Treatment Outcomes After Receiving Conventional Clasp or Precision Attachment Removable Partial Dentures.

NCT ID: NCT02924142

Last Updated: 2016-10-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-11-30

Brief Summary

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PICOTS:

P: Kennedy class І patients

I : Mandibular removable partial denture with OT Cap attachment

C: Mandibular removable partial denture with gingival approaching clasp assembly

O: 1ry outcome: Oral Health Related Quality of Life

2ry outcome: Biting force

T: 1 Year

S : Randomized control trial

Research question:

In Kennedy class І patients will the removable partial denture with OT Cap attachment compared to conventional removable partial denture with clasp assembly results in difference in Oral Health Related Quality of Life of Patients?

Detailed Description

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In bilateral edentulous mandible with missing molars, the clasp retained partial denture will be compared with precision attachment partial denture for better quality of life for patients.

Conditions

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Bilateral Edentulous Mandible (Kennedy Class I)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention

Mandibular removable partial denture with OT Cap attachment

Group Type EXPERIMENTAL

OT Cap attachment

Intervention Type DEVICE

The RHEIN 83 OT CAP attachment system is an extra-coronal castable attachment positioned on the distal of the abutment crowns as an extension allowing a lot of vertical space for optimal esthetics.

Comparator

Mandibular removable partial denture with gingival approaching clasp assembly

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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OT Cap attachment

The RHEIN 83 OT CAP attachment system is an extra-coronal castable attachment positioned on the distal of the abutment crowns as an extension allowing a lot of vertical space for optimal esthetics.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients with mandibular free end saddle cases.
2. Patients less than 75 years old.
3. Patients who approved to be included in the trial and signed the informed consent.
4. Patients are not suffering from diabetes mellitus.

Exclusion Criteria

1. Patients are suffering from diabetes mellitus.
2. Patients above 75 years old.
3. Patients are receiving chemotherapy or radiotherapy.
4. Patients with severe Temporomandibular Joint problems.
5. Patients who refused the trial.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 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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Rania Hassan

Dentist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yousr M. Mady, Professor

Role: STUDY_DIRECTOR

Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt

Ahmed M. Fayyad, A. Professor

Role: STUDY_DIRECTOR

Faculty of Oral and Dental Medicine, Cairo University, Cairo, Egypt

Locations

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Faculty of Oral and Dental Medicine, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Rania M. Hassan, MSC

Role: CONTACT

(+02) 010 018 05207 ext. (+02) 24041357

Facility Contacts

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Yousr M. Mady, Professor

Role: primary

(+02)01006453846

Other Identifiers

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CEBD-CU-2016-09-212

Identifier Type: -

Identifier Source: org_study_id

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