Effect of Two Different Digital Construction Techniques of Implant-assisted Overdentures

NCT06720389 | Completed DMC FDA Device

• 1 other identifier: A01010024RP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

twenty patients received mandibular overdenture constructed by different construction techniques were classified equally and randomly into two groups peri implant bone loss was assessed by CBCT at baseline (T0), at1 year(T1), at 3 years(T3) and posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

Conditions

Peri Implant Bone Loss

Keywords

Milled denture base; 3D-printing denture base,

Outcome Measures

Primary Outcomes (2)

• peri implant bone loss

  peri implant bone loss was assessed by CBCT

  at baseline (T0), at1 year(T1), at 3 years(T3)

• posterior ridge resorption

  posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

  at baseline (T0), at 1 year( T1), at 3 years (T3).

Study Arms (2)

milled mandibular overdenture opposed by maxillary complete denture

ACTIVE COMPARATOR

A denture base milled from a pre-polymerized block of polymethylmethacrylate (Ivobase CAD) along with milled denture teeth from a block of tooth coloured material PMMA (SR Vivodent CAD).

Radiation: peri implant bone loss was assessed by CBCT; Other: posterior ridge resorption was assessed by CBCT

3D-Printed mandibular overdenture

ACTIVE COMPARATOR

The printer (Rasdent 3d printer) was loaded with material of 3D-printed denture base and 3D- printed denture teeth (Dentca denture teeth shade A2). The mandibular denture teeth were printed as one unit then bonded to the lower printed denture base.

Radiation: peri implant bone loss was assessed by CBCT; Other: posterior ridge resorption was assessed by CBCT

Interventions

peri implant bone loss was assessed by CBCT RADIATION

using CBCT, vertical bone loss (VBL) was measured at baseline (T0), at1 year(T1), at 3 years(T3)

3D-Printed mandibular overdenture; milled mandibular overdenture opposed by maxillary complete denture

posterior ridge resorption was assessed by CBCT OTHER

posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.

3D-Printed mandibular overdenture; milled mandibular overdenture opposed by maxillary complete denture

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patient wearing maxillary conventional denture.
• All patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago.
• A Cone Beam Computed Tomography (CBCT) done to verify the accurate position and success of the inserted implant.
• They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
• At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna). This was detected by a tentative jaw relation.
• All patients are of angel's class I maxillo-mandibular relationships.

You may not qualify if:

• Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
• Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
• Long term immunosuppress and corticosteroid drug therapy.
• Patient with abnormal habits as clenching and bruxism.
• Smoking patient.
• Uncooperative patients.
• Neuromuscular diseases.
• Patient with problems in TMJ.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Egypt

Location

Related Publications (1)

• El Khamisy NES, Emera RMK, Elmanci TM, Aboelez MA. Effect of two different digital construction techniques of mandibular implant-assisted overdentures on peri-implant bone loss and posterior ridge resorption: a 3-year prospective randomized clinical trial. BMC Oral Health. 2025 Jul 2;25(1):1040. doi: 10.1186/s12903-025-06425-0.

  PMID: 40604700 DERIVED

Study Design

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

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: October 12, 2022
• Primary Completion: August 4, 2024
• Study Completion: November 6, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)