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Completed

NCT Number: NCT06929689

Evaluation of the All-on-three Concept in Mandible.

Evaluation of the clinical and radiographic treatment outcomes of immediately loaded three implants by fixed-detachable prostheses for the management of totally edentulous mandibles.

The hypothesis is that mandibular immediately loaded fixed detachable restorations supported only by three implants in the inter-foraminal region will not adversely affect the clinical or radiographical treatment outcome.

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Key information

Conditions

Dental Prosthesis Dental Implant

Age range

40 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21526, Egypt

About this study

The ideal amount of implants for edentulous mandible rehabilitation continues to be a subject of scholarly debate. Traditionally, at least four implants are required for fixed detachable prostheses, but increasing implant numbers raises costs and complexity, leading to patient reluctance. Reducing the number to three implants may simplify surgery, minimize trauma, and encourage patient acceptance.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Completely edentulous patients with skeletal Class I maxilla-mandibular relationship.
  • Adequate inter-arch space (22 mm), measured using the "try in" before any intervention.
  • Male or female patients aged between 40 and 60 years.
  • Maxillary and mandibular ridges with no history of recent extraction.
  • Mandibular ridge should be ≥15 mm in height and ≥7 mm in width to accommodate three implants in the intra-foramina area of the mandibular arch, verified by using cone beam computed tomography (CBCT).

Exclusion criteria

  • History of radiotherapy in the head and neck region.
  • History of hard tissue augmentation.
  • Presence of any intra-oral pathological condition.
  • Any medical disorder that could complicate the surgical phase or affect osseointegration, such as osteoporosis, uncontrolled diabetes, and hypertension.
  • Smoker and bruxer patients.

Treatment and study plan

three dental implants

Procedure

fixed detachable prosthesis

Primary outcomes

  1. Radiographic evaluation

    Time frame: 12 months

    The level of alveolar bone around each implant was evaluated using CBCT. Radiographic assessment of the vertical bone change around each implant was measured and the mean value was calculated. Bone measurements was evaluated at the insertion time then it was evaluated regularly 6 months and 12 months.

  2. Peri-Implant Probing Depth (PIPD)

    Time frame: 12 months

    Peri-implant probing depth refers to the distance between the gingival margin and the most apically probable portion in millimeters (mm). The peri-implant sulcus depth was measured using a graduated plastic periodontal probe. The probe was held parallel to the long axis of the implant and introduced to the peri-implant sulcus with slight pressure. Measurements was made at four sites around each implant; buccal, lingual, mesial and distal. Probing depth of 1 mm or less was recorded as "1mm", and those exceeding 1 mm but less than 2 mm was recorded as "2mm" and so forth. The mean records for each implant was then calculated.

  3. Clinical Attachment level (CAL)

    Time frame: 12 months

    It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters. Assessment of the clinical attachment level was performed simultaneously while measuring the peri-implant probing depth.

  4. Implant stability

    Time frame: 12 months

    Mobility (implant stability) was measured by using RFA (Osstell device instrument). The Osstell unit record numeric value of 1-100 which is referred to as the implant stability quotient (ISQ). The larger the ISQ value recorded indicates the more stable the implant-bone interface. Initial stability was checked at the insertion time then it was evaluated regularly, 6 months and 12 months.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of All-on-three Immediately Loaded Mandibular Fixed Detachable Restorations (a Clinical Trial)

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

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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