Milled in Versus Round Bar for Mini-implant Retained Mandibular Overdentures

NCT06185283 | Completed

• 1 other identifier: M01010023RP
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

purpose: The primary purpose of this retrospective radiographic study were conducted to compare between milled bar and round bar for mini implant retained overdentures (IODs) on peri-implant bone changes and posterior mandibular ridge resorption .Study Design: A convenience sample of 18 completely edentulous participants were selected for this retrospective study from patients originally available at the start of the trial . The null hypothesis was that there were no significant difference between milled in and round bar attachment retained implant supported overdentures in posterior ridge resorption and peri-implant bone changes.

Conditions

Bone Loss

Keywords

milled bar; round bar

Outcome Measures

Primary Outcomes (2)

• peri-implant bone loss

  For marginal alveolar bone changes, the distance between implant shoulder (A) and first bone to implant contact (B) indicated vertical bone level (DIB) in mm. Vertical bone loss (VBL) were calculated by subtracting DIB at (T8) from DIB at T0. Alveolar bone changes were measured mesially and distally. B. periapical x-ray were done immediately at insertion (T0) ,the second one (T3) Two panoramic radiographs were taken, one at time of insertion (T0) and the second one after 8 years following the insertion (T8). The reference points and lines were traced using AutoCAD 2018 software

  8 year

• posterior ridge resorption

  for posterior area in mandible

  8 year

Study Arms (2)

milled bar group

OTHER

. O-Ball impression copings were snapped directly onto each O-Ball mini dental Implants. A Pick-Up closed tray impression technique was made using polyether impression material. MDI Lab Analog was pressed into the coping until a snap fit was observed .The impression was poured into dental stone to form a stone model for scanning The cast was scanned using 3SHAPE TRIOS and the bar constructed throughout the production steps: Step 1: Order Creation ,Step 2: scan the lab analog of MDI on the stone model scanned with D700 scanner. Step 3: CAD Designing (first select preparation in teeth view from canine to canine-click abutment button-choose restoration type (bar)-choose restoration material (wax) .Step 4: Sending to CAM for Manufacturing, Step 5: Manufacturing (cutting from disc of modeling wax).

Diagnostic Test: panoramic x-ray

round bar

OTHER

Prefabricated plastic bar pattern (RHIN 83 OT BAR multi use) was pre scanned for standardization of all cases. After cast scanning the abutment copy was designed and again standardized for all MDI. The pre scanned bar was inserted over the copies. The same procedure for manufacturing was followed as that of milled -in bar. The finished bar is brought to the patient's mouth, seated accurately. The denture is then tried, fitted and extensions adjusted in the usual manner. The denture fitting surface was; the hygienic space under the bar was blocked-out with wax. plastic clip was adapted to their metal sleeve, adapted to the bar, the occlusion was checked and then they were picked-up using auto-polymerized acrylic resin while the patient was instructed to close lightly in centric occlusion. After finishing and polishing procedures, the mandibular denture was clinically remounted to adjust any interferences in the centric and eccentric the occlusal contacts.

Diagnostic Test: panoramic x-ray

Interventions

panoramic x-ray DIAGNOSTIC_TEST

Long cone paralleling technique and a film holder designed specifically for implant imaging were used for intraoral radiograph. To maintain the same film- implant distance and cone implant distance, a modification were carried out for the film holder. This modification is a hole drilled exactly above the implant fixture so the distance were maintained during subsequent film exposures. Through this modification, standardized radiographs were achieved.

Also known as: periapical x-ray

milled bar group; round bar

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Completely edentulous maxillary and mandibular residual alveolar ridges covered with healthy mucosa without any remaining roots or local inflammation as detected by digital panoramic x-ray and clinical examination.. Anterior mandibular bone length was sufficient to allow proper implant placement as assessed by digital panoramic radiograph. Patients were of class I Angel's maxillo-mandibular relation with at least 22mm of restorative space allow for bar construction as detected by tentative jaw relation, and good bone quality (classes 1 to 3 according to Lekholm and Zarb).

You may not qualify if:

• Participants with diabetes mellitus, osteoporosis, immunological dysfunction, anticoagulant medication, radiation to the head and neck region, smoking habits ,and systemic diseases that interfere with implants osseointegration were excluded from the study

Sponsors & Collaborators

• Mansoura University: lead

Related Publications (2)

• Fromentin O, Lassauzay C, Abi Nader S, Feine J, de Albuquerque Junior RF. Testing the retention of attachments for implant overdentures - validation of an original force measurement system. J Oral Rehabil. 2010 Jan;37(1):54-62. doi: 10.1111/j.1365-2842.2009.02020.x. Epub 2009 Nov 11.

  PMID: 19912482 BACKGROUND

• El-Khamisy NES, Emera RMK, Awad HN. Milled in versus round bar for mini implant retained mandibular overdentures: a 8-year retrospective radiographic study of peri-implant bone changes and posterior ridge resorption. BMC Oral Health. 2025 Aug 16;25(1):1334. doi: 10.1186/s12903-025-06689-6.

  PMID: 40818957 DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nermeen E Elkhamisy, Phd

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A convenience sample of 18 completely edentulous participants were selected for this retrospective study from patients originally available at the start of the trial . The patients were equally divided into two groups at the start of the trial. The patients (average age 45-60 years) were selected for this study from outpatient clinic of Removable Prosthodontics Department, Faculty of Dentistry, Mansoura University

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 29, 2023
• Study Start: May 1, 2015
• Primary Completion: April 11, 2020
• Study Completion: September 1, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share