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

Last updated: November 14, 2024
Sponsor: University of Jordan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dental Filling

Treatment

Conventional loading of early placed implants

Immediate loading of early placed implants

Clinical Study ID

NCT06693297
10/2024/22294
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Inclusion

Inclusion Criteria:

  1. aged 18 years or older

  2. requiring single tooth replacement with dental implants in presence of four bonewalls (mandible or maxilla)

  3. having adequate bone volume

  4. controlled oral hygiene

  5. having agreed to take part in the study and willing to comply with the studyprotocol and follow-up visits

Exclusion

Exclusion Criteria:

  1. Any systemic condition that might jeopardize implant surgery

  2. history of radiation therapy to the head and neck region

  3. history of bisphosphonate therapy or other medications that may affect bonemetabolism

  4. smoking more than 10 cigarettes/day

  5. history of bruxism or parafunctional habits

  6. localized/generalized periodontitis

  7. patients in need of bone grafting

  8. any known allergy or hypersensitivity to implant materials

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Conventional loading of early placed implants
Phase:
Study Start date:
September 25, 2024
Estimated Completion Date:
September 30, 2026

Study Description

Study design:

This study is designed as a parallel group randomized controlled trial with an allocation ratio of 1:1.

The (PICO) study design: population will be patients from Jordan University Hospital aged 18 years or older, requiring single tooth replacement (molar or premolar) with dental implants, with sufficient bone volume and controlled oral hygiene. The intervention group will receive immediate loading of early placed implants (within 1 week), while the comparator group will receive conventional loading (after more than 8 weeks). The primary outcome is changes in marginal bone levels, and the secondary outcomes include implant primary osseointegration, stability, patient satisfaction, and various complications.

Both groups will receive early placed implants after 8-12 weeks of healing (Type 2-3A placement). The surgical procedure will follow standardized protocols, with no variations between groups other than the loading time.

Blinded assessors will perform radiographic and clinical evaluations at designated follow-up visits: at implant placement, definitive loading, 6 months, and 1 year. Ethical approval is obtained prior to study commencement, and all participants will provide informed consent.

Connect with a study center

  • Jordan University Hospital

    Amman,
    Jordan

    Active - Recruiting

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