Interventions for Patients With a Shortened Dental Arch

Phase 1

Completed

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

• Registration Number: NCT01597206
• Lead Sponsor: University of the Western Cape

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.

Study Timeline

• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-11
• Study Start: 2014-01
• Status Verified: 2016-01
• Primary Completion: 2016-10
• Study Completion: 2016-11
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Removable partial denture Group	Removable partial denture (Chrome Cobalt Distal extension)	Patients with a reduced posterior dental arch will be randomized into one of 2 Groups Group A will receive a removable partial denture prosthesis
Reduced Posterior Dental Arch Group	A reduced posterior dental arch	Patients with a reduced posterior dental arch and not receiving any Intervention will be compared to the removable partial denture group

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	3 months	Two different tools will b used to assess primary outcomes; 1. Oral Impact of Daily Performance (OIDP) tool; 2. Global Visual Analogue Scale (VAS)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Saadika Khan; 🇿🇦 Cape Town, Western Cape, South Africa