Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMisr International University
About this trial
Implant supported dental restorations are sometimes challenging with decreased bone height in the posterior maxilla. The goal of this study is to test an augmentation bone substitute in elevating the maxillary sinus floor; in terms of soft tissue reaction, formed bone height as well as structure.
Bone substitute will be compared to a graftless method of bone augmentation depending on participants' bodies forming bone in the defective area.
Participants will:
* Undergo lateral maxillary sinus floor elevation with bone substitute or graftless method. * Record postoperative swelling and pain through the follow up period. * Take radiographs for evaluation of the formed bone before placing dental implants.
Eligibility criteria
Qualifiers
Adult male/female patients above the age of 18.
Patients with one or more teeth requiring implant supported dental restoration in atrophic posterior maxilla.
Alveolar bone height less than 5 mm at the defective site.
Good oral hygiene.
Disqualifiers
Medically compromised patients with conditions contraindicating surgery (eg. uncontrolled diabetics, bisphosphonate intake, radio or chemotherapy).
Patients with active infection at or related to the site of surgery (eg. acute sinusitis).
Heavy smokers.
Patients not indicated for an implant supported restoration at the time of enrollement.
Trial design
Treatments tested in this trial
- Xenograft
- maxillary sinus membrane elevation and stabilization.
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov