Patel 2013.
Study characteristics | ||
Methods | Trial design: randomised, parallel‐group trial Location: London, UK Number of centres: single centre, Clinical Investigation Centre, UCL Eastman Dental Institute, London, UK Recruitment period: 2006 to 2008 Funding source: the study was supported by a grant from the Institut Straumann AG, Basel, Switzerland |
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Participants | Inclusion criteria: age between 18 and 75 years; good general health; the presence of a hopeless tooth in the mandibular or the maxillary incisor, canine, or premolar region requiring extraction and would be suitable for replacement by a dental implant; the tooth to be extracted has at least 1 neighbouring tooth; the subject had voluntarily signed the informed consent Exclusion criteria: pregnancy or lactating period; chronic treatment with any medication known to affect oral status and bone turnover or contraindicate surgical treatment within 1 month of baseline visit; concomitant anticoagulant therapy; any known diseases (not including controlled diabetes mellitus); infections or recent surgical procedures within 30 days of study initiation; HIV or hepatitis; administration of any other investigational drug within 30 days of study initiation; limited mental capacity or language skills or suffering from a known psychological disorder; heavy smoking (> 10 cigarettes per day); uncontrolled or untreated periodontal disease; full‐mouth plaque level (FMPL) > 30% at the enrolment visit; severe bruxism; acute endodontic lesion in the test tooth or in the neighbouring areas; major part of the buccal or palatal osseous wall damaged or lost following tooth extraction Age at baseline: mean age 37.3 ± 11.4 years (20 to 58) Gender: M 6/F 21 Smokers: 3 Teeth extracted: non‐molar sites Number randomised (participants/sites): 30/30 Number evaluated (participants/sites): 25/25 (radiographic evaluation 24/24) |
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Interventions |
Comparison: ARP (grafting material) versus ARP (grafting material) Test group: (n = 13 extraction sockets) synthetic bone substitute‐Straumann bone ceramic (SBC) (Straumann AG, Basel, Switzerland, granule size 400 μm to 1000 μm) + collagen barrier (Bio‐Gide, Geistlich, Basel, Switzerland) Control group: (n = 12 extraction sockets) deproteinised bovine bone mineral (DBBM) (Bio‐Oss, Geistlich Pharma AG, Basel, Switzerland) + collagen barrier (Bio‐Gide, Geistlich Pharma AG, Basel, Switzerland) Surgical technique: flap, no primary closure Type of socket: 4‐wall socket Duration of follow‐up: 8 months at implant placement (Mardas 2010); 12 months post‐loading (Patel 2013) |
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Outcomes | Width and height of alveolar ridge, probing pocket depth, gingival recession, implant survival, need for additional augmentation prior to implant placement Method of assessment: periodontal probe, standardised radiograph |
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Notes | Sample size calculation: reported The sample size was calculated based on previous literature and assumed difference in observed radiographic bone changes of 1 mm and standard deviation of 0.05 mm |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The subjects were randomly assigned to the test or the control group by a computer‐generated table. A balanced randomly permuted block approach was used to prepare the randomisation tables in order to avoid unequal balance between the two treatments" |
Allocation concealment (selection bias) | Unclear risk | It is not clear whether the randomised codes were enclosed in sequentially numbered, identical, opaque, and sealed envelopes |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All the periodontal and surgical measurements were made by a single, blinded examiner |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It is not clear whether the number and reasons of withdrawals had any impact on the results and how the authors managed the dropouts |
Selective reporting (reporting bias) | Low risk | All outcomes appear to be reported |
Other bias | Low risk | None detected |