3D -Printed Single Implant Overdentures

Not Applicable

Completed

• Conditions: Edentulous Mouth
• Interventions: Other: conventional single implant overdenture; Other: 3d printed single implant overdenture

• Registration Number: NCT04366895
• Lead Sponsor: October University for Modern Sciences and Arts

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.

Study Timeline

• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-25
• Study First Posted: 2020-04-29
• Study Start: 2021-01-20
• Primary Completion: 2022-06-20
• Study Completion: 2022-08-21
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-06
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	conventional single implant overdenture	Participants in control group (Group-A) received conventional manufactured implant overdenture
intervention	3d printed single implant overdenture	participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.

Primary Outcome Measures

Name	Time	Method
Implant survival	1 year	The implants were considered surviving if they were clinically stable, functioning without any mobility

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Msa Uni; 🇪🇬 Giza, Egypt