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

• Sponsor: Mansoura University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06114069
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Prosthesis Survival	Procedure: implant supported maxillary fixed prosthesis	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The patients were classified into 2 groups: Group I; 4 patients received 4-implant supported fixed prosthesis. Group II; 4 patients received 6-implant supported fixed prosthesis.The patients were classified into 2 groups:Group I; 4 patients received 4-implant supported fixed prosthesis. Group II; 4 patients received 6-implant supported fixed prosthesis.
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Prosthetic Management of All on Four Versus All on Six to Rehabilitate Completely Edentulous Maxillary Ridge Opposed by Natural Teeth
• Actual Study Start Date: May 10, 2022
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. anterior area index [six months]

   outcome is being evaluated by radiograph

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

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

2. 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.

3. 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.

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

2. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amr Saeed	Mansoura	DK	Egypt	35111

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amr ELsaeed, researcher, Mansoura University
• ClinicalTrials.gov Identifier: NCT06114069
• Other Study ID Numbers: M07100522
• First Posted: Nov 2, 2023
• Last Update Posted: Nov 2, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mouth, Edentulous; Prosthesis Failure

Study Results

No Results Posted as of Nov 2, 2023