Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation | NCT07737704

NCT07737704

Overview

NCT ID: NCT07737704
Lead Sponsor: Misr International UniversityOTHER
Official Title: Clinical, Radiographic and Histologic Assessment of a New Xenograft Enhanced With Hydrogel in Augmentation of the Maxillary Sinus: A Randomized Controlled Trial
Brief Summary: 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.
Conditions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Patient's consensual agreement to be enrolled in the study.

Exclusion Criteria:

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.

(Patients developing any medical condition that interferes with the outcomes after enrolment in the study will be excluded).

Central Contacts: Ramy H El Shater, MDSContact
ramy.hamdy@miuegypt.edu.eg+201014111431