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

NCT ID: NCT01836744

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-18
• Study Completion Date: 2023-07-30

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.

Detailed Description

The study will be performance in 12 patients submitted to a bilateral sinus lift procedure.

Six months after the bilateral sinus lifting performed in a randomly way, using as graft materials (100% of autologous bone graft or 100% of xenograft), will be placed 1 to 3 implants in each maxillary sinus.

Wait more six months to expose the implant. At the end of 13 months after implant placement it should be in charge.

Implant placement (6 months after sinus lift procedure):

• Both sides should be treated during the same session.
• Patients will receive 2g Amoxicillin one hour before the procedure. Patients allergic to penicillin will be given Clindamycin 600 mg 1 hour before implant placement procedure.
• Patients will rinse for 1 minute prior to flap elevation with 0.12% chlorhexidine mouthwash.
• After delivery of local anaesthesia, incision and flap elevation, the recommendation of the various implant manufacturers will be followed for placing 1 to 3 implants 9-11 mm long per posterior upper (premolar-molar areas) below the maxillary sinus and a histological sample for each side will be collected.
• The neck of the implants will be placed flush to the bone and implants will be submerged under the soft tissues and flaps will be sutured.
• Baseline intraoral radiographs of the study implants have to be taken.

Post-implant placement instructions:

• Chlorhexidine mouthwash 0.12% for 1 minute twice a day for 2 weeks.
• Ibuprofen 400 mg will be prescribed to be taken 2-4 times a day during meals, but patients will be instructed not to take them in absence of pain. Patients with gastric problems or allergic to ibuprofen will receive paracetamol 1 g instead.
• Sutures will be removed after 10 days.

Abutment connection (6 months after implant placement):

• Both sides should be treated during the same session.
• Patients will rinse for 1 minute prior to flap incision with 0.12% chlorhexidine mouthwash.
• Mucosa can be punched or a flap will be elevated according to personal preference of the surgeon, it is important that both sides are treated in the same way.
• Individual implants will be tested for stability.
• Impressions will be taken.
• Healing abutments will be placed.

Post-abutment connection instructions:

• Chlorhexidine mouthwash 0.12% for 1 minute twice a day for 2 weeks.
• Ibuprofen 400 mg will be prescribed to be taken 2-4 times a day during meals, but patients will be instructed not to take them in absence of pain. Patients with gastric problems or allergic to ibuprofen will receive paracetamol 1 g instead.
• Sutures will be removed after 10 days.

Prosthetic phase:

• Within one month after abutment connection, implants will be manually tested for stability.
• Provisional reinforced acrylic restorations or definitive screw-retained or provisionally cemented (to allow implant stability assessment) metal-resin or metal-ceramic bridges rigidly joining the 2 or 3 implants will be delivered.
• Implants will be splinted under the same prosthesis, each implant supporting one tooth element.
• The connection of teeth with implants under the same prosthesis is not allowed.
• Similar procedures and materials have to be used in the same patient.
• The occlusal surface will be in slight contact with the opposite dentition.
• Intraoral radiographs and clinical pictures of the study implants will be taken at initial loading.

Maintenance:

• All patients will be recalled every 6 months after prosthetic loading for delivery of professional maintenance on individual basis.
• Dental occlusion will be evaluated at each maintenance visit.

Conditions

Dental Implant Survival Rate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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;

Group Type: ACTIVE_COMPARATOR

Survival rate dental implant (OsseoSpeed™)

Intervention Type: DEVICE

survival rate axenograft material

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

Group Type: ACTIVE_COMPARATOR

Survival rate dental implant (OsseoSpeed™)

Intervention Type: DEVICE

Interventions

Survival rate dental implant (OsseoSpeed™)

Intervention Type: DEVICE

Other Intervention Names

OsseoSpeed™ dental implant

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade do Porto

OTHER

Sponsor Role: collaborator

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role: collaborator

Tecnoss OsteoBiol

UNKNOWN

Sponsor Role: collaborator

Grupo de Investigação: Cirurgia Oral, Peridontologia, Implantologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco Correia, DDS, Msc, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Ricardo Faria Almeida, DDS, Msc, PhD

Role: STUDY_DIRECTOR

Universidade do Porto

Antonio Campos Felino, DDS, PhD

Role: STUDY_CHAIR

Universidade do Porto

Sonia Gouveia, Phd

Role: STUDY_CHAIR

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

Daniel H Pozza, DDS, PhD

Role: STUDY_CHAIR

Departamento de Biomedicina da Faculdade de Medicina, and Faculdade de Ciências da Nutrição e Alimentação, and I3s, Universidade do Porto, Porto, Portugal.

Locations

University of Porto, Faculty of Dental Medicine

Porto, Porto District, Portugal

Countries

Portugal

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/20238367

Related Info

Other Identifiers

D-2012-024

Identifier Type: -

Identifier Source: org_study_id