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

NCT06693297 | Recruiting

• 1 other identifier: 10/2024/22294
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Implant

Keywords

dental implant; thread design; immediate loading; conventional loading; early placement

Outcome Measures

Primary Outcomes (1)

• Marginal bone level changes

  Marginal bone level changes by standardized periapical radiographs.

  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 (6)

• Implant failure rate

  1 year

• Implant stability

  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)

• Midfacial mucosal level

  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

• Pink and white esthetic scores

  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

• Patient Satisfaction

  after 6 months and 1 year of placements

Study Arms (2)

Conventional loading of early placed implants

ACTIVE COMPARATOR

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

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

Immediate loading of early placed implants

EXPERIMENTAL

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

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

Interventions

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; Immediate loading of early placed implants

Conventional loading of early placed implants DEVICE

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

Conventional loading of early placed implants; Immediate loading of early placed implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jordan: lead
• Straumann Group: collaborator
• MegaGen: collaborator

Study Sites (1)

Jordan University Hospital

Amman, Jordan

RECRUITING

Central Study Contacts

Mohammad A AL-Rababáh

CONTACT

00962792131548; malrababah@ju.edu.jo

Dareen M Abu Mahfouz

CONTACT

00962799435925; dareen_abumahfouz@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 18, 2024
• Study Start: September 25, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)