Reliability of All on 4 Using 2 Zygomatic and 2 Conventional Implants vs All on 4 Implants for Rehabilitation of Maxilla

Edentulous; Alveolar Process, Atrophy Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05108324
• Other study ID #: 10/11/2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 10, 2021
• Est. completion date: February 14, 2023

Study information

• Verified date: November 2021
• Source: Cairo University
• Contact: MOSTAFA EL MASRY, doctor
• Phone: +201221953838
• Email: mostafa.elmasry[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 14, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Edentulous; Alveolar Process, Atrophy

Intervention

Procedure:
• zygomatic implant
2 zygomatic implants and 2 anterior conventional implant
• conventional implant
patients will receive 4 conventional dental implant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biologic complication and implant survival rate	Any biological complication as sinusitis, fenestration, orbital insults, failure of the implant, are going to be assessed radiographically by the CBCT	baseline and sixth months
Primary	change of function of the masticatory muscles	measuring muscles activtiy of masseter and temporalis muscles by electromyography	baseline & 6 month after the delivery of the prothesis
Secondary	Implant primary stability	The implant initial stability will be directly measured after implant insertion using the resonance frequency analysis technique by osttel device	baseline Immediate after implantation