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

Not Applicable

Completed

• Conditions: Dental Prosthesis; Dental Implant

• Registration Number: NCT06929689
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-03-19
• Primary Completion: 2023-06-08
• Study Completion: 2025-02-09
• Status Verified: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Radiographic evaluation	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.
Clinical Attachment level (CAL)	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.
Peri-Implant Probing Depth (PIPD)	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.
Implant stability	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt