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

NCT ID: NCT06693297

Last Updated: 2024-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-25

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Conventional loading of early placed implants

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

Group Type ACTIVE_COMPARATOR

Immediate loading of early placed implants

Intervention Type 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

Intervention Type DEVICE

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

Immediate loading of early placed implants

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

Group Type EXPERIMENTAL

Immediate loading of early placed implants

Intervention Type 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

Intervention Type DEVICE

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

Interventions

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Immediate loading of early placed implants

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

Intervention Type DEVICE

Conventional loading of early placed implants

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Straumann Group

UNKNOWN

Sponsor Role collaborator

MegaGen

UNKNOWN

Sponsor Role collaborator

University of Jordan

OTHER

Sponsor Role lead

Responsible Party

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Mohammad AL-Rababáh

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jordan University Hospital

Amman, , Jordan

Site Status RECRUITING

Countries

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Jordan

Central Contacts

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Mohammad A AL-Rababáh

Role: CONTACT

00962792131548

Dareen M Abu Mahfouz

Role: CONTACT

00962799435925

Facility Contacts

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Mohammad A AL-Rababáh

Role: primary

00962792131548

Other Identifiers

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10/2024/22294

Identifier Type: -

Identifier Source: org_study_id

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