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Randomised multicentre study of prosthetic treatment options for shortened dental arch

Randomised multicentre study of prosthetic treatment options for shortened dental arch

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN97265367
Enrollment
400
Registered
2008-04-04
Start date
2000-10-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth loss/ molar replacement Oral Health Tooth loss/molar replacement

Interventions

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): Restoration

Sponsors

German Research Foundation (Deutsche Forschungsgemeinschaft)
Lead Sponsor
Deutsche Gesellschaft für Prothetische Zahnmedizin und Biomaterialien e.V. (DGPRo)
Collaborator
Deutsche Gesellschaft für Zahn-, Mund- und Kieferheilkunde (DGZMK)
Collaborator
Cendres+Métaux SA
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Further tooth loss is measured at 5, 8, 10 and 15 years

Secondary

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026