Lindeboom 2006.
| Methods | Trial design: randomised, parallel group trial Location: Amsterdam, the Netherlands Number of centres: one (Oral and Maxillofacial Surgery Department of the Academic Medical Center of the University of Amsterdam, The Netherlands) Recruitment period: not stated Funding source: not stated |
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| Participants | Inclusion criteria: healthy (ASA I) patients missing single teeth in anterior maxilla (premolar to premolar), allowing the placement with no fenestration of a at least 8 mm long implant with a diameter of 3.4 mm placed with an insertion torque of at least 30 Ncm Exclusion criteria: patients with smoking habits, parafunctional habits, drug or alcohol abuse, lack of a stable occlusion, lack of adequate proper oral hygiene and compliance and any systemic diseases likely to compromise implant surgery Age at baseline: 42.3 years ± 13.1 (range 19‐78) Gender: M17/F31 Number randomised: 48 Number evaluated: 48 |
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| Interventions |
Comparison: Occlusal versus non‐occlusal immediate loading Gp A (n = 24) Immediate loading occlusal: Single implants immediately restored within 1 day with acrylic single crowns in occlusion Gp B (n = 24) Immediate loading non occlusal: Single implants immediately restored within 1 day with acrylic single crowns not in occlusion Permanent ceramic crowns were provided to both groups after 6 months BioComp® (BioComp Industries BV, Vught, The Netherlands) tapered TPS screws were used Duration of follow‐up :1 year |
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| Outcomes | Prosthesis/implant failures, Osstell, marginal bone level changes on intraoral radiographs, Papilla Index by Jemt 1997 and midbuccal gingival levels 1‐year data used |
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| Notes | Sample size calculation:Not reported, but authors note that small sample size in this study was the reason that "no definite conclusions could be drawn" | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Reported in the article: "Patients were allocated to either immediate loading or immediate provisionalization groups by means of computer generated randomization" |
| Allocation concealment (selection bias) | Low risk | Nothing reported in the article Author replied that "The treatment allocation (after computer randomization) was presented at placement of the provisional. so that the patient was treated with an implant, and after that was moved to the next room with an impression post for provisional fabrication. At that point a call was received from the Clinical Epidemiology Unit (performing randomization)" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Nothing reported in the article Author replied that "outcome assessors were blinded" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All data presented |
| Selective reporting (reporting bias) | Low risk | All outcomes appear to be presented |
| Other bias | Unclear risk | The distribution of small and larger diameter implants is different in the two groups. There are more large diameter implants in the immediate loading group |