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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03748615
Other study ID # CairoUimplant master course
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 20, 2018
Est. completion date November 20, 2019

Study information

Verified date November 2018
Source Cairo University
Contact wallaa farahat mohamed, bds
Phone 01069543488
Email loulu_90_ooo@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The use of implants has significantly increased prosthetic options for edentulous patient. However, implant placement in the Posterior mandibular region is often hampered significantly by insufficient atrophic width limitations


Description:

Ridge splitting technique causes lateral ridge expansion which creates new implant bed by longitudinal osteotomy, positioning buccal cortex laterally. The buccal cortex is positioned laterally to create space between buccal and lingual cortical plates, which is filled by an endosseous implant with or without any graft material limitations.

Ridge split technique is a very predictable procedure that can achieve substantial gains in horizontal ridge width of the edentulous posterior mandible without associated morbidity. This technique allows the clinician to augment the site and do the implant insertion in a single stage surgery, shortening the healing period drastically.

In the conventional ridge splitting technique, a complete flap is raised to allow adequate visibility of the bone defect which can result in disturbance of vascular supply and increase bone resorption rates. In this case report, a new innovative computer guided closed alveolar ridge splitting flapless technique has been advocated to avoid this disruption.

As Guided implant placement showed a statistically superior accuracy when they are compared with freehand placement after guided osteotomy Computer guided ridge splitting may have a superior accuracy than the freehand ridge splitting and may reduce the time of surgery, healing period and post-operative pain.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date November 20, 2019
Est. primary completion date September 20, 2019
Accepts healthy volunteers No
Gender All
Age group 25 Years to 60 Years
Eligibility Inclusion Criteria:

- Patients with edentulous posterior area of the mandible insufficient width less than 5m, Both sexes.

- No intraoral soft and hard tissue pathology

- No systemic condition that contraindicate implant placement.

Exclusion Criteria:

- Heavy smokers more than 20 cigarettes per day.

- Patients with systemic disease that may affect normal healing.

- Psychiatric problems.

- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

- Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Computer Guided ridge splitting in posterior mandible
The computer guided ridge splitting for patients with atrophic posterior mandible and with residual bone width at least 3 to 5mm of residual ridge. The selected patients will be informed of the nature of the research work and informed consent will be signed. Radiographic examination included preoperative digital panoramic radiograph with 1:1 magnification for each patient as a primary survey to obtain an approximation of the available bone height and detect the presence of remaining roots and localized pathosis. Computer surgical guides are fabricated for partially edentulous patients using teeth and tissue as support for the guide. The same surgeon performed all surgeries. All surgical procedures were performed under strict aseptic conditions, all patients received nerve block local anesthesia (Articaine 4% 1:100 000 epinephrine). A crestal incision is made using No. 15 blade extending over the posterior mandible using computer guided surgical stent. no flap elevation .

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Time of the procedure ,pain and edema the time of the procedure will be measured numerical using visual analogue scan 4 month
See also
  Status Clinical Trial Phase
Completed NCT05307029 - Immediate and Flapless Full-arch Rehabilitation of Edentulous Jaws