Immediate vs Delayed Loading of Single Tooth Implants: Randomized Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Crestal bone loss
Study Overview
Brief Summary
Previous studies have shown high success rates of immediately loaded implants on par with conventionally loaded implants (DL), while a few studies have also reported failure rates. Various studies can be found in the English literature comparing IL to DL protocol, few of which used the flapless approach while few used cylindrical implants or were confined to maxillary anterior region. Furthermore, a perusal of literature revealed no study which used RVG for radiographic evaluation and evaluated the morbidity at the implant site in normal healthy adult population. Hence this study would help determine whether the IL protocol is on par with DL protocol, so as to reduce patient waiting time, prevent space closure and provide early patient satisfaction from an aesthetic stand point.
Detailed Description
Oral implants have become a reliable alternative to replace lost teeth as they have a very high survival rate. The survival rate of dental implants has improved significantly over the years and is often estimated to be above 90%. They support dental prosthesis, overdentures, crowns and bridges to restore oral function and aesthetics that the insertion of dental implants in bone has become one of the routine procedures in dental set up. It needs bone exposure which is associated with some amount of bone loss.
Osseointegrated implants are placed traditionally following a two stage protocol, wherein implants are left to heal unloaded for 3-4 months in mandible and 6-8 months in maxilla. Successful osseointegrated implants are anchored directly to bone. The presence of highly mineralized compact mature bone with many Haversian canals have been shown in the microscopy of retrieved implants from man and experimental animals. Regions of fibrous tissue interposition are not found. The newly formed bone has features of normality with marrow spaces filled with blood vessels.
However, in the presence of movement, a soft tissue interface may encapsulate the implant, causing its failure, that is, formation of a fibrous connective tissue rather than bone at the implant bone interface. A similar effect has been reported to occur in bone fractures that had been inadequately immobilized, resulting in a non-union of the fractured segments.
To minimize this, many clinicians advocate keeping the implants unloaded during the healing period. This traditional approach takes a longer treatment time and requires a second surgical intervention for connection of abutment to implant.
It would be beneficial to reduce the treatment period without affecting the success rate of the implants. Due to advancements in oral implantology, such as implant design and titanium surfaces treatment, the immediate loading concept has gained popularity by offering shortened treatment time, trauma reduction, decreased patient's anxiety, discomfort, improvement in function and esthetics. This treatment option also aims at maintenance of the hard and soft tissues and reducing the waiting period. Nowadays immediate and early loaded implants are becoming increasingly common due to the various benefits for patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •• Patient having minimum single tooth edentulous space.
- •Adequate bone quality and quantity at the implant site.
- •Patient with acceptable oral hygiene (Plaque index<1.5).
Exclusion Criteria
- •• Medically compromised patient or patient taking immunosuppressive drugs or bisphosphonates which may complicate the treatment outcome.
- •Infection at the implant site and adjacent site.
- •History of bruxism or parafunctional habits.
- •Patient having history of bleeding disorder or on anticoagulant therapy.
- •Chronic smoker and using tobacco in any form.
- •Patients allergic to medication (Local anesthetic, Penicillin group of antibiotics, non- steroidal anti-inflammatory drugs) and implant.
- •Pregnant or lactating females.
- •Individuals with unacceptable oral hygiene (PI>1.5).
- •History of radiotherapy in the head and neck area
Outcomes
Primary Outcomes
Crestal bone loss
Time Frame: 7 months primary, total time frame 4 years
Interproximal marginal bone loss
Secondary Outcomes
No secondary outcomes reported