Implant Placement Using Open Sinus Elevation Technique With and Without Bone Grafting Material

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorMisr International University

About this trial

The success rate of dental implants after graftless sinus augmentation versus conventional sinus augmentation surgery in atrophic maxillae in edentulous patients was investigated and it was concluded that despite the bone gain in ten garftless side, implant survival were significantly lower in the non-grafted side. One year later, Lie et al., conducted a systematic review to evaluate efficacy of graftless maxillary sinus membrane elevation using the lateral window approach for implantation in the atrophic maxilla. It showed a high implant survival rate in non-grafted maxillary sinus lifts and conventional sinus lifts using augmentation materials and there was no significant difference in the ISQ values between both procedures. However, further randomized clinical trials with long-term follow-up were recommended.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Edentulous atrophic posterior maxillary ridge.

Residual alveolar ridge height within 3-5mm.

At least 2mm band of keratinized tissue.

Patients with good oral hygiene.

Disqualifiers

Medically compromised patients.

Smokers.

Pregnant females.

Patients with active periodontal disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Open sinus lifting without bone grafting and simultaneous implant placement

    Procedure/Surgery

    no bone graft will be used after open sinus lifting

  • Open sinus lifting with bone grafting and simultaneous implant placement

    Procedure/Surgery

    bone graft will be packed palatally after open sinus elevation and before implant placement, then implant placement will took place followed by packing of bone grafts

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Open sinus lifting without bone grafting and simultaneous implant placementExperimental treatment 1 intervention
Group B: Open sinus lifting with bone grafting and simultaneous implant placementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Long- term Implant Stability

Resonance frequency analysis will be employed with a dedicated device (Osstell).

Time frame
12 months

Secondary outcomes

1

Implant survivability

Individual unattached implant that is immobile when tested clinically, radiography that does not demonstrate evidence of peri-implant radiolucency, Bone loss that is less than 0.2 mm annually after the implant's first year of service, No persistent pain, discomfort or infection

Time frame
12 months
2

Vertical bone height formed

CBCTS

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

This trial is not recruiting at the moment. You can still explore other options: