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Status unknownNCT03814070Updated Jan 23, 2019

Prosthesis and Implant Survival in Immediately Loaded Temporary Full Arch Restorations

An interventional study of Fiber-reinforced framework and No framework in Completely Edentulous Patients, sponsored by Nermeen Ahmed Hassan. Status unknown. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-23.

Sponsored by Nermeen Ahmed Hassan · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Completely Edentulous Patients

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03

In context

Mouth, Edentulous

244 studies on the registry are indexed under Mouth, Edentulous; 37 are open to participants now.

This study's planned enrollment of 114 is above the median of 30 across 187 interventional studies indexed under Mouth, Edentulous.

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Lead sponsor

This is the only study on the registry with Nermeen Ahmed Hassan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
114 participants (estimated)

Study arms

  • Active comparator
    Non-reinforced full arch acrylic restorations

    Procedure: No framework

  • Experimental
    full arch acrylic restorations with fiber-reinforced framework

    Procedure: Fiber-reinforced framework

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.

06

What researchers measure

Primary outcomes

  1. Prosthesis survival

    Clinical evaluation of any fracture in the prosthesis

    Time frame: 4 months

Secondary outcomes

  1. Implant survival

    Clinical evaluation of implant loss

    Time frame: 4 months

  2. Peri-implant crestal bone loss during healing

    Crestal bone loss around implants is to be measured using periapical x ray with parallel technique in millemeters

    Time frame: 4 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03814070
Lead sponsor
Nermeen Ahmed Hassan
Responsible party
Nermeen Ahmed Hassan (PhD candidate, Cairo University) — Sponsor-investigator
First posted
Jan 23, 2019
Start date
Feb 2019 (estimated)
Primary completion
Oct 2019 (estimated)
Completion
Mar 2020 (estimated)
Last update
Jan 23, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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