Maxillary Sinus Lift With and Without Self-hardening Biphasic Calcium Phosphate.

Study Overview
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Brief Summary
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This study was carried out to compare the outcome of sinus lift without grafting material, versus the use of moldable, self hardening calcium phosphate biomaterials with simultaneous implant placement.

Detailed Description
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This study was designed as a randomized controlled clinical trial, the study population consisted of 20 patients with missing maxillary posterior teeth and residual bone height 5-7mm. The sample was selected conveniently according to a list of inclusion and exclusion criteria, the participants were allocated randomly into two equal groups. All patients had sinus lift using piezosurgery device with simultaneous implant placement. In group I, blood clot was the only filling material. In group II, moldable, self-hardening calcium phosphate was the filling material. Clinical and radiographic evaluations were done through 6 months postoperatively.

Official Title
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Maxillary Sinus Lift With and Without Self Hardening Biphasic Calcium Phosphate and Simultaneous Implant Placement

Conditions
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Maxillary Sinus Augmentation

Intervention / Treatment
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* Other: Moldable self-hardening biphasic calcium phosphate graft
* Procedure: No graft material placed - Blood Clot only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients having missing posterior maxillary teeth The vertical height between the floor of the maxillary sinus and the alveolar crest ranged between 5 and 7mm, Free from maxillary sinus pathologies Adequate oral hygiene Acceptable interarch space for the prosthesis Exclusion Criteria: Patients with systemic diseases that directly affect the surgical procedure and/ or the healing of the bone immunocompromised status Alcoholism psychiatric disorders Parafunctional habits

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study was designed as a randomized controlled clinical trial and the participants were allocated randomly into two equal groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moldable self-hardening biphasic calcium phosphate graft<br>Easy graft, a moldable osteocondutive allograft formed of 60% hydroxylapatite and 40% β-tricalcium phosphate (Easy-graft, Sunstar, Gruidor, Degradable solutions AG, Swizerlard). | Other: Moldable self-hardening biphasic calcium phosphate graft<br>* Incision was performed in the canine area then a full thickness mucoperiosteal flap was elevated and exposure of the lateral aspect of the maxillary sinus. Osteotomy of the buccal window was performed using the piezosurgery device followed by meticulous dissection of the sinus membrane. Drilling the site were implants were to be placed, guided by the preformed surgical stent. Implants of appropriate size were torqued to engage the apical aspect of the implant recipient site. The sinus was augmented with moldable self-hardening biphasic calcium phosphate. Repositioning and suturing of the flap using 3-0 black silk suture material.<br>|
| Placebo Comparator: No graft material<br> | Procedure: No graft material placed - Blood Clot only<br>* A pyramidal full thickness mucoperiosteal flap was performed distal to the canine area with a crestal incision located palatally in the edentulous area and vertical extension of the incision to the buccal vestibule using Bard Parker blade number 15. The flap was reflected exposing the alveolar bone. Lateral window was performed and the sinus membrane was elevated using piezo surgery. Drilling at the sites where implants were to be placed was done using Neobiotech implant drilling Kit. Implants. Implants were placed in a self-tapping fashion using a torque wrench. Flaps were replaced back and sutured using 3-0 black silk suture material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Evaluation | Pain was assessed through on a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe) | 1 week | 
| Wound healing | The presence of alveolar osteitis (dry socket) will be determined clinically using BLUM'S criteria. Wound healing was assessed and recorded depending on the absence or presence of dehiscence, every opening along the incision will be recorded as dehiscence , dental tweezers will be used to identify it. | 1 week | 
| Radiographic Evaluation | Cone beam computed tomography (CBCT) was done. The apparatus and the settings were kept the same during all the preoperative scans to evaluate the amount of vertical bone height gained, the change of bone density and the marginal bone loss postoperatively. | 6 months | 
| Implant stability | Examining implant stability was done using Osstell (Osstell co. Swedan). It is a noninvasive and easy-to-use system to determine implant stability and to assess the process of osseointegration. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maxillary sinus lift, Piezosurgery, Grafting materials