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NCT Number: NCT07700771

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

3D-Printed Resin Provisional Crown

Procedure

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 Crown

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Influence of Provisional Restoration Type on Clinical Outcomes of Fully Digital Single-Visit Immediate Implant Placement and Loading: A Randomized Clinical Trial

Acronym: PRODIGI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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