Plain English Summary
Background and study aims
The treatment of patients without teeth (edentulous) is gaining in importance, because older people make up a growing share of the patient population. To replace lost teeth, implants are increasingly being used in many cases. However, this form of rehabilitation is costly and therefore not affordable for a large part of the population. Complete dentures (false teeth) are still the default form of treatment Each set of dentures shows an occlusal concept, meaning the position of the teeth in the prosthesis and how many contact points appear during function. While different occlusal concepts are available, the ultimate occlusal concept – or an occlusal concept that the patient perceives as satisfactory – has not been conclusively identified.
Over time two occlusal concepts are common. These are the bilateral balanced occlusion and anterior/canine guidance. Studies have highlighted advantages and disadvantages of the respective concepts, but no clear favorite has emerged.
Therefore, this study aims to acquire subjective and objective assessments and to make a recommendation by comparing the two different occlusal concepts.
Who can participate?
Seniors without teeth, using two complete dentures
What does the study involve?
Participants are randomly allocated to one of two groups, and receive two types of complete overdentures. Those in the first group receive one type of dentures first, which are used for three months, then they swap to the second type of dentures.
Those in the second group receive the dentures the other way around.
Participants are assessed at the end of each three month period.
What are the possible benefits and risks of participating?
The participants are able to compare two different concepts regarding the position and the performance of the teeth during function in their prosthesis. With knowledge of both concepts they decide which concept will be their final in their prosthesis.
There are no risks for those taking part in the study.
Where is the study run from?
Goethe University Frankfurt (Germany)
When is the study starting and how long is it expected to run for?
July 2006 to June 2016
Who is funding the study?
1. Goethe University Frankfurt (Germany)
Who is the main contact?
Dr Silvia Brandt (Scientific)
hajjaj@med.uni-frankfurt.de
Trial website
Contact information
Type
Scientific
Primary contact
Dr Silvia Brandt
ORCID ID
Contact details
Theodor-Stern-Kai 7
Frankfurt am Main
60596
Germany
+49 17 782 86781
hajjaj@med.uni-frankfurt.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
00000000
Study information
Scientific title
Randomized Prospective Clinical Study comparing the Bilateral Balanced Occlusion and Anterior/Canine Guidance in Participants wearing Complete Dentures
Acronym
Study hypothesis
The anterior/canine guidance in complete overdentures will be rated better than the bilateral balanced occlusion by participants and dental practitioners.
Ethics approval
Ethics Committee Goethe University Frankfurt Germany, 20/09/2006, ref: 215/06
Study design
Randomized prospective clinical study
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Dentures
Intervention
All participants receive complete overdentures with anterior/canine guidance and the bilateral balanced occlusion using a crossover design. The participants are randomised to one of two groups. Those in group 1 receive anterior/canine guidance dentures first, then crossover to bilateral balanced occlusion. Those in group 2 receive bilateral balanced occlusion dentures first, which are then changed anterior/canine guidance. The crossover occurs after 3 months. At the end of each testing phase, the two occlusal concepts are assessed by practitioners and patients and then analysed using the Wilcoxon-Mann-Whitney and marginal homogeneity tests.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Positional change of maxillary and mandibular denture is measured using clinical examination of two investigators at the end of each testing phase
2. Masticatory efficiency is measured using a numerical rating questionnaire at the end of each testing phase
3. Speech performance is measured using a numerical rating questionnaire at the end of each testing phase
4. Satisfaction is measured using a numerical rating questionnaire at the end of each testing phase
5. Chewing comfort and masticatory efficiency are measured using a numerical rating questionnaire at the end of each testing phase
6. Comfort of the dentures is assessed using a numerical rating questionnaire at the end of each testing phase
Secondary outcome measures
1. Mechanical retention is measured using clinical examination of two investigators at the end of each testing phase
2. Resorption class for maxilla and mandible is assessed using clinical examination of two investigators at the end of each testing phase
Overall trial start date
15/07/2006
Overall trial end date
29/06/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Presence of two functional, aesthetically acceptable complete maxillary and mandibular dentures, not to be more than two years old
2. A bilateral balanced set-up of the denture teeth
3. Good general and mental health
4. Participant compliance
5. Dentures to be worn for the entire six-month study period
6. No scars or grafts in the oral cavity
7. No functional complaints
8. Inconspicuous oral mucosa
9. Sufficient ability to communicate
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Refusal to participate
2. Extended illness
3. Lack of compliance
4. Communication problems
5. Severe physical or mental illness
6. Craniomandibular dysfunction
Recruitment start date
15/07/2007
Recruitment end date
30/04/2014
Locations
Countries of recruitment
Germany
Trial participating centre
Goethe University Frankfurt
Department for Prosthetic Dentistry at the Centre for Dentistry, Oral and Maxillofacial Dentistry
University of Frankfurt am Main
Frankfurt
60596
Germany
Funders
Funder type
University/education
Funder name
Goethe-Universität Frankfurt am Main
Alternative name(s)
Goethe University Frankfurt am Main, Goethe-Universität, Goethe-Universität Frankfurt
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Germany
Results and Publications
Publication and dissemination plan
Planned submission to Gerodontology journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Silvia Brandt (hajjaj@med.uni-frankfurt.de) and Prof. H-Ch. Lauer (h.c.lauer@em.uni-frankfurt.de)
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list