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Completed

NCT Number: NCT06166446

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

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Key information

Age range

58 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university

Al Mansurah, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

poor denture adaptation co-operative patients

Exclusion criteria

metabolic diseases uncontrolled diabetes osteoporosis and hyperparathyroidism.

Treatment and study plan

subtractive technique

Device

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

additive technique

Device

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

Primary outcomes

  1. Modified Plaque Index

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 12, 2023
Registry last updated
Dec 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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