3D -Printed Single Implant Overdentures

3D Printing/Additive Manufacturing of Single- Implant Overdentures. A Randomized Controlled Clinical Trial.

A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of 14 participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.

Study Overview

• Status: Completed
• Conditions: Edentulous Mouth
• Intervention / Treatment: Other: conventional single implant overdenture; Other: 3d printed single implant overdenture

Detailed Description

Introduction: Mandibular single implant overdenture is a well-established treatment modality that address limited financial resources of patients and simultaneously enabled the management of conventional complete denture problems. CAD/CAM technology helped to mitigate the problems encountered with conventional fabrication techniques, which results in improved dentures fit and retention. Therefore, the aim of the current trial study was to evaluate whether overdentures fabricated using CAD/CAM printed technology exhibited improved patient satisfaction, denture retention, implant survival rate and decreased post-insertion maintenance or not compared to overdentures manufactured using conventional techniques.

Methods: A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of seven participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12451
    • Msa Uni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

inclusion criteria

• the participant should be completely edentulous ranging in age from 35 to 75 years
• Angle's class I skeletal relationship
• normal facial symmetry
• adequate inter-arch space not less than 12mm
• should be a cooperative patient -

Exclusion Criteria:

• temporomandibular disorders
• uncontrolled diabetes
• bleeding disorders or anticoagulant therapy
• flabby tissues or sharp mandibular residual ridge
• neuromuscular disorders
• Angle's class II and III skeletal relationship.
• Patients who were heavy smokers
• chemotherapy or radiotherapy or with severe psychiatric disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: control; Participants in control group (Group-A) received conventional manufactured implant overdenture	Other: conventional single implant overdenture; conventional manufactured implant overdenture
Experimental: intervention; participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.	Other: 3d printed single implant overdenture; CAD-CAM manufactured implant overdenture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival	The implants were considered surviving if they were clinically stable, functioning without any mobility	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate of overdentures	urvival rate of overdentures: (calculated by Incidence of mid-line fracture)	1 year
maximum biting force (MBF)	MBF was achieved bilaterally using Flexiforce A 301® force sensor and Arduino microcontroller with a crystal displa	1 year

Collaborators and Investigators

• Sponsor: October University for Modern Sciences and Arts
• Investigators: Principal Investigator: Dina Elawady, PHD, lecturer

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): August 21, 2022

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 25, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: MSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No