The comparison of two different full denture concepts

ISRCTN	ISRCTN13728393
DOI	https://doi.org/10.1186/ISRCTN13728393
Secondary identifying numbers	00000000

Submission date: 15/04/2018
Registration date: 25/05/2018
Last edited: 25/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Silvia Brandt
Scientific

Theodor-Stern-Kai 7
Frankfurt am Main
60596
Germany

Phone	+49 17 782 86781
Email	hajjaj@med.uni-frankfurt.de

Study information

Study design	Randomized prospective clinical study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomized Prospective Clinical Study comparing the Bilateral Balanced Occlusion and Anterior/Canine Guidance in Participants wearing Complete Dentures
Study objectives	The anterior/canine guidance in complete overdentures will be rated better than the bilateral balanced occlusion by participants and dental practitioners.
Ethics approval(s)	Ethics Committee Goethe University Frankfurt Germany, 20/09/2006, ref: 215/06
Health condition(s) or problem(s) studied	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
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 study start date	15/07/2006
Completion date	29/06/2016

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	50
Key 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
Key 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
Date of first enrolment	15/07/2007
Date of final enrolment	30/04/2014

Locations

Countries of recruitment

Germany

Study 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

Sponsor information

Goethe University Frankfurt
University/education

ZZMK (Carolinum)
Department for Prosthetic Dentistry
Theodor-stern-Kai 7
Frankfurt am Main
60596
Germany

"ROR"	https://ror.org/04cvxnb49

Funders

Funder type

University/education

Goethe-Universität Frankfurt am Main
Government organisation / Local government

Alternative name(s): Goethe University Frankfurt am Main, Goethe-Universität, Goethe-Universität Frankfurt
Location: Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned submission to Gerodontology journal.
IPD sharing plan	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)