Atrophic alveolar ridge that does not allow implant placement Oral Health Atrophy of edentulous alveolar ridge
Conditions
Interventions
Randomization:
The randomization will be done in blocks according to a randomization list generated by a computer using the SPSS program. Treatment allocation will be hidden in sealed, opaque envelope
Sponsors
ThinkingPerio Research - Periocentrum Bilbao
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent after detailed information 2. Adults at least 18 years of age 3. Candidates to receive a bone augmentation for implant placement 4. Presence of a bone defect (=2 teeth) with at least 2 mm of mucosa 5. Keratinized remnant whose bone width is insufficient (<4 mm) measured on a CBCT-type scanner 6. The patient must be periodontally treated at least 1 month before the surgical intervention and in addition to all those oral factors that may affect the treatment
Exclusion criteria
Exclusion criteria: 1. General contraindications for dental/surgical treatment 2. Inflammatory or autoimmune disease of the oral cavity 3. Smokers of more than 10 cigarettes a day 4. Allergy to collagen and analgesics/anti-inflammatory NSAIDs 5. History of cancer in different parts of the body that has required radiotherapy or chemotherapy in the last 5 years 6. Radiation therapy to the head or neck in the last 5 years 7. Current medication with immunosuppressants, bisphosphonates or high doses of corticosteroids 8. Pregnant or nursing women 9. Women of childbearing age who are not using an effective contraceptive method 10. Participating in other biomedical research studies in the 24 weeks prior to the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The horizontal bone gain measured clinically 2 mm from the ridge using a calliper during the first surgical intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The general satisfaction of the patient with the treatment as well as the pre-surgical expectations, measured by the VAS scale calibrated from 1 to 100 points immediately after surgery and at 2, 4, 12, 26, and 52 weeks 2. Horizontal bone gain measured radiographically by CBCT before implant placement (second surgery) 3. Horizontal bone gain measured with a volumetric study using digital impressions (3Shape®) and stone models at baseline, before the second surgery, before the third surgery, and at 1 year, 3 years and 5 years follow-up 4. The peri-implant indices around the implants (bleeding on probing, plaque index, recession of the peri-implant mucosa, probing depth and clinical attachment level and radiographic bone level) measured with a manual periodontal probe during the period of observation up to 52 weeks 5. Time spent in peri-implant bone augmentation treatment measured using a watch during the first surgical procedure 6. Depth of the vestibule in the treatment area measured using digital impressions (3Shape®) at 12, 26 and 52 weeks after the intervention 7. Follow-up of patients and peri-implant health using a manual periodontal probe to measure clinical parameters and periapical x-ray to measure radiographic changes at 3 and 5 years | — |
Countries
Spain
Contacts
Public ContactErik;Alberto Regidor Correa;Ortiz-vigon
;
Outcome results
None listed