Clinical trial NCT06693297: Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns
Official title: Immediate Versus Conventional Loading of Early Placed Dental Implant Supporting Single Crowns: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Implant
Keywords: dental implant
thread design
immediate loading
conventional loading
early placement
Lead sponsor: University of Jordan
Sponsor class: OTHER
Collaborators: name: Straumann Group
name: MegaGen
First posted: 2024-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Marginal bone level changes
timeFrame: 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:
measure: Implant failure rate
timeFrame: 1 year
measure: Implant stability
timeFrame: 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)
measure: Midfacial mucosal level
timeFrame: 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
measure: Pink and white esthetic scores
timeFrame: 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
measure: Patient Satisfaction
timeFrame: after 6 months and 1 year of placements
measure: Biological, estehtic and technical complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
References: