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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01836744
Recruitment Status : Active, not recruiting
First Posted : April 22, 2013
Last Update Posted : July 5, 2019
Sponsor:
Collaborators:
Universidade do Porto
Dentsply Sirona Implants
Tecnoss OsteoBiol
Information provided by (Responsible Party):
Grupo de Investigação: Cirurgia Oral, Peridontologia, Implantologia

Brief Summary:
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 or disease Intervention/treatment Phase
Dental Implant Survival Rate Device: Survival rate dental implant (OsseoSpeed™) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: one sinus autologous bone graft other sinus - xenograft - osteobiol Mp3
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Seal envelops, codification of the side and patient and independent blind assessors
Primary Purpose: Treatment
Official Title: Survival Rate of Dental Implants Placed in Sinus Lift Performed With Two Different Grafts
Actual Study Start Date : March 18, 2013
Actual Primary Completion Date : June 20, 2017
Estimated Study Completion Date : March 30, 2023

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Histological and histomorphological analysis [ Time Frame: 6 mounths ]
    Histological and histomorphological analysis of the bone graft

  2. radiological analysis [ Time Frame: 6 mounths ]
    Comparation of the bone gain in a radiological analysis (initial and at 6 months)

  3. Clinical evaluation - questionary [ Time Frame: 6 mounths ]
    questionary about patient preference treatment

  4. Implant failure [ Time Frame: up to 5 years of loading ]
    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.

  5. Prosthesis failure [ Time Frame: up to 5 years of loading ]
    when prosthesis placement will not be possible due to implant failure or secondary to implant failure.

  6. Peri-implant marginal bone level changes [ Time Frame: up to 5 years ]

    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.


  7. Biological complications [ Time Frame: up to 5 years ]
    Biological complications (number and type). Particular attention will be used to assess possible sinus pathologies.

  8. Prosthetic complications [ Time Frame: up to 5 years ]
    Prosthetic complications (number and type).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836744


Locations
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Portugal
University of Porto, Faculty of Dental Medicine
Oporto, Porto, Portugal, 4200-256
Sponsors and Collaborators
Grupo de Investigação: Cirurgia Oral, Peridontologia, Implantologia
Universidade do Porto
Dentsply Sirona Implants
Tecnoss OsteoBiol
Investigators
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Principal Investigator: Francisco Correia, DDS, Msc, PhD Universidade do Porto
Study Director: Ricardo Faria Almeida, DDS, Msc, PhD Universidade do Porto
Study Chair: Antonio Campos Felino, DDS, PhD Universidade do Porto
Study Chair: Sonia Gouveia, Phd Instituto de Engenharia Eletrónica e Informática de Aveiro (IEETA/UA) and Centro de I&D em Matemática e Aplicações (CIDMA/UA), Universidade de Aveiro (UA), Portugal
Study Chair: Daniel H Pozza, DDS, PhD Departamento de Biomedicina da Faculdade de Medicina, and Faculdade de Ciências da Nutrição e Alimentação, and I3s, Universidade do Porto, Porto, Portugal.

Additional Information:
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Responsible Party: Grupo de Investigação: Cirurgia Oral, Peridontologia, Implantologia
ClinicalTrials.gov Identifier: NCT01836744    
Other Study ID Numbers: D-2012-024
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019