Clinical trial NCT04214054: Maxillary Sinus Lift With and Without Self-hardening Biphasic Calcium Phosphate.
Official title: Maxillary Sinus Lift With and Without Self Hardening Biphasic Calcium Phosphate and Simultaneous Implant Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Sinus Augmentation
Keywords: maxillary sinus lift
Piezosurgery
Grafting materials
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2019-12-30
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was designed as a randomized controlled clinical trial and the participants were allocated randomly into two equal groups.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Evaluation
timeFrame: 1 week
measure: Wound healing
timeFrame: 1 week
measure: Radiographic Evaluation
timeFrame: 6 months
measure: Implant stability
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Shaimaa A. El Sadek, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Ahmed A. A. Sharara, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Magda M Saleh, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Nevien Shawky, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.