NCT06599450

Single vs. Two Implants for Mandibular Overdentures

Clinical and Radiographic Comparison of Symphyseal and Parasymphyseal Single Implant Versus Two Implants in Complete Mandibular Overdentures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: Male
• Age: 50 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to compare the use of single implants in the symphyseal and parasymphyseal, and two implants were inserted in the canine area bilaterally to assist mandibular complete overdentures regarding clinical evaluation, marginal bone loss, and masticatory efficiency. The null hypothesis was that there was no statistically significant difference in clinical evaluation, marginal bone loss, and masticatory efficiency among single symphyseal implants, single parasymphyseal implants, and two-implant-assisted complete mandibular overdentures.

Detailed description

This randomized, controlled clinical trial compared the symphyseal and parasymphyseal single implants versus two implants in complete mandibular overdentures. Fifteen completely edentulous male patients (50-65 years) were chosen and randomly grouped into three equal groups (five patients in each) according to the position and number of the received implants to assist mandibular complete overdentures. Group I: single median implant. Group II: single parasymphyseal implant. Group III: two implants were inserted in the canine area bilaterally. After three months of osseointegration, the lower denture was transformed into an implant-assisted complete mandibular overdenture. Clinical observations were documented on the day of loading, three, six, and nine months later for each implant. Follow-up CBCT scans were performed to assess marginal bone loss on the day of loading, six and twelve months later. The masticatory efficiency evaluation was conducted one month and three months after loading.

Conditions

• Bleeding on Probing
• Alveolar Bone Loss
• Mastication
• Dental Plaque
• Periodontal Index

Interventions

Type	Name	Description
DEVICE	Root form dental implant	Placement of titanium endosteal root form threaded tapered two-piece dental implant to assist mandibular complete overdenture

Timeline

• Start date: 2021-10-01
• Primary completion: 2023-11-01
• Completion: 2024-01-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Egypt