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NCT Number: NCT06693297

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

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.

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Key information

Conditions

Dental Implant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • having agreed to take part in the study and willing to comply with the study protocol and follow-up visits

Exclusion criteria

  • 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
  • history of bruxism or parafunctional habits
  • localized/generalized periodontitis
  • patients in need of bone grafting
  • any known allergy or hypersensitivity to implant materials

Treatment and study plan

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)

Primary outcomes

  1. Marginal bone level changes

    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.

    Marginal bone level changes by standardized periapical radiographs.

Secondary outcomes

  1. Implant failure rate

    Time frame: 1 year

    defined as implant removal

  2. Implant stability

    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)

    Osstell readings

  3. Midfacial mucosal level

    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

    as measured by periodontal probe

  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

  5. Patient Satisfaction

    Time frame: after 6 months and 1 year of placements

    To be assesses by oral health impact profile-14 (OHIP-14), The scale includes 14 items covering various aspects of oral health-related quality of life, Score Range: from 0 to 56, Higher OHIP-14 scores indicate a worse outcome, representing a greater negative impact of oral health issues on quality of life, while lower scores suggest a better outcome or less impact on the individual's daily life.

  6. Biological, estehtic and technical complications

    Time frame: 1 year

    (infection, implant mobility, or prosthesis-related issues) assessed by expert prosthodontist who is blind to the nature of intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Dareen M Abu Mahfouz

CONTACT

[email protected]

00962799435925

Mohammad A AL-Rababáh

CONTACT

[email protected]

00962792131548

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Collaborators

  • MegaGen
  • Straumann Group

Registry information

Official study title

Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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