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NCT Number: NCT06723678

Evaluation of Bone Changes Around Implants in Patients Treated With All on Four

The Goal of the clinical trail is to evaluate the Bone height changes around two axially placed anterior implants and two distally inclined 30-degree angle posterior implants in comparison to two axially placed anterior implants and two distally inclined 45-degree angle posterior implants using cone beam CT (CBCT).

Patients will visit the clinic after the surgery and after the framework and denture insertion for check ups and during the follow up periods ( at denture insertion, 6 months and 12 months)

Recruiting

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Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University Girls Branch

Cairo, Nasr City, 4450001, Egypt

Location status: Recruiting

Location contact

Maiada M Awadd, Lecturer

SUB_INVESTIGATOR

Noha T Kamel, Lecturer

PRINCIPAL_INVESTIGATOR

Noha T Kamel, lecturer

CONTACT

[email protected]

+0201112295457

Rehab A Soliman, Lecturer

CONTACT

[email protected]

+2010023235360

Rehab A Soliman, Lecturer

SUB_INVESTIGATOR

Sara A Elkady, Lecturer

SUB_INVESTIGATOR

About this study

All patients will receive upper complete dentures and mandibular All on-4 screw-retained prosthesis. The upper complete denture will be mucosa supported and the lower will be All on-4 screw-retained prosthesis. Patients will be divided into two equal groups; Group I will receive two axially placed anterior implants and two distally inclined 30-degree angle posterior implants, while Group II will receive two axially placed anterior implants and two distally inclined 45-degree angle posterior implants.

Both groups will be functionally loaded after three months of insertion. Bone height changes around axial and distally inclined implants will be evaluated using cone beam CT (CBCT), All records will be taken at time of denture insertion, 6 and 12 months later.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients' ages must range from 50-65 years old.
  • All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
  • Patients should be free from any metabolic or bone disorders that contraindicate implant installation.
  • All patients must have sufficient inter arch space

Exclusion criteria

  • Patients with oral or systemic diseases.
  • Patients with xerostomia or excessive salivation.
  • Patients with parafunctional habits (bruxism or clenching).
  • Heavy smoker or alcoholic patients.
  • Patients with history of temporo-mandibular dysfunction.
  • Patients with brain disorders or psychiatric disorders

Treatment and study plan

Two distally inclined 45-degree angle posterior implants

Procedure

During the surgery, two axially placed anterior implants and two distally inclined 45-degree angle posterior implants will be placed, after healing period, All on-4 screw-retained prosthesis will be delivered to the patients.

Two distally inclined 30-degree angle posterior implants

Procedure

During the surgery, two axially placed anterior implants and two distally inclined 30-degree angle posterior implants will be placed, after healing period, All on-4 screw-retained prosthesis will be delivered to the patients

Primary outcomes

  1. Bone Height Changes

    Time frame: All records will be taken at time of denture insertion, 6 and 12 months later.

    Bone height changes around axially placed anterior implants and distally inclined posterior implants will be evaluated using cone beam CT (CBCT)

Study contacts

Contact information is provided by the study sponsor or research team.

Noha T Kamel, Lecturer

CONTACT

[email protected]

+201112295457

Rehab A Soliman, Lecturer

CONTACT

[email protected]

+201023235360

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Radiographic Evaluation of Crestal Bone Changes Around Implants in Patients Treated With Delayed Loaded All on Four (Randomized Clinical Trail)

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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