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

NCT06166446 | Completed

• 1 other identifier: A10080921
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periimplantitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

ACTIVE COMPARATOR

patients received lower denture fabricated by milling technique

Device: subtractive technique

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

ACTIVE COMPARATOR

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

Device: additive technique

Interventions

subtractive technique DEVICE

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

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

additive technique DEVICE

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

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

Eligibility Criteria

• Age: 58 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• poor denture adaptation co-operative patients

You may not qualify if:

• metabolic diseases uncontrolled diabetes osteoporosis and hyperparathyroidism.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

• 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.

  PMID: 36704186 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Subtractive Hybridization Techniques

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Gene Expression Profiling; Genetic Techniques; Investigative Techniques; Nucleic Acid Hybridization

Study Officials

• Marwa Aboelez, Phd

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Radwa Emera, Phd

  Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: December 3, 2023
• First Posted: December 12, 2023
• Study Start: January 15, 2022
• Primary Completion: April 25, 2022
• Study Completion: February 2, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)