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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04214054
Enrollment
20
Registered
2019-12-30
Start date
2018-05-13
Completion date
2019-09-25
Last updated
2020-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Sinus Augmentation

Keywords

maxillary sinus lift, Piezosurgery, Grafting materials

Brief summary

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

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.

Interventions

OTHERMoldable self-hardening biphasic calcium phosphate graft

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.

PROCEDURENo graft material placed - Blood Clot only

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.

Sponsors

Alexandria University
CollaboratorOTHER
Nourhan M.Aly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This study was designed as a randomized controlled clinical trial and the participants were allocated randomly into two equal groups.

Eligibility

Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Evaluation1 weekPain was assessed through on a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Wound healing1 weekThe 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.
Radiographic Evaluation6 monthsCone 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.
Implant stability6 monthsExamining 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026