Implant Survival Using Immediate Loading Protocol
Conditions
Keywords
immediate loading of dental implant, implant supported over denture
Brief summary
Edentulous patients have to wait after extractions and again after surgical implant placement for healing to occur before the implants can be restored and patients can go back to normal function. This delay in loading of implants can be handicapping for the patient, esthetically and functionally. Hence this project was undertaken with the purpose of reducing this wait period and achieving early rehabilitation in these patients. The aim of the project is to compare immediate loading versus delayed loading of implant supported mandibular dentures.
Interventions
PROCEDUREdental implant placement
Sponsors
Dentsply Astra tech
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Males and females at least \>=21y of age * Provision of informed consent * Totally edentulous arch requiring or wearing mandibular complete denture * Tooth in implant sites must have been extracted at least 4 months before the implant placement. * Adequate amount of bone support to insert a 8mm in length and 4mm in diameter implant without encroaching on vital structures. The amount of bone available should be such that after implant placement there should be minimum of 1mm lingual and buccal bone * Implant insertion torque \>=20Ncm * No need for bone augmentation procedures
Exclusion criteria
* Conditions or circumstances as evaluated by the investigator, which would prevent completion of study participation. * Conditions requiring chronic routine use of antibiotics or requiring prolonged use of steroids. * History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection * Use of investigational drugs or devices within 30 days of study period, * Alcoholism or drug abuse and heavy smokers \> 10 cigarettes a day. * Local factors such as * untreated periodontitis, * erosive lichen planus, * local irradiation history, * osseous lesion, * unhealed extraction socket, * intraoral infection, * lack of primary stability * inadequate oral hygiene * Simultaneous participation in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic bone level change around the implants | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Implant survival | 12 months |
Countries
United States
Outcome results
None listed