This Study Aims to Evaluate the Soft Tissue Response and Prosthetic Complications Associated With Three Different Types of Provisional Prosthesis Used in Immediate Loading Full-arch Implant Prosthetic Treatment. The Patients Are Randomly Assigned to the Three Groups to Compare the Clinical Outcomes

February 3, 2026 updated by: Mansoura University

Evaluation of Soft Tissue Response and Prosthetic Complication of Three Different Provisional Prosthesis Used for Immediate Load Full Arch Implant Prosthesis. Randomized Control Clinical Trial

This study aims to evaluate the soft tissue response and prosthetic complications associated with three different types of provisional prostheses used in immediate loading full-arch implant prosthetic treatment. The patients are randomly assigned to the three groups to compare the clinical outcomes and determine which provisional prosthesis provides better soft tissue health and fewer prosthetic complications

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

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
      • Al Mansurah, Egypt, 35511
        • Mansoura university faculty of dentistry

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- In good general health. Controlled systemic diseases such as well-managed diabetes or hypertension. Good oral hygiene Adequate bone quality and quantity (Type I-III bone, ≥10mm height, ≥6mm width).

Exclusion Criteria:

  • Uncontrolled systemic diseases Bone insufficiency Active infection or periodontal disease. Pregnancy. Heavy smokers (>10 cigarettes/day). History of previous implant failure in the same site. Immunocompromised patients (e.g., HIV, recent radiation therapy

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Printed provisional
patients received 3D printed provisional full arch prosthesis
Device: 3D printed provisional full arch prosthesis
patients received 3D printed provisional full arch prosthesis after implant placement
Experimental: Bar reinforced provisional
patients received Bar reinforced 3D printed provisional full arch prosthesis.
Device: Bar reinforced 3D printed provisional full arch prosthesis
patients received bar reinforced 3D printed provisional full arch prosthesis after implant placement
Experimental: Milled provisional
patient received Milled PMMA provisional full arch prosthesis.
Device: Milled PMMA provisional full arch prosthesis
patients received Milled PMMA provisional full arch prosthesis after implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical evaluation of dental implant (bone Level)
Time Frame: 3 months
Evaluation included alveolar bone level around implant which is evaluated using periapical x-rays comparing T0 (at implant insertion) to T1 ( at one and half month) and T2 (at three months ) measuring amount of bone resorption around implant
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified plaque index
Time Frame: 3 months
the Modified Plaque Index (MPI) to assess peri-implant biofilm at four surfaces using scores from 0 (no plaque) to 3 (abundant plaque) using periodontal probe.
3 months
the Modified Gingival Index (MGI)
Time Frame: 3 months
evaluate peri-implant soft tissue inflammation, scored from 0 (healthy mucosa) to 3 (severe inflammation)
3 months
peri-implant probing depth (PD)
Time Frame: 3 months
measured with pressure-sensitive probes, where an increase over time indicates possible bone loss, with an ideal sulcus depth of less than 5 mm to allow effective oral hygiene
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)

February 1, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

January 10, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • A08012024RP

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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