Clinical trial NCT05108324: Reliability of All on 4 Using 2 Zygomatic and 2 Conventional Implants vs All on 4 Implants for Rehabilitation of Maxilla
Official title: Reliability of All on Four Using 2 Zygomatic and 2 Conventional Implants Versus Conventional All on Four Implants Simultaneously for the Rehabilitation of the Atrophied Maxilla (A Randomized Control Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous; Alveolar Process, Atrophy
Keywords: all on four
zygomatic implant
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a randomized controlled trial - parallel group with the patients. It is a superiority trial.

study group are 10 patients receiving 2 zygomatic implants with 2 conventional implant in anterior region, while the control group are another 10 patients receiving 4 conventional implant 2 in anterior region and 2 in posterior region with immediate loading.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Oral rehabilitation by dental implants in the severely atrophic maxilla often represents a challenge. To overcome this difficulty, bone augmentation procedures such as sinus augmentation, guided bone regeneration (GBR), or distraction osteogenesis have been used to obtain adequate bone height and width for proper three-dimensional implant placement. To avoid surgical morbidity and shorten treatment length, alternative methods such as short or tilted implants, as well as zygomatic implants (ZIs),have been proposed and have shown promising outcomes.

Detailed description: Placement of dental implants in the pterygo-maxillary region provides adequate posterior bone support for the prosthesis which permits better distribution of masticatory forces without the need of sinus floor augmentation, onlay and inlay grafts, split crest technique, or osteogenic distraction. This allows rehabilitating patients with satisfactory full arch fixed maxillary prosthesis, which is usually spanned from second molar to contralateral second molar tooth.

The purpose of the present study is to compare the Reliability of all on four by 2 zygomatic implants with 2 conventional implant in anterior region versus all on four approach by conventional implant for the rehabilitation of the atrophied maxilla in terms of survival rates and improving the quality of patient's life and involved complication with maxillary sinus.

Eligibility criteria: Inclusion Criteria:

1. Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored with other type of treatment.
2. Patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of at least 2 conventional implants.

Exclusion Criteria:

1. Patients with any systemic disease that might interfere with dental implants placement and/or osseointegration e.g. uncontrolled diabetes, hypertension and osteoporosis, etc.
2. Heavy smoker (\> 20 cigarettes daily) and patients with history para-functional habits (e.g. clenching or bruxism, etc.) were also excluded.
3. Intraoral pathological lesion, related to maxilla, maxillary sinus and zygoma.

Primary outcomes:
measure: change of function of the masticatory muscles
timeFrame: baseline & 6 month after the delivery of the prothesis
Secondary outcomes:
measure: Implant primary stability
timeFrame: baseline Immediate after implantation
Other outcomes:
measure: Biologic complication and implant survival rate
timeFrame: baseline and sixth months
Locations:
Study officials:
affiliation: Cairo University
name: Mohamed a. Atef, professor
role: STUDY_CHAIR
References: