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Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns

ConditionDental Implant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Jordan

About this trial

This study focuses on examining the efficacy and clinical performance of immediate loading of early placed single implants.

The aim of the randomized controlled trial is to compare between two loading protocols (immediate versus conventional) of early placed implants (Type 2-3A) in terms of clinical, radiographic, and patient-reported outcomes.

Null hypothesis: There will be no significant differences in implant survival/success, stability, radiographic marginal bone level, and patient reported outcomes between immediately or conventionally loaded and early placed implants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

aged 18 years or older

requiring single tooth replacement with dental implants in presence of four bone walls (mandible or maxilla)

having adequate bone volume

controlled oral hygiene

Disqualifiers

Any systemic condition that might jeopardize implant surgery

history of radiation therapy to the head and neck region

history of bisphosphonate therapy or other medications that may affect bone metabolism

smoking more than 10 cigarettes/day

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immediate loading of early placed implants

    Device

    Implants with active thread design will be used. The implants placed will be randomly allocated into either immediate loading or conventional loading group.

  • Conventional loading of early placed implants

    Device

    Definitive loading of early placed implants upon successful osteointegration (after 8 weks)

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Conventional loading of early placed implantsActive comparator 2 interventions
Group B: Immediate loading of early placed implantsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Marginal bone level changes

Marginal bone level changes by standardized periapical radiographs.

Time frame
Baseline (day of implant placement), at definitive loading (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group), and at 1-year follow-up post-loading.

Secondary outcomes

1

Implant failure rate

defined as implant removal

Time frame
1 year
2

Implant stability

Osstell readings

Time frame
Baseline (day of implant placement), at definitive loading (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group)
3

Midfacial mucosal level

as measured by periodontal probe

Time frame
at time of delivery of definitive prosthesis (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group) and one-year follow-up
4

Pink and white esthetic scores

Time frame
at time of delivery of definitive prosthesis (more than 8 weeks post-placement for the conventional loading group, within 1 week post-placement for the immediate loading group) and one-year follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Jordan

Lead sponsor

Straumann Group

Collaborator

MegaGen

Collaborator

Source ClinicalTrials.gov
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