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Interventions for Patients With a Shortened Dental Arch

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01597206
Acronym
SDA-RCT
Enrollment
50
Registered
2012-05-11
Start date
2014-01-31
Completion date
2016-11-30
Last updated
2017-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anomaly of Dental Arch

Keywords

randomized controlled trial, intervention, posterior reduced dental arch, patient satisfaction, sequential sampling

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.

Interventions

DEVICERemovable 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

OTHERA 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

Sponsors

University of the Western Cape
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient satisfaction3 monthsTwo different tools will b used to assess primary outcomes 1. Oral Impact of Daily Performance (OIDP) tool 2. Global Visual Analogue Scale (VAS)

Secondary

MeasureTime frameDescription
Functioning3 monthsFailure of intervention or patient unhappy with treatment prescribed
Oral health-related Quality of Life3 monthsA Tool will be used to assess primary outcome

Other

MeasureTime frameDescription
Negative outcomes with intervention3 monthsThese include: periodontal breakdown (plaque index, loss of attachment), tooth loss, carious lesion formation, change in treatment or any other self-reported complaints

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026