Clinical Trials Directory

Trials / Completed

CompletedNCT06514391

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

Immediate Loading of Four Single Piece Compressive Implants for Bar Retained Mandibular Overdenture: A Study of Peri Implant Soft Tissue Health and Marginal Bone Loss

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Mansoura University · Academic / Other
Sex
All
Age
50 Years – 70 Years
Healthy volunteers
Accepted

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

Detailed description

Six patients of age ranging from 40 to 60years (mean 50 years) were selected for this study from the out patients clinic, Prosthodontics department, Faculty of Dentistry, Mansoura University. I) Preparation of the patient for implant placement: 1. A cone beam C.T was done for each patient to determine the bone height and the adequate sites for the placement of four interforaminal implants. 2. Mandibular denture was constructed to aid in designing of surgical stent to guide in implant placement. II) Surgical phase : 1. Surgical stent was used to guide in implant placement. All implants were placed according to the flapless protocol under local anesthesia. 2. All patients received four dental implants located anterior to the mental foramen in canine and premolar position. III) Prosthetic phase: 1. The necks of the placed implants were bent up to 15 degree to ensure parallelism. 2. Intraoral final impression was done by intraoral scanner to be used for digital designing of the milled bar and the final prosthesis. 3. bar design was milled in PMMA resin material and tried over implants, then resin bar try-in was invested and casted in co-cr alloy. 4. Final bar was inserted intra-orally after finishing and polishing 5. The four implant bar assembly was then loaded by the prefabricated acrylic denture according to Browaeys H et al , 2014. Access holes were made above the abutment to be finally relined in the patient mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol. 6. The occlusion was adjusted and the patients were instructed to go on soft diet for the first 48 hours until final impressions and delivery of milled bar overdenture were done. IV) Evaluation: Probing depth was measured for each implant using plastic probe and radiographic evaluation of the peri-implant marginal bone loss by using cone beam CT started for the patients from the delivery of final prosthesis (T0) and continue for 6 months (T6) and 12 month (T12) from insertion.

Conditions

Interventions

TypeNameDescription
PROCEDUREcompressive single piece dental implant4 inter-foraminal single piece compressive dental implants were placed in the mandible via flapless protocol by the aid of stereolithographic surgical guide

Timeline

Start date
2023-02-15
Primary completion
2024-04-24
Completion
2024-06-13
First posted
2024-07-23
Last updated
2024-07-23

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06514391. Inclusion in this directory is not an endorsement.