NCT06204692

Brief Summary

This study's goal is to evaluate the efficacy of traditional rehabilitation with freehand implant implantation of partly or totally edentulous patients utilizing flapless or mini-flap procedures vs. 3D implant design software and specialized surgical templates.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

December 26, 2023

Last Update Submit

January 10, 2024

Conditions

Dental Implant

Keywords

virtual planning;computer guided implants;freehand implant;dental implant

Outcome Measures

Primary Outcomes (1)

  • marginal bone loss

    Cone Beam Computed Tomography

    6 months postoperative

Secondary Outcomes (1)

  • post-surgical pain and swelling

    7 days prior to implant placement

Study Arms (1)

Computer Guided Dental Implant Surgery.

OTHER

Computer Guided Dental Implant Surgery

Procedure: dental implant

Interventions

dental implantPROCEDURE

consisted of 6 patients where computer guided dental implant placement

Computer Guided Dental Implant Surgery.

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • totally edentulous in one or both arches,
  • with at least 7 mm of height and 4 mm of breadth in their bones as assessed by preoperative CBCT scans.
  • patients between the ages of 35 and 65 who could give informed permission,
  • Implants next to each other required to be positioned at least 3 mm apart from each other and 1.5 mm apart from the tooth.

You may not qualify if:

  • Patients who have received radiation therapy to the head and neck region within the year prior to implantation,
  • those who are receiving intravenous amino bisphosphonates,
  • those who have untreated periodontitis,
  • those with uncontrolled diabetes,
  • pregnant women, or nursing mothers are among the general contraindications to implant surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

nermine Ramadan Mahmoud

Cairo, 12566, Egypt

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor, faculty of Dentistry, October 6 University

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 12, 2024

Study Start

June 1, 2022

Primary Completion

June 30, 2023

Study Completion

September 28, 2023

Last Updated

January 12, 2024

Record last verified: 2024-01

Locations

EG(1)