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

Not Applicable

Completed

• Conditions: Implant Survival Using Immediate Loading Protocol
• Interventions: Procedure: dental implant placement

• Registration Number: NCT01949298
• Lead Sponsor: UConn Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-09-23
• Study First Posted: 2013-09-24
• Primary Completion: 2014-01
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate implant loading	dental implant placement	The test group had implant immediately loaded by means of a implant supported mandibular denture connected with locator abutment.
Delayed implant loading group	dental implant placement	The control group had implant loaded after 3 months of submerged healing by means of a implant supported mandibular denture connected with locator abutment.

Primary Outcome Measures

Name	Time	Method
Radiographic bone level change around the implants	12 months

Secondary Outcome Measures

Name	Time	Method
Implant survival	12 months

Trial Locations

Locations (1)

University of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States