Randomised multicentre study of prosthetic treatment options for shortened dental arch
| ISRCTN | ISRCTN97265367 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97265367 |
| Secondary identifying numbers | DFG WA 831/2-1 to 2-6 |
- Submission date
- 26/02/2008
- Registration date
- 04/04/2008
- Last edited
- 29/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Losing teeth is an inevitable part of the aging process for some people. The gaps left by missing teeth can cause problems with eating or speech, as well as affecting appearance, which can be distressing for the sufferer. Losing all of the molars (back teeth used for grinding food) in the upper or lower jaw can be treated in different ways. The main options being replacement with removable dentures (false teeth), dental implants (metal posts which are screwed directly into the jaw bone in order to support replacement teeth) or shortened dental arch (SDA) treatment. SDA is a cost-effective treatment in which only the missing teeth towards the front of the mouth are replaced using fixed bridges (a way of attaching the artificial tooth (or teeth) to a permanent (natural) tooth. There is currently a lack of evidence as to which of these techniques is more beneficial in the long-run. The aim of this study is to compare the effects of SDA and removable partial dentures on future tooth loss and oral health in the long-run.
Who can participate?
Adults over 35 years old who have asked for prosthetic dental treatment who are missing all molars in one jaw and with at least both canines and one premolar left on each side
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given removable partial dentures to replace their missing molars. Those in the second group receive SDA treatment to replace only the essential premolars (teeth between the canines and molars). All participants are examined after 8 weeks, 6 months, 1 year and then every year after the treatment for 5 years. After this, participants have dental exams at 8, 10 and 15 years after treatment. During these examinations dental and oral health are recorded as well as any further tooth loss.
What are the possible benefits and risks of participating?
There is no direct benefit for participants taking part in the study, although participants will receive financial support and compensation for the dental treatments and examinations. There are no risks of taking part other than the general risks associated with having dental surgery.
Where is the study run from?
The study is run from the Departments of Prosthetic Dentistry at the Universities of Berlin, Bonn, Dresden, Freiburg, Giessen, Greifswald, Jena, Kiel, Leipzig, Mainz, Munich, Wuerzburg, Witten and Homburg.
When is the study starting and how long is it expected to run for?
October 2000 to December 2022
Who is funding the study?
German Research Foundation (Germany)
Who is the main contact?
Professor Michael Walter
Michael.Walter@uniklinikum-dresden.de
Contact information
Scientific
Fetscherstr. 74
Dresden
01307
Germany
| Phone | +49 351/458 2706 |
|---|---|
| Michael.Walter@uniklinikum-dresden.de |
Study information
| Study design | Multi-centre randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled 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 | Randomised multicentre study of prosthetic treatment options for shortened dental arch |
| Study acronym | SDAS |
| Study hypothesis | Over the last 20 years a mechanistic attitude correlated with a lack of longitudinal controlled randomised trials regarding the question of prosthetic treatment after tooth loss. The need assessment considered the replacement of all missing teeth by fixed or removable partial dentures or dental implants as a necessity especially in cases of shortened dental arches. Modern prosthetic concepts distinguish between different dimensions of need (normative need, perceived need) being well aware of the fact that perceived need has been under-represented in the past. An innovative sight puts a higher emphasis to the subjective components of need assessment and outcome measurement. Generally three adverse effects of non-replacement of molars were postulated: temporomandibular joint (TMJ) disorders, tooth migration/overeruption, insufficient chewing ability. However, no evidence based on randomised trials has been provided concerning the incidence of the adverse side effects mentioned above, nor is there high-level evidence regarding a benefit of removable dentures for molar replacement. On the contrary removable partial dentures are compromised by a high incidence of adverse side effects such as plaque accumulation and peridontal breakdown. Among therapeutic alternatives, an approach with a limited restoration goal focused on incisors, canines and premolars (shortened dental arch [SDA] concept) has been described and implemented although discussed controversially. Within this concept, fixed partial dentures are used for tooth replacement of which a superior performance compared with removable partial dentures has been reported. The multi-centre study was initiated in 2000 because evidence was lacking concerning the benefit of different therapeutic options regarding the preservation of oral health, oral health related quality of life, patients satisfaction, absence of discomfort, satisfactory chewing ability and aesthetic satisfaction. Public health aspects of the study lie in the fields of health economics, avoidance of over-treatment, and therapy guidelines on a population based level. Two prosthetic therapy arms will be compared: 1. The replacement of posterior teeth at last up to the first molar by removable partial dentures 2. Prosthetic treatment according to the shortened dental arch concept. To avoid removable partial dentures, posterior teeth are replaced up to the second premolar by fixed restorations, if necessary. Molars are not replaced. The aim of this trial is to test the hypothesis that the treatment outcome varies depending on the treatment concept (fixed versus removable prostheses) in the therapy of patients with missing molars. |
| Ethics approval(s) | Ethics Committee of the Medical Faculty of the Technical University of Dresden (Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden). Date of approval: 19/04/1999 (ref: EK 260399) |
| Condition | Tooth loss/ molar replacement |
| Intervention | Control group (Therapy A): The molar replacement by removable partial dentures, carried out using fixed crowns and bridges as anchor for removable dentures Intervention group (Therapy B): Restorations according to the SDA concept, with only fixed restorations or no restoration at all. The maximum extension reached up to the second premolar, and no molars were replaced. All restorations were made according to a standardized procedure (SOP) given by the study protocol. Standard gold alloys and dental ceramics were used for fixed restorations, base metal alloys for the removable denture frameworks. |
| Intervention type | Other |
| Primary outcome measure | Further tooth loss is measured at 5, 8, 10 and 15 years |
| Secondary outcome measures | The following will be assessed at baseline (4-8 weeks after insertion), 6 month, then annually from Year 1 to 5, and further at 8, 10 and 15 years: 1. Clinical: 1.1. Crown/root caries 1.2. Abrasion (Index 0-4) 1.3. Interdental spacing in the anterior region (Index 0-3) 1.4. Sensibility (+/-) 1.5. Periodontitis/Gingivitis: Plaque-index (index 0-3), probing depth (6 point measurement in mm), attachment loss (6 point measurement in mm), bleeding on probing (BOP)(+/-), tooth mobility (index 0-3), mucosa lesions (California Dental Association [CDA] Criteria) 2. Clinical dysfunction index: Muscle pain via palpation (m. masseter pars profunda et superficialis, m. temporalis pars posterior et anterior, m. pterygoideus medialis et lateralis) 3. Range of movement (mm): maximal opening 4. TMJ function: Description of pain on movement/path of movement, palpation/auscultation 5. Technical (according to the CDA criteria): Treatment performance, preparation form, marginal fit, occlusion static/dynamic in µm, proximal contacts (shape/ strength) 6. Technical performance (according to the CDA criteria): Evaluation of used materials, prosthesis and bridge design, saddle extension, possibility of dental hygiene Subjective: 9. Oral health related quality of life (OHIP-Questionnaire): Measure of self reported dysfunction, discomfort and disability attributed to oral conditions 10. Dworkin Index Axis II (questionnaire): Assessment of psychological distress and psychosocial dysfunction including questions regarding: 10.1. Graded chronic pain severity 10.2. Depression 10.3. Vegetative symptoms and somatization subscales of the SCL-90-R developed by Derogatis and others 10.4. Jaw disability checklist The CDA Criteria are used according to the Guidelines for the Assessment of Clinical Quality and Professional Performance of the California Dental Association: http://www.cda.org/library/cda_member/policy/quality/quality.html |
| Overall study start date | 01/10/2000 |
| Overall study end date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Participant inclusion criteria | 1. Patients over 35 years of age, who requested prosthetic treatment with a minimum dentition of both canines and one premolar per side preserved in at least one jaw (Kennedy class I). A dentition including all anterior teeth up to the second premolar on both sides in one jaw was defined as maximum 2. Rejection of implant treatment by the patient 3. Patients with general health according to American Society of Anesthesiologists (ASA) classification group one ore two 4. All abutment teeth must be free of periodontal disease (pocket depth less or equal 4 mm, tooth mobility <= grade 2, mean plaque index <= grade 2, bleeding on probing at all teeth <=25 %) and caries 5. Caries free adjacent teeth 6. Sufficient treatment of the opposite jaw, extending the dentition depending on the randomized treatment option up to the second premolar or the first molar |
| Participant exclusion criteria | 1. Patients with alcohol or drug addiction 2. Mentally disordered patients 3. Patients with TMJ disorders 4. Dysgnathic patients with Angle class II or III 5. Patients who have received or need orthodontical treatment 6. Patients who have been already sufficiently treated 7. Patients who do not accept a removable deture 8. Patients who demand the replacement of all molars 9. Patients with general health American Society of Anesthesiologists (ASA) classification group four |
| Recruitment start date | 01/10/2000 |
| Recruitment end date | 31/12/2010 |
Locations
Countries of recruitment
- Germany
Study participating centres
Technische Universität Dresden
Dental School
Fetscherstraße 74
Dresden
01307
Germany
Center for Dental and Craniofacial Sciences
Department of Prosthodontics
Geriatic Dentistry and Craniomandibular Disorders
Campus Benjamin Franklin
Aßmannshauser Straße 4
Berlin
14197
Germany
Preclinical Education and Dental Materials Science
Welschnonnenstr.17
Bonn
53111
Germany
Hugstetter Str.55
Freiburg
79106
Germany
Schlangenzahl 14
Gießen
35392
Germany
Dental School
Rotgerberstr. 8
Greifswald
17487
Germany
An der alten Post 4
Jena
07740
Germany
Arnold-Heller-Str. 16
Kiel
24105
Germany
Nürnberger Str. 57
Leipzig
04103
Germany
Augustusplatz 2
Mainz
55131
Germany
Goethestr. 70
Munich
80336
Germany
Pleicherwall 2
Würzburg
97070
Germany
Alfred-Herrhausen-Str. 50
Witten
58448
Germany
Geb. 71N
Homburg
66421
Germany
Sponsor information
Government
Kennedyallee 40
Sponsorship valid until 2010
Bonn
53175
Germany
| Phone | +49 228/885 1 |
|---|---|
| postmaster@dfg.de | |
| Website | http://www.dfg.de |
Other
Geschäftsstelle
Zahnklinik der Sozialstiftung Bamberg
Buger Straße 82
Bamberg
96049
Germany
| Phone | +49 951 700 362 60 |
|---|---|
| info@dgpro.de | |
| Website | https://www.dgpro.de |
Other
Liesegangstr. 17 a
Düsseldorf
40211
Germany
| Phone | + 49 2 11 / 61 01 98 0 |
|---|---|
| dgzmk@dgzmk.de | |
| Website | http://www.dgzmk.de |
Industry
Rue de Boujean 122
Biel/Bienne
CH-2501
Switzerland
| Phone | +41 58 360 20 00 |
|---|---|
| info@cmsa.ch | |
| Website | http://www.cmsa.ch |
Not defined
| Website | http://www.dfg.de/en/ |
|---|---|
"ROR" |
https://ror.org/018mejw64 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2010 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in peer reviewed journals. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/02/2010 | Yes | No | |
| Results article | results | 01/08/2010 | Yes | No | |
| Results article | results | 01/07/2012 | Yes | No | |
| Results article | results | 01/03/2014 | Yes | No | |
| Results article | results | 01/07/2014 | Yes | No | |
| Results article | results | 01/07/2014 | Yes | No | |
| Results article | results | 01/12/2014 | Yes | No |
Editorial Notes
29/01/2016: Publication reference and plain English summary added.
28/01/2016: The overall trial end date has been extended from 31/12/2010 to 31/12/2022. As a result of this, the primary and secondary outcome measures will also be measured at 8, 10 and 15 years (in addition to the original timepoint of 5 years). All participating trial participating centres have now been included on the record. Additionally, the sponsors DGPRo, DGZMK and Cendres+Metaux have been added, providing sponsorship since 2010.
