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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 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: December 18, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Anomaly of Dental Arch
Device: Removable partial denture (Chrome Cobalt Distal extension)
Other: A reduced posterior dental arch
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outcomes of Interventions for Patients With a Reduced Posterior Dental Arch: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of the Western Cape:

Primary Outcome Measures:
  • Patient satisfaction [ Time Frame: 3 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


Secondary Outcome Measures:
  • Success of treatment intervention [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Failure of intervention or patient unhappy with treatment prescribed


Other Outcome Measures:
  • Negative outcomes with intervention [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    These include: periodontal breakdown (plaque index, loss of attachment), tooth loss, carious lesion formation, change in treatment or any other self-reported complaints


Estimated Enrollment: 2
Study Start Date: January 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: No intervention for Group B patients

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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597206

Contacts
Contact: Saadika Khan, PhD +27 21 937 3006 skhan@uwc.ac.za

Locations
South Africa
Saadika Khan Recruiting
Cape Town, Western Cape, South Africa, 7800
Contact: Saadika Khan       skhan@uwc.ac.za   
Principal Investigator: Saadika Khan         
Sponsors and Collaborators
University of the Western Cape
Investigators
Principal Investigator: Saadika Khan, PhD Staff Member
  More Information

No publications provided

Responsible Party: Dr Saadika Khan, Dr, University of the Western Cape
ClinicalTrials.gov Identifier: NCT01597206     History of Changes
Other Study ID Numbers: SDA Clinical Trial, SDA South African RCT
Study First Received: May 9, 2012
Last Updated: December 18, 2014
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by University of the Western Cape:
randomized trial
intervention
shortened dental arch
patient satisfaction

Additional relevant MeSH terms:
Tooth Diseases
Tooth Abnormalities
Congenital Abnormalities
Stomatognathic Diseases
Stomatognathic System Abnormalities
Cobalt
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on August 02, 2015