Clinical trial NCT01597206: Interventions for Patients With a Shortened Dental Arch
Official title: Outcomes of Interventions for Patients With a Reduced Posterior Dental Arch: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anomaly of Dental Arch
Keywords: randomized controlled trial
intervention
posterior reduced dental arch
patient satisfaction
sequential sampling
Lead sponsor: University of the Western Cape
Sponsor class: OTHER
First posted: 2012-05-11
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Patient satisfaction
timeFrame: 3 months
Secondary outcomes:
measure: Functioning
timeFrame: 3 months
measure: Oral health-related Quality of Life
timeFrame: 3 months
Other outcomes:
measure: Negative outcomes with intervention
timeFrame: 3 months
Locations:
city: Cape Town
country: South Africa
facility: Saadika Khan
state: Western Cape
Study officials:
affiliation: Staff Member
name: Saadika Khan, PhD
role: PRINCIPAL_INVESTIGATOR
References: