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Prosthesis and Implant Survival in Immediately Loaded Temporary Full Arch Restorations

Prosthesis and Implant Survival in Immediately Loaded Full Arch Restorations Using Fiber Reinforced Versus Non-reinforced Temporary Frameworks: A Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03814070
Enrollment
114
Registered
2019-01-23
Start date
2019-02-28
Completion date
2020-03-31
Last updated
2019-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Completely Edentulous Patients

Brief summary

In immediate loading of implants of completely edentulous patients, the most common post-surgical complication following the surgery noted in the dental literature is fracture of the provisional restoration with rates ranging from 4.17% to 41%. Most of these fractures occur because polymethyl methacrylate (PMMA) materials are inadequate and have low rigidity to withstand extended periods of heavy occlusal use. Fractures of full arch provisional restorations during healing are concerning, because they eliminate cross-arch stabilization and disrupt stress distribution patterns which might jeopardize implant osseointegration affecting the survival rates for implants. Therefore, it is important to look for another material that has higher rigidity than PMMA and can withstand masticatory forces for extended periods without fractures or load concentration on the implants during the osseointegration period.

Interventions

PROCEDUREFiber-reinforced framework

Glass fiber- reinforced framework is to be picked up over the implant abutments to strengthen the full arch acrylic restorations

PROCEDURENo framework

Non-reinforced acrylic full arch prosthesis is to be picked up directly over the implant abutments.

Sponsors

Nermeen Ahmed Hassan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Completely edentulous patients. * Patients with proper amount of attached gingiva (≥2 mm)

Exclusion criteria

* Patients having a medical condition that absolutely contraindicates implant placement. * Patients with uncontrolled diabetes, assessed by measuring glycosylated hemoglobin (HbA1c). (greater than 6.4 percent) * Potentially uncooperative patients who are not willing to go through the proposed interventions. * Moderate-to-heavy daily smokers\* (who report consuming at least 11 cigarettes/day). * Patients with history of bruxism * If insertion torque for the implants is less than 35 Ncm

Design outcomes

Primary

MeasureTime frameDescription
Prosthesis survival4 monthsClinical evaluation of any fracture in the prosthesis

Secondary

MeasureTime frameDescription
Implant survival4 monthsClinical evaluation of implant loss
Peri-implant crestal bone loss during healing4 monthsCrestal bone loss around implants is to be measured using periapical x ray with parallel technique in millemeters

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026