Clinical trial NCT01949298: Immediate vs Delayed Loading of Two Implants Supporting a Mandibular Over Denture
Official title: Immediate vs Delayed Loading of Two Implants Supporting a Locator Retained Mandibular Overdenture - A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Survival Using Immediate Loading Protocol
Keywords: immediate loading of dental implant
implant supported over denture
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Dentsply Astra tech
First posted: 2013-09-24
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Radiographic bone level change around the implants
timeFrame: 12 months
Secondary outcomes:
measure: Implant survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
References:
citation: Marzola R, Scotti R, Fazi G, Schincaglia GP. Immediate loading of two implants supporting a ball attachment-retained mandibular overdenture: a prospective clinical study. Clin Implant Dent Relat Res. 2007 Sep;9(3):136-43. doi: 10.1111/j.1708-8208.2007.00051.x.
citation: Schincaglia GP, Rubin S, Thacker S, Dhingra A, Trombelli L, Ioannidou E. Marginal Bone Response Around Immediate- and Delayed-Loading Implants Supporting a Locator-Retained Mandibular Overdenture: A Randomized Controlled Study. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):448-58. doi: 10.11607/jomi.4118.