Mandibular and maxillary alveolar bone atrophies requiring bone augmentation Musculoskeletal Diseases
Conditions
Interventions
Implant placement (T0):
Before the surgical procedure, hydrocolloid impressions are taken and poured with dental stone. A surgical guide implemented with a diagnostic wax-up of the crown to be replace
Sponsors
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and non-pregnant/lactating female patients aged 18 years or older 2. Presence of mono-edentulism or partial edentulism up to two adjacent teeth located in the upper or in the lower jaw 3. Residual horizontal ridge thickness <6 mm requiring bone augmentation 4. Primary stability of the placed implant 5. Loss/extraction of teeth occurred at least 2 months before the date of the supposed GBR, with healed soft tissues at the implant site 6. American Society of Anaesthesiologists (ASA) physical status classification 1 or 2
Exclusion criteria
Exclusion criteria: 1. Presenting with full mouth plaque and bleeding scores =25% 2. Smoking habits (>10 cigarettes/day) 3. Uncontrolled diabetes 4. In therapy with antiresorptive agents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Horizontal bone gain assessed clinically by means of two intraoperative measurements: during the GBR surgery (T0) and subsequently at the implant uncovering (T1) after 6 months of healing. The measurements of the entire buccal-lingual/palatal ridge thickness is performed with a Castroviejo surgical caliper 2 mm apically from the top of the crest and rounded to the nearest mm at the centre of the implant site. The remaining teeth adjacent to the defect and the surgical guide are used as reference points, in order to repeat the exact mesio-distal measurement position during the second examinations at T1. Furthermore, at T1 the BBT is measured with a periodontal probe (PCP-UNC 15, Hu-Friedy, Chicago, Illinois, USA) rounded to the nearest 0.5 mm at the centre of the implant site. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The clinical evaluation of the biocompatibility of the CM is performed throughout the healing period from T0 to T1. During the 6-month healing period, the complication rate is assessed to evaluate the biocompatibility of the CM in relation to the post-operative complications, namely flap dehiscences, membrane exposures, presence of infections and fistulae with pus discharge amongst others. At T1, the macroscopic appearance of the reconstructed site is assessed intra-surgically to evaluate graft integration and detect any remnants of the CM or its complete resorption due to the degradation phases. 2. With respect to patient-reported outcome measures (PROMs), the evaluation of the postoperative morbidity is carried out by means of a specific form. Indeed, a questionnaire about the postoperative course from 5 to 6 h postoperatively (before intake of the prescribed analgesics) and until the third postoperative day is filled by the patients. A 100-mm visual analogue scales (VAS) with extreme endpoints is used to record the following: 2.1. The intensity of postoperative pain on the day of surgery, 1, 2 and 3 days after surgery (no and extreme pain) 2.2. The severity of swelling on the day of surgery, 1, 2 and 3 days after surgery (no and severe swelling) 2.3. The severity of bleeding from the wound on the day of surgery, 1, 2 and 3 days after surgery (no and severe bleeding) Furthermore, on the day of the surgery, the patients scored their satisfaction with their perception of the operation (not and very unpleasant). The questionnaires are collected at the time of the first postoperative recall 7 days after T0. By means of a ruler, the VAS scores are measured and rounded off to the nearest mm. 3. For the evaluation of the mesial and distal marginal bone loss, intraoral digital radiographs are taken using the long-cone paralleling technique with the central beam directed to the alveolar crest. Periapical radiographs are taken at the delivery of the prosthesis and after | — |
Countries
Italy
Contacts
Public ContactLuca Giboli
Outcome results
None listed