| Methods |
Design: three group parallel trial
Purpose: evaluate the efficacy of bone induction for the placement of dental implants using recombinant human bone morphogenetic protein‐2. |
| Participants |
Patients: patients requiring local alveolar ridge preservation/augmentation of buccal wall defects following extraction of maxillary teeth.
Baseline comparability: NS |
| Interventions |
Placebo: bioabsorbable collagen sponge (ACS) alone
Untreated: No‐treatment
Experimental: recombinant human bone morphogenetic protein‐2 delivered on a ACS.
(Co‐intervention: preoperative antibiotics and 0.12% chlohexidine rinse (15ml)) |
| Outcomes |
Alveolar bone height and bone width (CT scan)
Alveolar bone volume (CT scan)
Bone density (CT scan)
Bone biopsy |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'Two sequential cohorts of 40 patients each were randomized in a double‐masked manner...' |
| Blinding?
Outcome assessor |
Low risk |
'... three independent masked CT scan reviewers...' |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| Trial size > 49? |
High risk |
N = 37 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
