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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2012 by University of the Western Cape
Sponsor:
Information provided by (Responsible Party):
Dr Saadika Khan, University of the Western Cape
ClinicalTrials.gov Identifier:
NCT01597206
First received: May 9, 2012
Last updated: May 10, 2012
Last verified: May 2012

May 9, 2012
May 10, 2012
October 2012
March 2014   (final data collection date for primary outcome measure)
Patient satisfaction [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Two different tools will b used to assess primary outcomes

  1. Oral Indicator Dental Profile (OIDP)
  2. Global Visual Analogue Scale
Same as current
Complete list of historical versions of study NCT01597206 on ClinicalTrials.gov Archive Site
Success of treatment intervention [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Failure of intervention or patient unhappy with treatment prescribed
Same as current
Not Provided
Not Provided
 
Interventions for Patients With a Shortened Dental Arch
Outcomes of Interventions for Patients With a Classic Shortened 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 classic Shortened Dental Arch (SDA) will not be satisfied nor improved by replacing the molars with a removable prosthesis.

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 classic SDA will be satisfied and improved without having the molars 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 classic SDA dentition (20 occluding teeth, including all incisors, canines and premolars) 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 (RPD) to replace the molars bilaterally, the other will receive no treatment.

Daily functioning ability and patient satisfaction between the groups (with/without RPD) would then be compared.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anomaly of Dental Arch
  • Device: Removable partial denture (Chrome Cobalt Distal)
    For Group A: a distal extension removable denture will be constructed for patients with a classic SDA
    Other Name: Chrome Cobalt Distal extension denture for Group A patients
  • Other: A classic SDA
    For Group B: Patients with a classic SDA will not be provided with a removable denture and will compared to patients in Group A
    Other Name: No intervention for Group B patients
  • Experimental: Removable partial denture Group
    Patients with a classic SDA will be randomized into one of 2 Groups Group A will receive a removable partial denture
    Intervention: Device: Removable partial denture (Chrome Cobalt Distal)
  • Active Comparator: Shortened Dental Arch Group
    Patients with a Classic SDA and not receiving any Intervention will be compared to the removable partial denture group
    Intervention: Other: A classic SDA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
2
December 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with Classic SDA
  • 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
Both
21 Years to 55 Years
No
Contact: Saadika Khan, PhD +27 21 937 3006 skhan@uwc.ac.za
South Africa
 
NCT01597206
SDA Clinical Trial, SDA South African RCT
No
Dr Saadika Khan, University of the Western Cape
University of the Western Cape
Not Provided
Principal Investigator: Saadika Khan, PhD Staff Member
University of the Western Cape
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP