Implants Placed With Crestal Sinus Approach Versus Osseodensification in Atrophic Posterior Maxilla

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

About this trial

However, recently, most described techniques for posterior atrophic maxillary rehabilitation, are targeting more conservative, cost-effective and efficient methods for sinus elevation eliminating its lateral access. The aim of the present study is to evaluate and compare the long-term implant stability for implants placed by the novel crestal sinus approach versus osseodensification using Densa-bur in Atrophic Posterior Maxilla.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Edentulous atrophic posterior maxillary ridge.

Residual alveolar ridge height within 5-6 mm.

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

  • implant placement using crestal sinus approach

    Procedure/Surgery

    a Full thickness flap will be elevated at the edentulous site with two vertical releasing incision. After flap reflection, the preparation of osteotomy will be prepared following standard implant system protocol preparation of the osteotomy. Drilling will be done gently till reaching 0-1mm from the sinus floor, then implant placement will take place and the implant itself will be used to gently elevate the sinus up to 3-5mm

  • Implant placement using osseodensification

    Procedure/Surgery

    The implant motor will be adjusted on reverse mode with 800 to 1200 rpm. According to the desired implant dimension, Densah bur diameter will be used and then implant placement.

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Implant placement using crestal sinus approachExperimental treatment 1 intervention
Group B: Implant placement using osseodensificationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Long- term Implant Stability

Resonance frequency analysis will be employed with a dedicated device (Osstell). For each implant, implant stability quotient ISQ values will measured from the four sites (mesial, distal, buccal, and palatal sites). The mean of all measurements will be rounded to a whole number and regarded as the final ISQ of the implant. ISQ values will obtained after implant placement (T1), after loading (T2), 6 months after loading (T3) follow up intervals.

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

using CBCTs 1

Time frame
12 months
3

Post operative pain

will be recorded by the patient for 10 days after the surgery The patients will mark the pain perception in a non-numerical 100 mm line ranging from "no pain=0" (left) to "very painful=100" (right). It will be given a numerical value by measuring in millimeters the distance from the left end of the line

Time frame
10 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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