Survival Rate of Dental Implants Placed in Sinus Lift Performed With Two Different Grafts

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Grupo de Investigação: Cirurgia Oral, Peridontologia, Implantologia
Sponsor:
Collaborators:
University of Porto Faculty of Dental Medicine
Dentsply Implants
Information provided by (Responsible Party):
Grupo de Investigação: Cirurgia Oral, Peridontologia, Implantologia
ClinicalTrials.gov Identifier:
NCT01836744
First received: March 11, 2013
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

Previous in a randomized way, it will be performance 12 bilateral sinus lift with autologous bone in one side and the in other with xenograft material. After 6 mouths we will place 1 to 3 implants in each side and analyse the survival rate and possibles differences related to; prosthesis failure; biological and prosthetic complications; peri-implant marginal bone level changes.


Condition Intervention Phase
Dental Implant Survival Rate
Device: Survival rate dental implant (OsseoSpeed™)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Survival Rate of Dental Implants Placed in Sinus Lift Performed With Two Different Grafts

Further study details as provided by Grupo de Investigação: Cirurgia Oral, Peridontologia, Implantologia:

Primary Outcome Measures:
  • Implant failure [ Time Frame: up to 5 years of loading ] [ Designated as safety issue: No ]
    implant mobility assessed manually with the removed prosthesis and/or any infection dictating implant removal. Assessments will be done at delivery of the provisional and definitive prostheses, 1, 3 and 5 years of loading by tightening the abutment screws with the removed prostheses.

  • Prosthesis failure [ Time Frame: 6 mounths ] [ Designated as safety issue: No ]
    when prosthesis placement will not be possible due to implant failure or secondary to implant failure.

  • Biological and prosthetic complications [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
    Biological and prosthetic complications (number and type). Particular attention will be used to assess possible sinus pathologies.

  • Peri-implant marginal bone level changes [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

    Peri-implant marginal bone level changes assessed on periapical radiographs taken with the paralleling technique at implant placement, at initial prosthetic loading, 1 and 5 years follow-up in function.

    The distance between marginal bone level and implant/abutment junction, approximated to half mm, will be measured at both mesial and distal sides and averaged. Bone level changes at single implants will be averaged at patients level and then at group level.



Estimated Enrollment: 12
Study Start Date: March 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: survival rate autologous bone
dental implant placement in the previous sinus lift side with autologous bone; dental implant placement in the previous sinus lift side with xenograft material side;
Device: Survival rate dental implant (OsseoSpeed™)
Other Name: OsseoSpeed™ dental implant
Active Comparator: survival rate axenograft material
dental implant placement in the previous sinus lift side with xenograft material side;
Device: Survival rate dental implant (OsseoSpeed™)
Other Name: OsseoSpeed™ dental implant

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any partially edentulous patient having bilateral edentulism in the posterior maxillae (premolars and/or molars) with a similar degree of bone resorption requiring one to three implants at each side, being 18 years or older, and able to sign an informed consent. For all the potentially included patients preoperative CBCT (cone beam computed tomography) or CT scans and OPGs (orthopantomograph)must be obtained and attached to the files. The vertical bone height below the maxillary sinus at the implant sites must be of 1-5 mm and bone thickness at least 6 mm measured on CBCT (cone-beam computed tomography)or CT scans. Smokers will be included and patients will be grouped into: 1) non smokers; 2) light smokers ≤ 10 cigarettes/day; 3) heavy smokers ≥ 11 cigarettes/day, according to what they declare.

Exclusion Criteria:

  • General contraindications to implant surgery.
  • Patients irradiated in the head and neck area.
  • Immunosuppressed or immunocompromised patients.
  • Patients treated or under treatment with intravenous amino-bisphosphonates.
  • Patients with untreated periodontitis.
  • Patients with poor oral hygiene and motivation.
  • Uncontrolled diabetes.
  • Pregnancy or nursing.
  • Substance abuser.
  • Psychiatric problems or unrealistic expectations.
  • Lack of opposite occluding dentition in the area intended for implant placement.
  • Patients with an acute or chronic sinusitis.
  • Patients participating in other trials, if the present protocol cannot be properly adhered too.
  • Patients referred only for implant placement.
  • Patient unable to be followed for 5 years after loading.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836744

Contacts
Contact: Francisco Correia + 351 916113727 franciscodcorreia@gmail.com

Locations
Portugal
University of Porto, Faculty of Dental Medicine Recruiting
Oporto, Porto, Portugal, 4200-256
Contact: Francisco Correia    +351 91 611 37 27    franciscodcorreia@gmail.com   
Principal Investigator: Francisco Correia         
Principal Investigator: Ricardo Faria Almeida         
Principal Investigator: Sonia Gouveia         
Principal Investigator: Antonio Campos Felino         
Sponsors and Collaborators
Grupo de Investigação: Cirurgia Oral, Peridontologia, Implantologia
University of Porto Faculty of Dental Medicine
Dentsply Implants
Investigators
Principal Investigator: Francisco Correia University of Porto Faculty of Dental Medicine
Study Director: Ricardo Faria Almeida University of Porto Faculty of Dental Medicine
Study Chair: Antonio Campos Felino University of Porto Faculty of Dental Medicine
Study Chair: Sonia Gouveia University of Porto Faculty of Dental Medicine
Study Chair: Daniel H Pozza, DDS, PhD Department of Experimental Biology Centre of Medical Research-Faculty of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Grupo de Investigação: Cirurgia Oral, Peridontologia, Implantologia
ClinicalTrials.gov Identifier: NCT01836744     History of Changes
Other Study ID Numbers: D-2012-024
Study First Received: March 11, 2013
Last Updated: April 23, 2013
Health Authority: Portugal: Health Ethic Committee

ClinicalTrials.gov processed this record on September 16, 2014