NCT01949298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

3.5 years

First QC Date

September 19, 2013

Last Update Submit

December 1, 2014

Conditions

Implant Survival Using Immediate Loading Protocol

Keywords

immediate loading of dental implantimplant supported over denture

Outcome Measures

Primary Outcomes (1)

  • Radiographic bone level change around the implants

    12 months

Secondary Outcomes (1)

  • Implant survival

    12 months

Study Arms (2)

Immediate implant loading

EXPERIMENTAL

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

Procedure: dental implant placement

Delayed implant loading group

ACTIVE COMPARATOR

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

Interventions

dental implant placementPROCEDURE
Delayed implant loading groupImmediate implant loading

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related Publications (2)

  • 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.

    PMID: 17716257BACKGROUND

  • 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.

    PMID: 27004292DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

September 19, 2013

First Posted

September 24, 2013

Study Start

July 1, 2010

Primary Completion

January 1, 2014

Study Completion

November 1, 2014

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

US(1)