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Completed

NCT Number: NCT06572891

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

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.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, mansoura university

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maxillary obturator

Other

conventional acrylic obturator

Implant supported obturator

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

Primary outcomes

  1. Patient Satisfaction

    Time frame: 6 months

    Patient Satisfaction Based on Visual Analog Scale The patients were asked to rate their overall satisfaction with the dentures on a 100-mm visual analogue scale (VAS) for each type of prosthesis. The anchor of the left end of the VAS was defined as 'completely dissatisfied' and that of the opposite side as 'completely satisfied'

Secondary outcomes

  1. Oral health impact profile for edentulous patient (OHIP-EDENT)

    Time frame: 6 months

    Oral health impact profile for edentulous patients (OHIP-EDENT). The total 19 items are defined to measure seven domains: (1) functional limitation (3 items), (2) pain (4 items), (3) psychological discomfort (2 items), (4) physical disability (3 items), (5) psychological disability (2 items), (6) social disability (3 items), and (7) handicap(2 items). Each item is scored on a Likert scale from 1 ('Never') to 5 ('Very often'). The outcomes of the OHIP-EDENT can have ranged from 19 to 95. A score of 19 means that dental problems do not affect daily life at all, whereas a score of 95 means that dental problems affect daily life very often.

  2. - Obturator Functioning Scale

    Time frame: 6 months

    Obturator functioning scale was assessed in 1-15 questions in terms of no difficulty on a 5-point Likert Scale. Points 1 represent "not at all difficult" and point 2 stood for "a little difficult". Point 1 and 2 were considered as "No Difficulty" on the scale. Points 3, stood for 'somewhat difficult', point 4 for 'very much difficult' and point 5 for 'extremely difficult' and point 3, 4, and 5 were considered as 'Difficulty'.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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