3D -Printed Single Implant Overdentures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Edentulous Mouth

Intervention / Treatment
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* Other: conventional single implant overdenture
* Other: 3d printed single implant overdenture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |