Prosthetic Management of All on Four Versus All on Six to Rehabilitate Completely Edentulous Maxillary Ridge Opposed by Natural Teeth

the aim of the study to compare the anterior maxillary bone index changes for patient rehabilitated with implant supported fixed prosthesis opposed by natural teeth

Study Overview

• Status: Completed
• Conditions: Prosthesis Survival
• Intervention / Treatment: Procedure: implant supported maxillary fixed prosthesis

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 35111
      • Amr Saeed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. All patient wearing a maxillary implant supported overdenture or implant supported fixed restoration and mandibular natural teeth or fixed restoration within natural dentition.

  2. All patients were unsatisfied by the maxillary restoration and presented clear preference for a better prosthesis.

  3. They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.

  4. At least one year passed after the last restoration. 5. At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna).195 This was detected by a tentative jaw relation.

Exclusion Criteria:

• 1. Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.

  2. Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders which might affect implant lifespan.

  3. Long term immunosuppress and corticosteroid drug therapy. 4. Patient with abnormal habits as clenching and bruxism. 5. Smoking patient. 6. Uncooperative patients. 7. Neuromuscular diseases. 8. Patient with problems in TMJ.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: all on four group; 4 patients received 4-implant supported fixed prosthesis	Procedure: implant supported maxillary fixed prosthesis; Maxillary fixed prosthesis according to all on four or all on six concept
Active Comparator: all on six group; 4 patients received 6-implant supported fixed prosthesis	Procedure: implant supported maxillary fixed prosthesis; Maxillary fixed prosthesis according to all on four or all on six concept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anterior area index	outcome is being evaluated by radiograph	six months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): August 14, 2024
• Study Completion (Actual): August 14, 2024

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Tooth Diseases; Prosthesis Failure; Mouth, Edentulous
• Other Study ID Numbers: M07100522

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No