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

Not Applicable

Completed

• Conditions: Patient Satisfaction
• Interventions: Other: Maxillary obturator; Other: Implant supported obturator

• Registration Number: NCT06572891
• Lead Sponsor: Mansoura University

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

Study Timeline

• Status Verified: 2023-04
• Study Start: 2023-05-07
• Primary Completion: 2024-06-20
• Study Completion: 2024-07-20
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-23
• Last Update Submitted: 2024-08-23
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional maxillary obturator	Maxillary obturator	conventional acrylic obturator for each patient
Implant supported maxillary obturator	Implant supported obturator	Implant-supported maxillary obturator (compressive implants)

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	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 Outcome Measures

Name	Time	Method
Oral health impact profile for edentulous patient (OHIP-EDENT)	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.
- Obturator Functioning Scale	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'.

Trial Locations

Locations (1)

Faculty of dentistry, mansoura university; 🇪🇬 Mansoura, Dakahlia, Egypt