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

NCT06114069 | Completed

• 1 other identifier: M07100522
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prosthesis Survival

Outcome Measures

Primary Outcomes (1)

• anterior area index

  outcome is being evaluated by radiograph

  six months

Study Arms (2)

all on four group

ACTIVE COMPARATOR

4 patients received 4-implant supported fixed prosthesis

Procedure: implant supported maxillary fixed prosthesis

all on six group

ACTIVE COMPARATOR

4 patients received 6-implant supported fixed prosthesis

Procedure: implant supported maxillary fixed prosthesis

Interventions

implant supported maxillary fixed prosthesis PROCEDURE

Maxillary fixed prosthesis according to all on four or all on six concept

all on four group; all on six group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. All patient wearing a maxillary implant supported overdenture or implant supported fixed restoration and mandibular natural teeth or fixed restoration within natural dentition.
• \. All patients were unsatisfied by the maxillary restoration and presented clear preference for a better prosthesis.
• \. 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.
• \. 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.

You may not qualify if:

• \. Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
• \. Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders which might affect implant lifespan.
• \. 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Amr Saeed

Al Mansurah, DK, 35111, Egypt

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Model Details: The patients were classified into 2 groups: 1. Group I; 4 patients received 4-implant supported fixed prosthesis. 2. Group II; 4 patients received 6-implant supported fixed prosthesis.

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 2, 2023
• Study Start: May 10, 2022
• Primary Completion: August 14, 2024
• Study Completion: August 14, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-08

Locations

EG (1)