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

Nourhan M.Aly

Status: Completed

Conditions: Maxillary Sinus Augmentation

Treatments: Procedure: No graft material placed - Blood Clot only; Other: Moldable self-hardening biphasic calcium phosphate graft

Study type: Interventional

Funder types: Other

Identifiers

NCT04214054

BCP for maxillary sinus lift

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

Moldable self-hardening biphasic calcium phosphate graft

Experimental group

Description:

Easy graft, a moldable osteocondutive allograft formed of 60% hydroxylapatite and 40% β-tricalcium phosphate (Easy-graft, Sunstar, Gruidor, Degradable solutions AG, Swizerlard).

Treatment:

Other: Moldable self-hardening biphasic calcium phosphate graft

No graft material

Placebo Comparator group

Treatment:

Procedure: No graft material placed - Blood Clot only