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

NCT ID: NCT01949298

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Implant Survival Using Immediate Loading Protocol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Immediate implant loading

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

Group Type EXPERIMENTAL

dental implant placement

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

dental implant placement

Intervention Type PROCEDURE

Interventions

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dental implant placement

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dentsply Astra tech

UNKNOWN

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role lead

Responsible Party

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Gian Schincaglia

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17716257 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27004292 (View on PubMed)

Other Identifiers

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IE-10-305-3

Identifier Type: -

Identifier Source: org_study_id