Comparison of Denture Base Adaptation and Per-iimplant Tissue Health Between CAD and CAM Implant Overdenture

NCT ID: NCT06166446

Last Updated: 2023-12-21

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

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2023-02-02

Brief Summary

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Background: Complete overdenture manufacturing has been greatly developed using computer-aided designing and computer-aided manufacturing (CAD-CAM) technology.

Material and method: 15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. The first group received a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture, while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic complete denture. Peri-implant soft tissue and denture adaptation were evaluated using clinical parameters

Detailed Description

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Background: In recent years, complete overdenture manufacturing has been greatly developed using computer-aided designing and computer-aided manufacturing (CAD-CAM) technology. This clinical study compared the soft tissue health between CAD/CAM-milled and 3D-printed implants that retained complete overdentures.

Material and method: 15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. The first group received a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture, while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic complete denture. Peri-implant soft tissue was evaluated using clinical parameters including the gingival index, plaque index, bleeding index, and probing depth at the time of mandibular complete overdenture insertion (T0), six months (T6), and twelve months (T12) of denture use.

Conditions

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Periimplantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

15 completely edentulous patients, divided into two groups, received two implants in the mandibular canine area with ball attachment. The first group received a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture, while the second group received a 3D-printed mandibular overdenture and a maxillary acrylic complete denture. Peri-implant soft tissue was evaluated using clinical parameters including the gingival index, plaque index, bleeding index, and probing depth at the time of mandibular complete overdenture insertion (T0), six months (T6), and twelve months (T12) of denture use.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture

patients received lower denture fabricated by milling technique

Group Type ACTIVE_COMPARATOR

subtractive technique

Intervention Type DEVICE

The milled denture teeth are then bonded into the milled recesses using a special PMMA bonding system.

3rd printed mandibular overdenture and a maxillary acrylic conventional complete denture

The denture base was fabricated by adding the material layer by layer

Group Type ACTIVE_COMPARATOR

additive technique

Intervention Type DEVICE

The denture teeth were printed as one unit using the same method with tooth resin (DENTCA Denture Tooth, Shade A2).

Interventions

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subtractive technique

The milled denture teeth are then bonded into the milled recesses using a special PMMA bonding system.

Intervention Type DEVICE

additive technique

The denture teeth were printed as one unit using the same method with tooth resin (DENTCA Denture Tooth, Shade A2).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

poor denture adaptation co-operative patients

Exclusion Criteria

metabolic diseases uncontrolled diabetes osteoporosis and hyperparathyroidism.
Minimum Eligible Age

58 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marwa Aboelez, Phd

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Radwa Emera, Phd

Role: STUDY_DIRECTOR

Mansoura University

Locations

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Mansoura university

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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Emera RMK, Shady M, Alnajih MA. Comparison of retention and denture base adaptation between conventional and 3D-printed complete dentures. J Dent Res Dent Clin Dent Prospects. 2022 Summer;16(3):179-185. doi: 10.34172/joddd.2022.030. Epub 2022 Nov 15.

Reference Type BACKGROUND
PMID: 36704186 (View on PubMed)

Other Identifiers

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A10080921

Identifier Type: -

Identifier Source: org_study_id