3D -Printed Single Implant Overdentures

Edentulous Mouth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366895
• Other study ID #: MSA
• Status: Completed
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: August 21, 2022

Study information

• Verified date: November 2022
• Source: October University for Modern Sciences and Arts
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 21, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Edentulous Mouth
• Mouth, Edentulous

Intervention

Other:
• conventional single implant overdenture
conventional manufactured implant overdenture
• 3d printed single implant overdenture
CAD-CAM manufactured implant overdenture.

Locations

Country	Name	City	State
Egypt	Msa Uni	Giza

Sponsors (1)

Lead Sponsor	Collaborator
October University for Modern Sciences and Arts

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival	The implants were considered surviving if they were clinically stable, functioning without any mobility	1 year
Secondary	Survival rate of overdentures	urvival rate of overdentures: (calculated by Incidence of mid-line fracture)	1 year
Secondary	maximum biting force (MBF)	MBF was achieved bilaterally using Flexiforce A 301® force sensor and Arduino microcontroller with a crystal displa	1 year