Interventions for Patients With a Shortened Dental Arch

Study Overview
=================
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.

Detailed Description
-----------------
The aim of this research is to determine whether the daily functional needs and the quality of life of partially dentate adult patients with a reduced posterior dental arch will be satisfied and improved without having the posterior teeth replaced with a removable prosthesis, as compared to having the use of such prosthesis. Objectives: To conduct a randomized controlled trial amongst partially dentate adult patients with a reduced posterior dental arch (3-5 pairs of posterior occluding pairs of teeth) and where these patients will be randomly assigned to one of two groups: one group would be provided with a metal- based removable partial denture (RPDP) to replace the posterior teeth, the other will receive no treatment. Daily functioning ability and patient satisfaction between the groups (with/without RPDP) would then be compared.

Official Title
-----------------
Outcomes of Interventions for Patients With a Reduced Posterior Dental Arch: A Randomized Controlled Trial

Conditions
-----------------
Anomaly of Dental Arch

Intervention / Treatment
-----------------
* Device: Removable partial denture (Chrome Cobalt Distal extension)
* Other: A reduced posterior dental arch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Removable partial denture Group<br>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)<br>* For Group A: a distal extension removable denture will be constructed for patients with a reduced posterior dental arch<br>* Other names: Chrome Cobalt Distal extension denture for Group A patients;|
| Active Comparator: Reduced Posterior Dental Arch Group<br>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<br>* 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<br>* Other names: No intervention for Group B patients;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Two different tools will b used to assess primary outcomes Oral Impact of Daily Performance (OIDP) tool Global Visual Analogue Scale (VAS) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functioning | Failure of intervention or patient unhappy with treatment prescribed | 3 months | 
| Oral health-related Quality of Life | A Tool will be used to assess primary outcome | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
randomized controlled trial, intervention, posterior reduced dental arch, patient satisfaction, sequential sampling