Condition category
Oral Health
Date applied
15/04/2018
Date assigned
25/05/2018
Last edited
25/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Goethe University Frankfurt

Sponsor details

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

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes