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

Comparison of Denture Base Adaptation and Per-implant Tissue Health Between CAD and CAM Implant Retained Complete Overdenture

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

Study Overview

• Status: Completed
• Conditions: Periimplantitis
• Intervention / Treatment: Device: subtractive technique; Device: additive technique

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

poor denture adaptation co-operative patients

Exclusion Criteria:

metabolic diseases uncontrolled diabetes osteoporosis and hyperparathyroidism.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: a CAD/CAM-milled mandibular overdenture and a maxillary acrylic conventional complete denture; patients received lower denture fabricated by milling technique	Device: subtractive technique; The milled denture teeth are then bonded into the milled recesses using a special PMMA bonding system.
Active Comparator: 3rd printed mandibular overdenture and a maxillary acrylic conventional complete denture; The denture base was fabricated by adding the material layer by layer	Device: additive technique; The denture teeth were printed as one unit using the same method with tooth resin (DENTCA Denture Tooth, Shade A2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Plaque Index	a calibrated pressure sensitive plastic periodontal probe, the distance between marginal border of the peri-implant mucosa and the tip of the probe was measured and considered as pocket depth	12 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Marwa Aboelez, Phd, Mansoura University; Study Director: Radwa Emera, Phd, Mansoura University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): April 25, 2022
• Study Completion (Actual): February 2, 2023

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: December 3, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: A10080921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No