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OpenTrials
Completed

NCT Number: NCT01949298

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental implant placement

Procedure

Primary outcomes

  1. Radiographic bone level change around the implants

    Time frame: 12 months

Secondary outcomes

  1. Implant survival

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • Dentsply Astra tech

Registry information

Official study title

Immediate vs Delayed Loading of Two Implants Supporting a Locator Retained Mandibular Overdenture - A Randomized Controlled Study

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 24, 2013
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.