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

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ClinicalTrials.gov Identifier: NCT01949298
Recruitment Status : Completed
First Posted : September 24, 2013
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Dentsply Astra tech
Information provided by (Responsible Party):
Gian Schincaglia, 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.

Condition or disease Intervention/treatment Phase
Implant Survival Using Immediate Loading Protocol Procedure: dental implant placement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immediate vs Delayed Loading of Two Implants Supporting a Locator Retained Mandibular Overdenture - A Randomized Controlled Study
Study Start Date : July 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Experimental: Immediate implant loading
The test group had implant immediately loaded by means of a implant supported mandibular denture connected with locator abutment.
Procedure: dental implant placement
Active Comparator: Delayed implant loading group
The control group had implant loaded after 3 months of submerged healing by means of a implant supported mandibular denture connected with locator abutment.
Procedure: dental implant placement



Primary Outcome Measures :
  1. Radiographic bone level change around the implants [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Implant survival [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01949298


Locations
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United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Dentsply Astra tech
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gian Schincaglia, Clinical Associate Professor, UConn Health
ClinicalTrials.gov Identifier: NCT01949298    
Other Study ID Numbers: IE-10-305-3
First Posted: September 24, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by Gian Schincaglia, UConn Health:
immediate loading of dental implant
implant supported over denture