Immediate vs Delayed Loading of Two Implants Supporting a Mandibular Over Denture

UConn Health

Status: Completed

Conditions: Implant Survival Using Immediate Loading Protocol

Treatments: Procedure: dental implant placement

Study type: Interventional

Funder types: Other

Identifiers

NCT01949298

IE-10-305-3

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Immediate implant loading

Experimental group

Description:

The test group had implant immediately loaded by means of a implant supported mandibular denture connected with locator abutment.

Treatment:

Procedure: dental implant placement

Delayed implant loading group

Active Comparator group

Description:

The control group had implant loaded after 3 months of submerged healing by means of a implant supported mandibular denture connected with locator abutment.

Treatment:

Procedure: dental implant placement