Immediate Loading of Four Single Piece Compressive Implants for Bar Retained Mandibular Overdenture

NCT06514391 | Completed DMC

• 1 other identifier: A14030123
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

this study was done to evaluate clinically and radiographically four single piece inter-foraminal compressive implant connected via digitally designed co-cr milled bar with distal cantilever supporting mandibular overdenture. The evaluation will be done clinically and radiographically as following:

• Marginal bone loss
• Soft tissue changes around the implants

Conditions

Compressive Implants

Outcome Measures

Primary Outcomes (1)

• Peri-implant marginal bone loss

  Peri-implant marginal bone loss was evaluated for each implant by the aid of cone beam CT scan

  at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)

Secondary Outcomes (1)

• Peri-implant soft tissue health

  at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)

Study Arms (1)

compressive one piece implants with bar attachment

EXPERIMENTAL

All patients received 4 mandibular inter-foraminal single piece compressive implants, bar attachment connecting 4 implants was then cemented and complete mandibular overdenture was attached to bar via peek clips

Procedure: compressive single piece dental implant

Interventions

compressive single piece dental implant PROCEDURE

4 inter-foraminal single piece compressive dental implants were placed in the mandible via flapless protocol by the aid of stereolithographic surgical guide

compressive one piece implants with bar attachment

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They were healthy, free from any systemic diseases relating to the bone resorption such as uncontrolled diabetics or osteoprosis .This was achieved through medical history and clinical examination by physician.
• They have completely edentulous maxilla opposed by completely edentulous mandible
• All patients have sufficient inter-arch space for overdenture and milled bar construction not less than 12mm
• All patients are of Angel's class I maxillo-mandibular relationship.
• All patients must have mandibular bone height interforaminally not less than 8-10 mm as verified by cone beam C.T.

You may not qualify if:

• Patients with systemic issues such as recent myocardial infarction, hepatic patients, bleeding disorders, autoimmune diseases, hyperparathyroidism
• Uncontrolled diabetes mellitus
• Severe osteoporosis
• Cancer
• Recent organ transplants, long-term corticosteroid use
• Radiotherapy
• Uncooperative patients with psychiatric disorders
• Heavy smokers
• Poor oral hygiene
• Parafunctional habits

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Faculty of dentistry

Al Mansurah, Egypt

Location

Study Officials

• Mohamed Shady, MD

  Mansoura University Faculty of Dentistry, Prosthodontics department

  PRINCIPAL INVESTIGATOR

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: Assistant Professor

Model Details: all patients recieved 4 inter-foraminal compressive single piece dental implants in the mandible, then milled bar was digitally constructed and cemented to 4 implants to support mandibular implant overdenture

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: February 15, 2023
• Primary Completion: April 24, 2024
• Study Completion: June 13, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)