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

M

Mansoura University

Status

Completed

Conditions

Patient Satisfaction

Treatments

Other: Maxillary obturator
Other: Implant supported obturator

Study type

Interventional

Funder types

Other

Identifiers

NCT06572891
M0104023RP

Details and patient eligibility

About

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.

Full 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

Enrollment

20 patients

Sex

All

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

20 participants in 2 patient groups

Conventional maxillary obturator
Active Comparator group
Description:
conventional acrylic obturator for each patient
Treatment:
Other: Maxillary obturator
Implant supported maxillary obturator
Active Comparator group
Description:
Implant-supported maxillary obturator (compressive implants)
Treatment:
Other: Implant supported obturator

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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