Dental Implant
Conditions
Keywords
dental implant, thread design, immediate loading, conventional loading, early placement
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.
Interventions
DEVICEImmediate 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.
DEVICEConventional loading of early placed implants
Definitive loading of early placed implants upon successful osteointegration (after 8 weks)
Sponsors
Straumann Group
MegaGen
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal bone level changes | 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. | Marginal bone level changes by standardized periapical radiographs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Osstell readings |
| 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 | as measured by periodontal probe |
| Implant failure rate | 1 year | defined as implant removal |
| Patient Satisfaction | after 6 months and 1 year of placements | 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. |
| Biological, estehtic and technical complications | 1 year | (infection, implant mobility, or prosthesis-related issues) assessed by expert prosthodontist who is blind to the nature of intervention |
| 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 | — |
Countries
Jordan
Contacts
Primary ContactMohammad A AL-Rababáh
Backup ContactDareen M Abu Mahfouz
Outcome results
None listed