Patient perception and clinical effectiveness of an allogeneic cortical sheet versus an autologous laminated bone graft for the treatment of horizontal bone defects

Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: 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 envelopes until the time of surgery. In this study, neither the patient nor the operator nor the examiner can be blinded. The statistician will be blinded. On day 0 the first surgical procedure will be performed, which will include the following phases: 1. Pre‐surgical measurement of the width of the buccal mucosa with a probe millimeter CP15 and impression of the area to be treated 2. Pre‐surgical and post‐surgical periapical x‐ray of the area to be intervened 3. The stopwatch is activated to measure the intervention time 4. Local anesthesia and elevation of a full‐thickness flap to expose the area bone that will receive the bone graft 5. Measurement of the width of the alveolar process using a millimeter gauge 2 mm apically to the alveolar ridge in each of the positions to receive an implant 6. The flap is released by cutting the deep periosteum and a superficial release of the flap muscle attachments 7. Randomization of the type of graft to receive: bone allograft sheet (LifeNet Health OraGRAFT Cortical Plate®) versus autologous bone graft sheet. In case of receiving an autologous bone graft, the posterior retromandibular area (oblique line) will be anesthetized and a graft will be taken that has the length and width of the treated area between 1 and 2 mm in diameter thickness (Barbieri et al. 2017) CONDITION: Atrophic alveolar ridge that does not allow implant placement ; Oral Health ; Atrophy of edentulous alveolar ridge PRIMARY OUTCOME: The horizontal bone gain measured clinically 2 mm from the ridge using a calliper during the first surgical intervention SECONDARY OUTCOME: ; 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; 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
Epistemonikos ID: 0b91aac0fa2af284c56144b000f520b9511f3743
First added on: Aug 24, 2024