AzTrials
AzTrials

Bone LossNCT06185283

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

A study testing panoramic x-ray in people with Bone Loss, run by Mansoura University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 45 to 60 years
Conditions the study is for
Bone Loss
What is being tested?
panoramic x-ray
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
No sites listed yet
Study dates
May 2015to Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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

About this study

Official title: Milled in Versus Round Bar for Mini-implant Retained Mandibular Overdentures :A8 Year Retrospective Study of Peri-implant Bone Changes and Posterior Ridge Resorption

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.

Read the detailed description

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 patients were informed about the study objectives and they were signed an informed consent and the protocol were approved by the Ethical Committee, Faculty of Dentistry, Mansoura University.

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.

Patients' criteria:

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). 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 .For each patient, overdentures assisted by four splinted mini dental implants According to type of bar attachment used for splinting the four MDIs, patients were divided into two equal groups where: Group I: Received milled-in bar and Group II: Received round bar joint attachment. O-Ball impression copings were snapped directly onto each O-Ball MDI Implant. 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 Bar construction

Milled-in bar construction for group I:

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). After casting into cobalt chromium alloy, the metal bar was secured into position on the cast and adjusted to the table of the milling machine. The facial and lingual guide planes were refined and the bar was finished and polished to a high shine.

Round bar fabrication for group II:

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.

For group I: Metallic Retentive clips were directly fastened to the bar. After the occlusion was rechecked, the clips were picked-up using auto-polymerized acrylic resin while the patient was instructed to close lightly in centric occlusion.

For group II: 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.

The prosthodontic maintenance required for the IODs and opposing dentures were evaluated during a 8-year follow-up period and compared between the 2 bar design attachments for IODs.

Patients' evaluation

Radiographic Evaluation of peri-implani bone changes:

  1. Long cone paralleling technique and a film holder designed specifically for implant imaging will be used for intraoral radiograph. To maintain the same film- implant distance and cone implant distance, a modification will be carried out for the film holder. This modification is a hole drilled exactly above the implant fixture so the distance will be maintained during subsequent film exposures. Through this modification, standardized radiographs will be achieved.
  2. The long cone periapical radiographs will be taken using a digital photostimulable phosphor plate (PSP) aligned parallel to the implant and all radiographs will be taken by the same standard intraoral X-ray machine with exposure settings of 60 kV, 7 mA for 0.16 s. Subsequently, lines and reference points will be marked. Detect magnification error by comparing the implant dimensions in the radiographs with the actual implant dimensions this ratio allow us to obtain the actual values of the bone changes.
  3. 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) will be calculated by subtracting DIB at (T8) from DIB at T0. Alveolar bone changes will be measured mesially and distally. B. periapical x-ray will be done immediately at insertion (T0) ,the second one (T3), and after 8 years following the insertion (T8).

Evaluation of Posterior Mandibular Alveolar Bone Changes:

Posterior area index will be evaluated by proportional measurement of a posterior mandibular area like the method described by Wright and Watson. Two panoramic radiographs will be taken, one at time of insertion (T0) and the second one after 8 years following the insertion (T8). The reference points and lines will traced using AutoCAD 2018 software.

The posterior mandibular area will outline by joining points at the gonion (G/G') to the lower border of the mental foramen (M/M') and the sigmoid notch (S/S'). (N/N') representing the center of the triangle joining the three points M-S-G/M'-S'-G'. Reference area will be represented by a line joining M-G-N/M'-G'-N'. The experimental area will determined A-P-G-M/A'-P'-G'-M' where A-L/A'-L' represents the crest of the mandibular ridge to the lower border of the mandible and perpendicular to the M-G/M'G' line. The area difference which represents the bone resorption will be calculated by the equation (X/Y+X'/Y')/2 where X/X' represents the experimental area and Y/Y' represents the reference area.

Conditions
Bone Loss
Being tested
panoramic x-ray
Keywords
milled bar, round bar
Medical subject headings
Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • panoramic x-rayDiagnostic test

    Also called periapical x-ray

    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.

Study groups in NCT06185283
Study groupRoleWhat they receive
milled bar groupOther. 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).
Receives: Diagnostic Test: panoramic x-ray
round barOtherPrefabricated 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.
Receives: Diagnostic Test: panoramic x-ray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 8 year

  2. posterior ridge resorption

    for posterior area in mandible

    Measured: 8 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2023
  2. Study startMay 2015
  3. Primary completion11 Apr 2020
  4. Study completionSep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06185283
Sponsor's protocol ID
M01010023RP
Status last verified
Nov 2023
First submitted
3 Dec 2023
Last updated
29 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19912482
  • 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.

    PubMed 40818957

Questions about this trial

What is this clinical trial studying?

A study testing panoramic x-ray in people with Bone Loss, run by Mansoura University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

peri-implant bone loss (time frame: 8 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06185283, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in