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Completed

NCT Number: NCT04214054

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

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.

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Key information

Conditions

Maxillary Sinus Augmentation

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 30, 2019
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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