NCT01597206

Brief Summary

Dental services for large sectors of the population of the Western Cape (WC) Province of South Africa (SA) has been, and continues to be, limited to low-cost treatment options and emergency services, such as extractions at public health clinics. Replacement of missing teeth for the disadvantaged majority of the population is provided almost exclusively at the dental teaching institutions. Loss of teeth in the WC Province is, as elsewhere, the result of disease and the lack of restorative care and then having these replaced by a removable partial denture, if the patient can afford it Null Hypothesis: The daily functional needs and quality of life of partially dentate adult patients with a reduced posterior dental arch and /or a Shortened Dental Arch (SDA) will not be satisfied nor improved by replacing the posterior teeth with a removable prosthesis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2012

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 13, 2017

Status Verified

January 1, 2016

Enrollment Period

2.8 years

First QC Date

May 9, 2012

Last Update Submit

February 9, 2017

Conditions

Anomaly of Dental Arch

Keywords

randomized controlled trialinterventionposterior reduced dental archpatient satisfactionsequential sampling

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    Two different tools will b used to assess primary outcomes 1. Oral Impact of Daily Performance (OIDP) tool 2. Global Visual Analogue Scale (VAS)

    3 months

Secondary Outcomes (2)

  • Functioning

    3 months

  • Oral health-related Quality of Life

    3 months

Other Outcomes (1)

  • Negative outcomes with intervention

    3 months

Study Arms (2)

Removable partial denture Group

EXPERIMENTAL

Patients with a reduced posterior dental arch will be randomized into one of 2 Groups Group A will receive a removable partial denture prosthesis

Device: Removable partial denture (Chrome Cobalt Distal extension)

Reduced Posterior Dental Arch Group

ACTIVE COMPARATOR

Patients with a reduced posterior dental arch and not receiving any Intervention will be compared to the removable partial denture group

Other: A reduced posterior dental arch

Interventions

Removable partial denture (Chrome Cobalt Distal extension)DEVICE

For Group A: a distal extension removable denture will be constructed for patients with a reduced posterior dental arch

Also known as: Chrome Cobalt Distal extension denture for Group A patients
Removable partial denture Group
A reduced posterior dental archOTHER

For Group B: Patients with a reduced posterior dental arch will not be provided with a removable denture and will be compared to patients in Group A

Also known as: No intervention for Group B patients
Reduced Posterior Dental Arch Group

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with Classic SDA
  • Patients with a reduced posterior dental arch (from 3-5 posterior occluding teeth)
  • Specific Age limits
  • Remaining teeth periodontally sound
  • Lost molars in one jaw
  • Both canines and one premolar should be present

You may not qualify if:

  • Exclude patients with Angle Class 2 or 3
  • Signs of Temporo-mandibular disorders
  • Compliance is a problem (Alcoholism/ drug addiction)
  • Risk of over-eruption of teeth
  • Patients wanting removable partial dentures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saadika Khan

Cape Town, Western Cape, 7800, South Africa

Location

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Denture, Partial, Removable

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Denture, PartialDenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Officials

  • Saadika Khan, PhD

    Staff Member

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 11, 2012

Study Start

January 1, 2014

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

February 13, 2017

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will share

By publishing the results in a reputable (peer reviewed and accredited) journal

Locations

ZA(1)