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. 2021 Apr 26;2021(4):CD010176. doi: 10.1002/14651858.CD010176.pub3

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
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)
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)
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
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
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