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

Periimplantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06166446
• Other study ID #: A10080921
• Status: Completed
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: February 2, 2023

Study information

• Verified date: November 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2, 2023
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 58 Years to 68 Years

Eligibility

Inclusion Criteria:

poor denture adaptation co-operative patients

Exclusion Criteria:

metabolic diseases uncontrolled diabetes osteoporosis and hyperparathyroidism.

Related Conditions & MeSH terms

• Peri-Implantitis
• Periimplantitis

Intervention

Device:
• subtractive technique
The milled denture teeth are then bonded into the milled recesses using a special PMMA bonding system.
• additive technique
The denture teeth were printed as one unit using the same method with tooth resin (DENTCA Denture Tooth, Shade A2).

Locations

Country	Name	City	State
Egypt	Mansoura university	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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