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Patient Satisfaction and Adaptation of Dentures Printed at 0 Versus 45 Degrees

NCT ID: NCT06164366

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-12-31

Brief Summary

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This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of 0 degrees versus 45 degrees.

Detailed Description

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This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of zero degrees versus forty five degrees. Since there is no sufficient evidence surrounding the topic at hand, a randomized clinical trial must be conducted in an attempt to gap the clinical knowledge regarding printing orientation and its effect on denture base adaptation and patient satisfaction. The main question and the one that needs further investigations as stated by Goodacre would these differences in these build up angles have a true clinical effect on denture adaptation and denture retention

Conditions

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Edentulous Jaw

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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0 Degrees Group

dentures will be printed at a 0 degrees build angle

Group Type EXPERIMENTAL

0 degrees 3D printed upper complete dentures

Intervention Type DEVICE

3d printed dentures at a build angle of 0 degrees

45 Degrees Group

dentures will be printed at a 45 degrees build angle

Group Type ACTIVE_COMPARATOR

45 degrees 3D printed upper complete dentures

Intervention Type DEVICE

3d printed dentures at a build angle of 45 degrees

Interventions

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0 degrees 3D printed upper complete dentures

3d printed dentures at a build angle of 0 degrees

Intervention Type DEVICE

45 degrees 3D printed upper complete dentures

3d printed dentures at a build angle of 45 degrees

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients above the age of 40
2. Patients with opposing full natural dentition or completely or partially edentulous arches
3. Opposing arch should be either having a set of full natural dentition or is restored by fixed partial dentures or implants
4. Cooperative patients that are willing to attend all follow-up periods.
5. Patients with healthy attached mucosa of appropriate thickness free from any inflammation.

6- Patients free from any systemic disease that might affect the health of the bone or of the mucosa eg diabetes

Exclusion Criteria

1. Patients with any temporomandibular joint disorder or parafunctional habits
2. Patients with flabby or flat ridges
3. Patients with extreme anatomical limitations such as a large torus that requires surgical excision.
4. Patients with a history of allergy to dentures made of resins.
5. Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
6. Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Iman Abd-ElWahab Radi, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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245326677

Identifier Type: -

Identifier Source: org_study_id