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

NCT06929689 | Completed

• 1 other identifier: all-on-three
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Prosthesis; Dental Implant

Keywords

Three implants; Fixed detachable restorations

Outcome Measures

Primary Outcomes (4)

• Radiographic evaluation

  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.

  12 months

• Peri-Implant Probing Depth (PIPD)

  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.

  12 months

• Clinical Attachment level (CAL)

  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.

  12 months

• Implant stability

  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.

  12 months

Study Arms (1)

completely edentulous patients

EXPERIMENTAL

fixed detachable restorations on three dental implants in the mandible

Procedure: three dental implants

Interventions

three dental implants PROCEDURE

fixed detachable prosthesis

completely edentulous patients

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21526, Egypt

Location

Study Officials

• Ahmed M Abdelhamid, PhD

  Alexandria University

  STUDY CHAIR

• Enaya Sharara, PhD

  Alexandria University

  STUDY CHAIR

• Rania A Fahmy, PhD

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer at Removable Prosthodontics Department, Faculty of Dentistry, Pharos University, Alexandria, Egypt

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: March 19, 2022
• Primary Completion: June 8, 2023
• Study Completion: February 9, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

EG (1)