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OpenTrials
Completed

NCT Number: NCT01597206

Interventions for Patients With a Shortened Dental Arch

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.

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Key information

Conditions

Anomaly of Dental Arch Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Saadika Khan

Cape Town, Western Cape, 7800, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Removable partial denture (Chrome Cobalt Distal extension)

Device

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

A reduced posterior dental arch

Other

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

Primary outcomes

  1. Patient satisfaction

    Time frame: 3 months

    Two different tools will b used to assess primary outcomes

    • Oral Impact of Daily Performance (OIDP) tool
    • Global Visual Analogue Scale (VAS)

Secondary outcomes

  1. Functioning

    Time frame: 3 months

    Failure of intervention or patient unhappy with treatment prescribed

  2. Oral health-related Quality of Life

    Time frame: 3 months

    A Tool will be used to assess primary outcome

Other outcomes

  1. Negative outcomes with intervention

    Time frame: 3 months

    These include: periodontal breakdown (plaque index, loss of attachment), tooth loss, carious lesion formation, change in treatment or any other self-reported complaints

Sponsors and collaborators

Lead sponsor

University of the Western Cape

Other

Registry information

Official study title

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

Acronym: SDA-RCT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 11, 2012
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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