3D -Printed Single Implant Overdentures

NCT ID: NCT04366895

Last Updated: 2022-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-20

Study Completion Date

2022-08-21

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.

Conditions

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Edentulous Mouth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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control

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

Group Type EXPERIMENTAL

conventional single implant overdenture

Intervention Type OTHER

conventional manufactured implant overdenture

intervention

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

Group Type EXPERIMENTAL

3d printed single implant overdenture

Intervention Type OTHER

CAD-CAM manufactured implant overdenture.

Interventions

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conventional single implant overdenture

conventional manufactured implant overdenture

Intervention Type OTHER

3d printed single implant overdenture

CAD-CAM manufactured implant overdenture.

Intervention Type OTHER

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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October University for Modern Sciences and Arts

OTHER

Sponsor Role lead

Responsible Party

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Dina ElAwady

lecturer of Prosthodontics (principal investigator)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina Elawady, PHD

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Locations

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Msa Uni

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MSA

Identifier Type: -

Identifier Source: org_study_id

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