Clinical trial NCT06572891: Compressive Single-piece Implants for Immediate Rehabilitation of Edentulous Maxillectomy Patients
Official title: Compressive Single-piece Implants for Immediate Rehabilitation of Edentulous Maxillectomy Patients with Compromised Ridge: a Study of Patient Satisfaction and Oral Health Related Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Keywords: VAS
OHIP-EDENT
Obturator Functioning Scale
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 6 months
Secondary outcomes:
measure: Oral health impact profile for edentulous patient (OHIP-EDENT)
timeFrame: 6 months
measure: - Obturator Functioning Scale
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of dentistry, mansoura university
state: Dakahlia
Study officials:
References: