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Clinical Trials/NCT04214054
NCT04214054
Completed
Not Applicable

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

Nourhan M.Aly1 site in 1 country20 target enrollmentMay 13, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maxillary Sinus Augmentation
Sponsor
Nourhan M.Aly
Enrollment
20
Locations
1
Primary Endpoint
Radiographic Evaluation
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 13, 2018
End Date
September 25, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nourhan M.Aly
Responsible Party
Sponsor Investigator
Principal Investigator

Nourhan M.Aly

Instructor of Dental Public Health

University of Alexandria

Eligibility Criteria

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

Outcomes

Primary Outcomes

Radiographic Evaluation

Time Frame: 6 months

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.

Pain Evaluation

Time Frame: 1 week

Pain was assessed through on a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)

Implant stability

Time Frame: 6 months

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.

Wound healing

Time Frame: 1 week

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.

Study Sites (1)

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