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

Not Applicable

Completed

• Conditions: Maxillary Sinus Augmentation
• Interventions: Procedure: No graft material placed - Blood Clot only; Other: Moldable self-hardening biphasic calcium phosphate graft

• Registration Number: NCT04214054
• Lead Sponsor: Nourhan M.Aly

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.

Study Timeline

• Study Start: 2018-05-13
• Primary Completion: 2019-04-20
• Study Completion: 2019-09-25
• Study First Submitted: 2019-12-26
• Study First Submitted QC: 2019-12-26
• Study First Posted: 2019-12-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No graft material	No graft material placed - Blood Clot only	-
Moldable self-hardening biphasic calcium phosphate graft	Moldable self-hardening biphasic calcium phosphate graft	Easy graft, a moldable osteocondutive allograft formed of 60% hydroxylapatite and 40% β-tricalcium phosphate (Easy-graft, Sunstar, Gruidor, Degradable solutions AG, Swizerlard).

Primary Outcome Measures

Name	Time	Method
Radiographic Evaluation	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	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	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	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt