Immediate Loading Of Dental Implants: A Pilot Clinical Study

Université de Montréal

Status: Completed

Conditions: Dental Implantation

Treatments: Procedure: Immediate loading

Study type: Interventional

Funder types: Other

Identifiers

NCT01644058

UDEM-EE-2012b

Details and patient eligibility

About

Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular overdenture assisted by 2 immediately loaded unsplinted implants.

Full description

In this pre-post design, Phase-I clinical trial, 18 edentate individuals received a new set of complete denture. Then, following standard procedures, 3 threaded implants (OsseoSpeed TXTM, Dentsply Implants, Mölndal, Sweden) were placed in the mandible in each patient, and locator abutments (Zest Anchors LLC, Escondido, U.S.A.) were inserted on the right and left side implants. The midline implant served as a control for within-patient comparison. The immediate loading was conducted within 24 h of surgery. Data were collected at baseline (T0), 12 (T1) and 24 (T2) months after immediate loading. The clinical outcomes included implant survival rate, crestal bone level changes and implant stability. These criteria were assessed through clinical and radiographic examinations as well as resonance frequency analysis. Patient-centered outcomes included patient satisfaction and oral health-related quality of life measured using validated questionnaires. Brunner-Langer approach was used for statistical analysis.

Enrollment: 18 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Minimal age of 18 years
• Complete edentulism for more than 1 year
• Wear of total conventional prosthesis for more than 1 year
• Bone morphology in the anterior mandibular region amendable for the placement of 3 regular diameter implants without any additional procedure (graft or membrane).

Exclusion criteria

• Any absolute or relative contra-indication to implant therapy
• Physical incapacity to render oral or prosthetic hygiene
• Incapacity to obtain a free and informed consent
• Incapacity to assist to planned follow up appointments
• Incapacity to understand and complete questionnaires

Exclusion Criteria to Immediate Loading Protocol Found on One or Both of Un-splinted Implants During Surgery:

• Inadequate bone quality: IT<35 Ncm
• Inadequate primary stability: ISQ<60

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Immediate loading

Experimental group

Description:

Immediate loading of 2 endo-osseous mandibular implants

Treatment:

Procedure: Immediate loading