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3D -Printed Single Implant Overdentures

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04366895
Enrollment
28
Registered
2020-04-29
Start date
2021-01-20
Completion date
2022-08-21
Last updated
2022-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Mouth

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.

Interventions

OTHERconventional single implant overdenture

conventional manufactured implant overdenture

OTHER3d printed single implant overdenture

CAD-CAM manufactured implant overdenture.

Sponsors

October University for Modern Sciences and Arts
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Implant survival1 yearThe implants were considered surviving if they were clinically stable, functioning without any mobility

Secondary

MeasureTime frameDescription
Survival rate of overdentures1 yearurvival rate of overdentures: (calculated by Incidence of mid-line fracture)
maximum biting force (MBF)1 yearMBF was achieved bilaterally using Flexiforce A 301® force sensor and Arduino microcontroller with a crystal displa

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026