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

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

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.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction
• Intervention / Treatment: Other: Maxillary obturator; Other: Implant supported obturator

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Faculty of Dentistry, Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional maxillary obturator; conventional acrylic obturator for each patient	Other: Maxillary obturator; conventional acrylic obturator
Active Comparator: Implant supported maxillary obturator; Implant-supported maxillary obturator (compressive implants)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	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'	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral health impact profile for edentulous patient (OHIP-EDENT)	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.	6 months
- Obturator Functioning Scale	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'.	6 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2023
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): July 20, 2024

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: VAS; OHIP-EDENT; Obturator Functioning Scale
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: M0104023RP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No