Tooth loss/ molar replacement Oral Health Loss of teeth
Conditions
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): Restoratio
Sponsors
German Research Foundation (Deutsche Forschungsgemeinschaft) (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients over 35 years of age, male and female 2. Those 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 3. Rejection of implant treatment by the patient 4. Patients with general health according to American Society of Anesthesiologists (ASA) classification group one ore two 5. 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 6. Caries free adjacent teeth 7. 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
| Measure | Time frame |
|---|---|
| Further tooth loss. Duration of follow-up: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| The following were assessed at baseline (4-8 weeks after insertion), 6 month, then annually from Year 1 to 5: 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), gingival index(index according to Sillnes and Loe: 0-3), bleeding on probing (BOP)(+/-), tooth mobility (index 0-3) , mucosa lesions (California Dental Association [CDA] Criteria) 2. Clinical dysfunction index (Helkimoindex): Muscle pain via palpation (m. masseter pars profunda et superficialis, m. temporalis pars posterior et anterior,m. suboccipitalis, m. sterno-cleidomastoideus, m. pterygoideus medialis et lateralis, t. temporalis) 2.1. Range of movement (mm): maximal opening, maximal lateral movements, maximal protrusion 2.2. TMJ function: Description of pain on movement/path of movement, palpation/auscultation 3. Technical (according to the CDA criteria): Treatment performance, preparation form, marginal fit, occlusion static/dynamic im µm, proximal contacts (shape/ strength) 4. Technical performance (according to the CDA criteria): Evaluation of used materials, prosthesis and bridge design, saddle extension, attachment performance, possibility of dental hygiene 5. Aesthetics (according to the CDA criteria): rated by the dentist, surface, color, translucency, contour 6. Ridge reduction: (x-ray examination according to Steen ) Subjective: 7. Oral health related quality of life (OHIP-Questionnaire): Measure of self reported dysfunction, discomfort and disability attributed to oral conditions 8. Dworkin Index Axis II (questionnaire): Assessment of psychological distress and psychosocial dysfunction including questions regarding: 8.1. Graded chronic pain severity 8.2. Depression 8.3. Vegetative symptoms and somatization subscales of the SCL-90-R developed | — |
Countries
Germany
Outcome results
None listed