Partially-guided Protocol for Maxillary Overdentures Retained by Ti-Zr One-piece Mini Implants

Launched by UNIVERSIDADE FEDERAL DE GOIAS · Oct 6, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new method for placing mini implants in the upper jaw (maxilla) to help secure dentures for people who no longer have their natural teeth. Participants in this study will receive six mini implants, which are small devices that act like tooth roots, to hold a type of denture called an overdenture more firmly in place. The goal is to see how accurately these implants can be placed using a partially-guided technique, which means the process is planned out in advance to ensure the best positioning and fit.

To join the trial, participants must be at least 60 years old and have a healed upper jaw that is ready for implants. They should currently be using a complete upper denture and have enough bone in their jaw to support the mini implants. Before joining, individuals will be screened for certain health conditions, such as uncontrolled diabetes or severe oral hygiene issues, as these may prevent them from participating. Throughout the study, participants can expect to have their oral health quality of life assessed and will be monitored for the success of the implants and any potential complications. This trial aims to improve the experience of wearing dentures for those in need.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥ 60 years of age
• • healed dentulous maxillary arch (minimum of twelve weeks since the last extraction)
• • wearing a complete maxillary denture evaluated as sufficient for surgical planning
• • minimal ridge dimensions of 5.4 mm (width) by 12 mm (height) in the anterior and premolar maxillary area
• • bone dimensions allowing the placement of one-piece implants with a 2.4 mm-diameter and minimum length of 10 mm.
• • general health condition should be a physical status ASA1 or ASA2.
• Exclusion Criteria:
• • inability to perform adequate oral hygiene
• • incapability to provide written informed consent and compliance to the protocol
• • any contraindication for oral surgery such as but not limited to,
• • uncontrolled diabetes
• • immunosuppression
• • radiation or chemotherapy
• • antiresorptive medication such as bisphosphonates
• • presence of dental, periodontal or peri-implant disease in the opposing arch
• • presence of a conventional complete denture in the opposing arch (mandible)
• • presence of an insufficient partial removable denture or implant-overdenture in the opposing arch, which cannot be rendered sufficient by a reline
• • heavy smoking habit with \> 20 cig/d
• • reported severe bruxism or clenching habits
• • clinically present oro-facial pain
• • depression with a Geriatric Depression Scale above 12
• • xerostomia with a stimulated salivary flow rate inferior to 0.7 ml/min
• • ridge morphology type IV (Cawood and Howell, 1988)
• • defects requiring bone augmentation procedures, or unhealthy soft tissues.