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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Peri-implant marginal bone loss
Study Overview
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
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:
- 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.
- Mandibular denture was constructed to aid in designing of surgical stent to guide in implant placement.
II) Surgical phase :
- Surgical stent was used to guide in implant placement. All implants were placed according to the flapless protocol under local anesthesia.
- All patients received four dental implants located anterior to the mental foramen in canine and premolar position.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •Patients with systemic issues such as recent myocardial infarction, hepatic patients, bleeding disorders, autoimmune diseases, hyperparathyroidism
- •Uncontrolled diabetes mellitus
- •Severe osteoporosis
- •Recent organ transplants, long-term corticosteroid use
- •Radiotherapy
- •Uncooperative patients with psychiatric disorders
- •Heavy smokers
- •Poor oral hygiene
- •Parafunctional habits
Arms & Interventions
compressive one piece implants with bar attachment
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
Intervention: compressive single piece dental implant (Procedure)
Outcomes
Primary Outcomes
Peri-implant marginal bone loss
Time Frame: at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)
Peri-implant marginal bone loss was evaluated for each implant by the aid of cone beam CT scan
Secondary Outcomes
- 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))
Investigators
Mohamed shady
Assistant Professor
Mansoura University