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

NCT01836744 | Completed Phase 4 DMC

• 1 other identifier: D-2012-024
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant Survival Rate

Outcome Measures

Primary Outcomes (8)

• Histological and histomorphological analysis

  Histological and histomorphological analysis of the bone graft

  6 mounths

• radiological analysis

  Comparation of the bone gain in a radiological analysis (initial and at 6 months)

  6 mounths

• Clinical evaluation - questionary

  questionary about patient preference treatment

  6 mounths

• Implant failure

  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.

  up to 5 years of loading

• Prosthesis failure

  when prosthesis placement will not be possible due to implant failure or secondary to implant failure.

  up to 5 years of loading

• Peri-implant marginal bone level changes

  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.

  up to 5 years

• Biological complications

  Biological complications (number and type). Particular attention will be used to assess possible sinus pathologies.

  up to 5 years

• Prosthetic complications

  Prosthetic complications (number and type).

  up to 5 years

Study Arms (2)

survival rate autologous bone

ACTIVE COMPARATOR

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™)

survival rate axenograft material

ACTIVE COMPARATOR

dental implant placement in the previous sinus lift side with xenograft material side;

Device: Survival rate dental implant (OsseoSpeed™)

Interventions

Survival rate dental implant (OsseoSpeed™) DEVICE

Also known as: OsseoSpeed™ dental implant

survival rate autologous bone; survival rate axenograft material

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grupo de Investigação: Cirurgia Oral, Peridontologia, Implantologia: lead
• Universidade do Porto: collaborator
• Dentsply Sirona Implants and Consumables: collaborator
• Tecnoss OsteoBiol: collaborator

Study Sites (1)

University of Porto, Faculty of Dental Medicine

Porto, Porto District, 4200-256, Portugal

Location

Related Links

• Related Info

Study Officials

• Francisco Correia, DDS, Msc, PhD

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

• Ricardo Faria Almeida, DDS, Msc, PhD

  Universidade do Porto

  STUDY DIRECTOR

• 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.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Seal envelops, codification of the side and patient and independent blind assessors
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomizes split month trial: * one sinus autologous bone graft * other sinus - xenograft - osteobiol Mp3

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: April 22, 2013
• Study Start: March 18, 2013
• Primary Completion: June 20, 2017
• Study Completion: July 30, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

PT (1)