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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implant
• Intervention / Treatment: Device: Immediate loading of early placed implants; Device: Conventional loading of early placed implants

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohammad A AL-Rababáh; Phone Number: 00962792131548; Email: malrababah@ju.edu.jo
• Study Contact Backup: Name: Dareen M Abu Mahfouz; Phone Number: 00962799435925; Email: dareen_abumahfouz@hotmail.com

Study Locations

• Jordan
  • Amman, Jordan
    • Recruiting
    • Jordan University Hospital
    • Contact: Mohammad A AL-Rababáh; Phone Number: 00962792131548; Email: malrababah@ju.edu.jo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 )	Device: 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.; Device: Conventional loading of early placed implants; Definitive loading of early placed implants upon successful osteointegration (after 8 weks)
Experimental: Immediate loading of early placed implants; 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; Implants with active thread design will be used. The implants placed will be randomly allocated into either immediate loading or conventional loading group.; Device: Conventional loading of early placed implants; Definitive loading of early placed implants upon successful osteointegration (after 8 weks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant failure rate	defined as implant removal	1 year
Implant stability	Osstell readings	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	as measured by periodontal probe	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	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.	after 6 months and 1 year of placements
Biological, estehtic and technical complications	(infection, implant mobility, or prosthesis-related issues) assessed by expert prosthodontist who is blind to the nature of intervention	1 year

Collaborators and Investigators

• Sponsor: University of Jordan
• Collaborators: Straumann Group; MegaGen

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 3, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Estimated): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: dental implant; immediate loading; conventional loading; thread design; early placement
• Other Study ID Numbers: 10/2024/22294

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No