Graftless Lateral Maxillary Sinus Lift Balloon by Different Antrostomy Sizes With Simultaneous Implant Placement

Study Overview
=================
Brief Summary
-----------------
two groups undergo for graftless sinus lift using AMBE (antral membrane balloon elevation) through different antrostomy size with simultaneous implant placement

Detailed Description
-----------------
control group undergoes for graftless sinus lift using AMBE through large antrostomy with simultaneous implant placement. While, study group undergo for graftless sinus lift using AMBE through small antrostomy with simultaneous implant placement. the aim of the study is assessment the effect of antrostomy size on bone formation in graftless sinus lift with simultaneous implant placement. CBCT will be done before and after the surgery and after 6 months to assess of amount bone gain in mm. implant stability after 6 months will be determined by using Osstell. Primary outcome: amount of bone gain which will be measured by using linear measurement from CBCT. secondary outcome: stability of implant by using osstell

Official Title
-----------------
Assessment of the Effect of the Antrostomy Size in Graftless Lateral Maxillary Sinus Floor Elevation Using AMBE (Antral Membrane Balloon Elevation) With Simultaneous Implant Placement

Conditions
-----------------
Atrophy of Edentulous Maxillary Alveolar Ridge

Intervention / Treatment
-----------------
* Procedure: maxillary sinus lift


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with atrophic maxilla and pneumatization of maxillary sinus with residual bone height from 3-6mm. Both sexes No intraoral soft and hard tissue pathology, No systemic condition that contraindicate implant placement Exclusion Criteria: Sinus pathology. Heavy smokers more than 20 cigarettes per day. Patients with systemic disease that may affect normal healing. Psychiatric problems. Disorders to implant are related to history of radiation therapy to head and neck neoplasia or bone augmentation to implant site

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: assessment of the effect of the antrostomy size in graftless lateral maxillary sinus floor elevation using AMBE (antral membrane balloon elevation) with simultaneous implant placement
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: maxillary sinus lift small antrostomy<br>local anaesthesia will be given flap will be reflected to expose sinus lateral wall. round diamond bur will be used to make small antrostomy and expose schneiderian membrane. maxillary sinus lift by using antral membrane balloon elevation without using graft material with simultaneous implant placement | Procedure: maxillary sinus lift<br>* maxillary sinus floor elevation by using balloon through either small or large antrostomy without using graft material with simultaneous implant placement<br>* Other names: implant placement;|
| Active Comparator: maxillary sinus lift large antrostomy<br>local anaesthesia will be given flap will be reflected to expose sinus lateral wall round diamond bur will be used to make large antrostomy and expose schneiderian membrane. maxillary sinus lift by using antral membrane balloon elevation without using graft material with simultaneous implant placement | Procedure: maxillary sinus lift<br>* maxillary sinus floor elevation by using balloon through either small or large antrostomy without using graft material with simultaneous implant placement<br>* Other names: implant placement;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of bone formation | measurement of amount of bone gained by using CBCT | after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant stability | measurement of implant stability by using osstell | after 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sinus augmentation,lifting