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

University of Jordan

Status: Enrolling

Conditions: Dental Implant

Treatments: Device: Immediate loading of early placed implants; Device: Conventional loading of early placed implants

Study type: Interventional

Funder types: Other

Identifiers

NCT06693297

10/2024/22294

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. aged 18 years or older
2. requiring single tooth replacement with dental implants in presence of four bone walls (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 study protocol and follow-up visits

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 bone metabolism
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Conventional loading of early placed implants

Active Comparator group

Description:

Early placed implants ( within 16 weeks of healing after Extraction of a tooth) will be conventionally loaded ( at least 8 weeks after implant placement )

Treatment:

Device: Conventional loading of early placed implants

Device: Immediate loading of early placed implants

Immediate loading of early placed implants

Experimental group

Description:

Early placed implants (within 16 weeks of tooth extraction) will be loaded immediately with provisional screw retained crown

Treatment:

Device: Conventional loading of early placed implants

Device: Immediate loading of early placed implants