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OpenTrials
Completed

NCT Number: NCT07395167

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

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

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Key information

Conditions

Immediate Provisional Prosthesis

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university faculty of dentistry

Al Mansurah, 35511, Egypt

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

3D printed provisional full arch prosthesis

Device

patients received 3D printed provisional full arch prosthesis after implant placement

Bar reinforced 3D printed provisional full arch prosthesis

Device

patients received bar reinforced 3D printed provisional full arch prosthesis after implant placement

Milled PMMA provisional full arch prosthesis

Device

patients received Milled PMMA provisional full arch prosthesis after implant placement

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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. 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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 9, 2026
Registry last updated
Feb 9, 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.