Clinical trial NCT03590964: One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis
Official title: One-stage Maxillary Sinus Elevation Using a Bone Core Containing an Implant From the Mandibular Symphysis: (A Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrophied Posterior Maxilla
Keywords: Implant, Bone ring, Sinus lift.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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. \]

Primary outcomes:
measure: Survival rate of implant
timeFrame: One year post-operative.
Secondary outcomes:
measure: Marginal bone loss around implant
timeFrame: one year post operative
measure: Pain intensity
timeFrame: One month post-operative.
measure: Sinus membrane perforation
timeFrame: During operation
measure: Established bone integration
timeFrame: Six months post operative.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine-Cairo University.
state: Giza
Study officials:
affiliation: Faculty of Oral and Dental Medicine- Cairo University
name: Salah Y yassin, PhD.
role: STUDY_DIRECTOR
References:
citation: Mahesh L, Kurtzman GM, Shukla S. Trephine core: an alternative sinus lift technique. J Oral Implantol. 2014 Jul;40 Spec No:391-6. doi: 10.1563/aaid-joi-D-14-00047. Epub 2014 Mar 12. No abstract available.
citation: Wallace SS, Froum SJ. Effect of maxillary sinus augmentation on the survival of endosseous dental implants. A systematic review. Ann Periodontol. 2003 Dec;8(1):328-43. doi: 10.1902/annals.2003.8.1.328.
citation: Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.
citation: Wang PD, Klein S, Kaufman E. One-stage maxillary sinus elevation using a bone core containing a preosseointegrated implant from the mandibular symphysis. Int J Periodontics Restorative Dent. 2002 Oct;22(5):435-9.