postoperatively.
Implant stability
Time Frame: Immediate post-operative and at 3 months.
Implant stability will be evaluated using Osstell device based on resonance frequency analysis (ISQ values).
Immediate post-operative and at 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Actual)

June 30, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R.26.06.127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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