Clinical trial NCT06166446: Comparison of Denture Base Adaptation and Per-iimplant Tissue Health Between CAD and CAM Implant Overdenture
Official title: Comparison of Denture Base Adaptation and Per-implant Tissue Health Between CAD and CAM Implant Retained Complete Overdenture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periimplantitis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 15
Sex: ALL
Minimum age (years): 58
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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

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.

Eligibility criteria: Inclusion Criteria:

poor denture adaptation co-operative patients

Exclusion Criteria:

metabolic diseases uncontrolled diabetes osteoporosis and hyperparathyroidism.

Primary outcomes:
measure: Modified Plaque Index
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
Study officials:
affiliation: Mansoura University
name: Marwa Aboelez, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Radwa Emera, Phd
role: STUDY_DIRECTOR
References:
citation: 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.