search
Back to results

3D -Printed Single Implant Overdentures

Primary Purpose

Edentulous Mouth

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
conventional single implant overdenture
3d printed single implant overdenture
Sponsored by
October University for Modern Sciences and Arts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Mouth

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Msa Uni

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

control

intervention

Arm Description

Participants in control group (Group-A) received conventional manufactured implant overdenture

participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.

Outcomes

Primary Outcome Measures

Implant survival
The implants were considered surviving if they were clinically stable, functioning without any mobility

Secondary Outcome Measures

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

Full Information

First Posted
April 21, 2020
Last Updated
November 6, 2022
Sponsor
October University for Modern Sciences and Arts
search

1. Study Identification

Unique Protocol Identification Number
NCT04366895
Brief Title
3D -Printed Single Implant Overdentures
Official Title
3D Printing/Additive Manufacturing of Single- Implant Overdentures. A Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
August 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October University for Modern Sciences and Arts

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Mouth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Experimental
Arm Description
Participants in control group (Group-A) received conventional manufactured implant overdenture
Arm Title
intervention
Arm Type
Experimental
Arm Description
participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.
Intervention Type
Other
Intervention Name(s)
conventional single implant overdenture
Intervention Description
conventional manufactured implant overdenture
Intervention Type
Other
Intervention Name(s)
3d printed single implant overdenture
Intervention Description
CAD-CAM manufactured implant overdenture.
Primary Outcome Measure Information:
Title
Implant survival
Description
The implants were considered surviving if they were clinically stable, functioning without any mobility
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Survival rate of overdentures
Description
urvival rate of overdentures: (calculated by Incidence of mid-line fracture)
Time Frame
1 year
Title
maximum biting force (MBF)
Description
MBF was achieved bilaterally using Flexiforce A 301® force sensor and Arduino microcontroller with a crystal displa
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Elawady, PHD
Organizational Affiliation
Lecturer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Msa Uni
City
Giza
ZIP/Postal Code
12451
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

3D -Printed Single Implant Overdentures

We'll reach out to this number within 24 hrs