Interventions for Patients With a Shortened Dental Arch (SDA-RCT)

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

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.

Study Overview

• Status: Completed
• Conditions: Anomaly of Dental Arch
• Intervention / Treatment: Device: Removable partial denture (Chrome Cobalt Distal extension); Other: A reduced posterior dental arch

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7800
      • Saadika Khan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Removable partial denture Group; 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); For Group A: a distal extension removable denture will be constructed for patients with a reduced posterior dental arch; Other Names: Chrome Cobalt Distal extension denture for Group A patients
Active Comparator: Reduced Posterior Dental Arch Group; 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; 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; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative outcomes with intervention	These include: periodontal breakdown (plaque index, loss of attachment), tooth loss, carious lesion formation, change in treatment or any other self-reported complaints	3 months

Collaborators and Investigators

• Sponsor: University of the Western Cape
• Investigators: Principal Investigator: Saadika Khan, PhD, Staff Member

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 10, 2012
• First Posted (Estimate): May 11, 2012

Study Record Updates

• Last Update Posted (Actual): February 13, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: randomized controlled trial; intervention; patient satisfaction; posterior reduced dental arch; sequential sampling
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Cobalt
• Other Study ID Numbers: SDA Clinical Trial; SDA South African RCT (Other Identifier: UWC- SA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: By publishing the results in a reputable (peer reviewed and accredited) journal