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Prosthesis and Implant Survival in Immediately Loaded Temporary Full Arch Restorations

N

Nermeen Ahmed Hassan

Status

Unknown

Conditions

Completely Edentulous Patients

Treatments

Procedure: Fiber-reinforced framework
Procedure: No framework

Study type

Interventional

Funder types

Other

Identifiers

NCT03814070
Nermeen Ahmed Hassan

Details and patient eligibility

About

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.

Enrollment

114 estimated patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

114 participants in 2 patient groups

Non-reinforced full arch acrylic restorations
Active Comparator group
Treatment:
Procedure: No framework
full arch acrylic restorations with fiber-reinforced framework
Experimental group
Treatment:
Procedure: Fiber-reinforced framework

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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