Clinical trial NCT01644058: Immediate Loading Of Dental Implants: A Pilot Clinical Study
Official title: Immediate Loading Of Dental Implants In Mandible Full-Arch: A Pilot Clinical Study On Patients Satisfaction, Quality Of Life And Implant Success
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implantation
Keywords: immediate-loading
patient-based outcomes
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Satisfaction With the Immediate Loading Protocol
timeFrame: 4 months
measure: Oral-health-related Quality of Life With the Immediate Loading Protocol
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Université de Montréal
state: Quebec
Study officials:
affiliation: Université de Montréal, Faculty of Dentistry
name: Elham Emami, DDS, MSc,PhD
role: PRINCIPAL_INVESTIGATOR
References: