Health TrialsbyHealthPanel

Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation

ConditionsMaxillary Sinus Floor AugmentationMaxillary Sinus ElevationBone 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Xenograft

    Biological/Vaccine

    hydrogel-enhanced xenograft

  • maxillary sinus membrane elevation and stabilization.

    Other intervention

    graftless augmentation of the maxillary sinus floor through membrane elevation and stabilization; tenting.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: control groupActive comparator 1 intervention
Group B: study groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

bone height gain

radiographically, through CBCT

Time frame
8 months

Secondary outcomes

1

patient centered edema measurement

linear measurements between specific reference points on the face

Time frame
0-7 days
2

patient reported/related edema estimate

patients' assessment of swelling according to visual scale for edema

Time frame
3-7 days
3

VAS pain

patients' assessment of pain 0-10 daily

Time frame
10 days
4

bone structure

histological examination of harvested bone under microscope

Time frame
8 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Misr International University

Lead sponsor

Source ClinicalTrials.gov
Apply now