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One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis

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ClinicalTrials.gov Identifier: NCT03590964
Recruitment Status : Recruiting
First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed kamel hassan, Cairo University

Brief Summary:

Two groups of patients with atrophy in posterior maxilla indicated for sinus lift.

First group will be subjected to open sinus lift with chin bone graft. Second group will be subjected to sinus floor elevation using a bone ring.


Condition or disease Intervention/treatment Phase
Atrophied Posterior Maxilla Procedure: Open sinus lift using chin bone graft Procedure: Sinus lift using bone ring containing the implant. Not Applicable

Detailed Description:

Two groups of patients with atrophy in posterior maxilla indicated for sinus lift.

(A) First group will be subjected to open sinus lift with chin bone graft.

  • All cases will undergo surgery under general anesthesia for sinus lift and other surgery under local anesthesia for implant placement .
  • Exposure of the anterior wall of maxilla according to standardized surgical approach.
  • Open sinus lift and bone graft.
  • After 6 months, implant will be drilled and inserted in the recipient site according to standard protocol.
  • Loading on implant after 5-6 months.

(B)Second group will be subjected to sinus floor elevation using a bone ring.

  • All cases will undergo surgery under local anesthesia for implant placement in the mandibular chin and other surgery under general anesthesia for sinus lift using bone ring with the implant.
  • Exposure of the mandibular chin will be done under local anesthesia using a standardized surgical approach.
  • Implant will be drilled and inserted in the chin according to standard protocol.
  • After 3 months, second surgery under general anesthesia to place the implant and surrounding ring in the atrophied posterior maxilla.
  • The bone ring containing the implant allowed to heal for 5-6 months.

Follow up:

  • Clinical evaluation will be performed at the first week post-operative.
  • Three months post-operative second surgery to put the implant with surrounding ring in atrophied posterior maxilla.
  • Five months post-operative to the second surgery, implant will be loaded with the final restoration.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • A Randomized controlled trial.
  • Parallel group study.
  • A trial will be carried out in hospital of Oral and Maxillofacial surgery department- Faculty of Oral and Dental Medicine Cairo University
  • Equal randomization: participants with equal probabilities for intervention.
  • Positive controlled: Both groups receiving treatment.
Masking: None (Open Label)
Masking Description: Because the two interventions used in this trial are clearly different and easily recognized by the participants and investigators, neither the investigators nor participants can be blinded.
Primary Purpose: Treatment
Official Title: One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis: (A Randomized Controlled Trial)
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Active Comparator: Open sinus lift using chin bone graft
Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach.
Procedure: Open sinus lift using chin bone graft
Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach.
Other Name: Lateral sinus approach with chin graft

Experimental: Sinus lift using bone ring containing the implant
Patients with atrophied posterior maxilla will undergo sinus lift using bone ring containing the implant.
Procedure: Sinus lift using bone ring containing the implant.
Patients with atrophied posterior maxilla will undergo sinus lift with chin bone ring containing the implant.
Other Name: One stage sinus lift using bone ring




Primary Outcome Measures :
  1. Survival rate of implant [ Time Frame: One year post-operative. ]
    The estimated annual failure rate will be assessed via clinical assessment, measuring unit (Binary yes\ no)


Secondary Outcome Measures :
  1. Marginal bone loss around implant [ Time Frame: one year post operative ]
    Bone loss around implant will be assessed using Cone Beam Computed Tomography, measuring unit (millimeter).

  2. Pain intensity [ Time Frame: One month post-operative. ]
    Intensity of pain will be assessed using Visual analog scale (0 -10), 0 indicate no pain,10 indicate unbearable pain.

  3. Sinus membrane perforation [ Time Frame: During operation ]
    Perforation of sinus lining will be assessed clinically, (Binary yes\no).

  4. Established bone integration [ Time Frame: Six months post operative. ]
    Structural and functional integration of bone around implant will be assessed using a device with measuring unit scale of 1-100.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with at least a unilateral atrophied posterior maxilla indicated for open sinus lift and graft.
  2. All ages and both sexes were included in this study.
  3. Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
  4. Patients with good general condition allowing surgical procedure under general anesthesia.
  5. Patients with physical and psychological tolerance.

Exclusion Criteria:

  1. Patients with high risk systemic diseases like uncontrolled diabetes. As uncontrolled diabetes has a negative impact on normal bone healing.
  2. Patients with chronic sinusitis, maxillary sinus tumor or cyst. As they will affect accuracy of the procedure.
  3. Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. ]

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): NCT03590964


Contacts
Contact: Mohamed K Hassan, MSc. 01111284444 dr_mkdentistry@yahoo.com

Locations
Egypt
Faculty of Oral and Dental Medicine-Cairo University. Recruiting
Cairo, Giza, Egypt, 12613
Contact: Mohamed K Hassan, MSc    01111284444    dr_mkdentistry@yahoo.com   
Sponsors and Collaborators
Cairo University
Investigators
Study Director: Salah Y yassin, PhD. Faculty of Oral and Dental Medicine- Cairo University