Enhanced hydrogel xenograft for open maxillary sinus augmentation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, interventional study compares a hydrogel-enhanced xenograft to a graftless approach for lateral maxillary sinus floor elevation in adults with severe posterior maxillary atrophy. Participants undergo sinus elevation with either the xenograft or a graftless method, followed by monitoring of swelling and pain and radiographic evaluation of newly formed bone before implant placement. Outcomes include soft tissue reaction, quantity and quality of formed bone, and radiographic changes over a staged augmentation process. The null hypothesis is that there is no difference between the two methods in tissue response and bone formation. Thirty sites will be studied at two Suez Canal University locations under Misr International University sponsorship.

Why it matters

Who can join: the full rules

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).

Where it's running

• Suez Canal University
  Ismailia, Ismailia Governorate, Egypt Recruiting
• Suez Canal University
  Ismailia, Egypt Recruiting
• Suez Canal University
  Ismailia, Egypt Recruiting

Study contacts

• Study coordinator: Ramy H El Shater, MDS
• Email: ramy.hamdy@miuegypt.edu.eg
• Phone: +201014111431

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.