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

NCT04214054 | Completed

• 1 other identifier: BCP for maxillary sinus lift
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillary Sinus Augmentation

Keywords

maxillary sinus lift; Piezosurgery; Grafting materials

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Moldable self-hardening biphasic calcium phosphate graft

EXPERIMENTAL

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

No graft material

PLACEBO COMPARATOR

Procedure: No graft material placed - Blood Clot only

Interventions

Moldable self-hardening biphasic calcium phosphate graft OTHER

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.

Moldable self-hardening biphasic calcium phosphate graft

No graft material placed - Blood Clot only PROCEDURE

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.

No graft material

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients with systemic diseases that directly affect the surgical procedure and/ or the healing of the bone
• immunocompromised status
• Alcoholism
• psychiatric disorders
• Parafunctional habits

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (3)

• Mazor Z, Horowitz RA, Del Corso M, Prasad HS, Rohrer MD, Dohan Ehrenfest DM. Sinus floor augmentation with simultaneous implant placement using Choukroun's platelet-rich fibrin as the sole grafting material: a radiologic and histologic study at 6 months. J Periodontol. 2009 Dec;80(12):2056-64. doi: 10.1902/jop.2009.090252.

  PMID: 19961389 BACKGROUND

• Del Fabbro M, Testori T, Francetti L, Weinstein R. Systematic review of survival rates for implants placed in the grafted maxillary sinus. Int J Periodontics Restorative Dent. 2004 Dec;24(6):565-77.

  PMID: 15626319 BACKGROUND

• Cha HS, Kim A, Nowzari H, Chang HS, Ahn KM. Simultaneous sinus lift and implant installation: prospective study of consecutive two hundred seventeen sinus lift and four hundred sixty-two implants. Clin Implant Dent Relat Res. 2014 Jun;16(3):337-47. doi: 10.1111/cid.12012. Epub 2012 Nov 15.

  PMID: 23157674 BACKGROUND

Study Officials

• Shaimaa A. El Sadek, M.Sc

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Ahmed A. A. Sharara, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Magda M Saleh, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Nevien Shawky, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor of Dental Public Health

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

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: December 30, 2019
• Study Start: May 13, 2018
• Primary Completion: April 20, 2019
• Study Completion: September 25, 2019
• Last Updated: August 20, 2020

Record last verified: 2020-08

Locations

EG (1)