Compressive Single-piece Implants for Immediate Rehabilitation of Edentulous Maxillectomy Patients

NCT ID: NCT06572891

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-07
• Study Completion Date: 2024-07-20

Brief Summary

This within-patient study aimed to compare the satisfaction and oral health-related quality of life (OHRQoL) of edentulous maxillectomy patients with and without immediately loaded implant-supported obturator prostheses using single-piece compressive implants.

Detailed Description

• Inclusion criteria:

• Patients with a status eligible for implants after partial or total maxillectomy or partial or total loss of the maxilla.
• Residual alveolar ridge quantity and quality as verified by cone beam computed tomography (CBCT), especially in the proposed implant sites.
• Exclusion Criteria:

• Patients with systemic diseases that interfere with surgical implant procedures e.g., uncontrolled diabetes or osteoporosis.
• Radiation therapy or chemotherapy to the head and neck area (currently or time interval less than 6 months)
• Patients with local inflammation that may cause interference with implant placement.

All patients were informed about the detailed treatment plan and received a written informed consent to be signed.

II) Preparation of the patient for implant placement:

• Fabrication of maxillary obturator.
• Cone beam computed tomography (CBCT) was performed for all patients to accurately plan implant location, diameter, and angulation.

III) Surgical phase:

• Surgery was performed under local anaesthesia.
• All patients received single-piece compressive implants in the proper positions according to the case demands.
• The patients were prescribed systemic antibiotics for one week, anti-inflammatory, analgesic, and mouthwash.

IV) Prosthetic phase:

• Necks of placed implants bent up to 15 degrees to be parallel placed.
• The maxillary obturator was adjusted on the poured mode, and modified and access holes made above the abutment were finally relined in the patient's mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol.

IV) Evaluation:

• Patient Satisfaction Based on Visual Analog Scale (VAS)
• Oral health impact profile for edentulous patient (OHIP-EDENT)
• Obturator Functioning Scale

Conditions

Patient Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional maxillary obturator

conventional acrylic obturator for each patient

Group Type: ACTIVE_COMPARATOR

Maxillary obturator

Intervention Type: OTHER

conventional acrylic obturator

Implant supported maxillary obturator

Implant-supported maxillary obturator (compressive implants)

Group Type: ACTIVE_COMPARATOR

Implant supported obturator

Intervention Type: OTHER

Implants inserted as planned The necks of the implants were bent up to 15 degrees to be parallel.

• The maxillary obturator was adjusted on the poured mode, modified and access holes will be made above the abutment to be finally relined in the patient mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol.
• Impressions were made

Interventions

Maxillary obturator

conventional acrylic obturator

Intervention Type: OTHER

Implant supported obturator

Implants inserted as planned The necks of the implants were bent up to 15 degrees to be parallel.

• The maxillary obturator was adjusted on the poured mode, modified and access holes will be made above the abutment to be finally relined in the patient mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol.
• Impressions were made

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with a status eligible for implants after partial or total maxillectomy or partial or total loss of the maxilla.
• Residual alveolar ridge quantity and quality will be verified by cone beam computed tomography (CBCT) especially in the proposed implant sites.

Exclusion Criteria

• Patients with systemic diseases that interfere with surgical implant procedures e.g., uncontrolled diabetes or osteoporosis.
• Radiation therapy or chemotherapy to the head and neck area (currently or time interval less than 6-months)
• Patients with local inflammation that may cause interference with implant placement.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of dentistry, mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

M0104023RP

Identifier Type: -

Identifier Source: org_study_id