NCT06628492

Brief Summary

implant will be inserted in patients with kennedy class 3 or 4 partially edentulous mandible .the implants will be inserted using teeth supported surgical guide fabricated from two different materials

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

October 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

October 1, 2024

Last Update Submit

October 3, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • linear deviation of inserted implant

    coronal and apical deviation of inserted implant from virtually planned one in millimeter.

    1 month

  • angular deviation of inserted implant

    angular deviation of inserted implant from virtually planned one in angles.

    1 month

Study Arms (2)

group A implant inserted by stainless steel surgical guide

EXPERIMENTAL
Device: stainless steel printed surgical guide

group B implant inserted by resin surgical guide

ACTIVE COMPARATOR
Device: resin printed surgical guide

Interventions

the patient will wear the stainless steel surgical guide for the insertion of one implant

group A implant inserted by stainless steel surgical guide

the patient will wear the resin surgical guide for insertion of adjacent another implant implant

group B implant inserted by resin surgical guide

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with skeletal Angle´s class I maxilla-mandibular relationship,
  • adequate inter-arch distance, have Kennedy class 3 or 4 partially edentulous mandible of more than 2 teeth missed and will be applied for the treatment of tooth loss and requiring fixed prosthodontic rehabilitation
  • normal Physical and psychological status to tolerate conventional implant procedures,
  • Their residual ridge had sufficient bone volume for implant installation and was covered by firm mucoperiosteum.

You may not qualify if:

  • Smokers.
  • Patients undergoing chemotherapy or radiotherapy and immunocompromised patients.
  • Patients with, systemic disease that might complicate post-operative healing or contribute to bone resorption, e.g uncontrolled diabetes, psychological disorders, or alcohol, tobacco, or drug abuse
  • parafunctional habits, poor oral hygiene, limited mouth opening, severe alveolar bone deficiencies,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 8, 2024

Study Start

October 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

October 8, 2024

Record last verified: 2024-10