Giniger 2005.

Methods	Title: a 180‐day clinical investigation of the tooth whitening efficacy of a bleaching gel with added amorphous calcium phosphate Trial design: double‐blinded randomised controlled trial Location: USA Language: English Number of centres: 1 Recruitment period: not reported Funding source: Discus Dental, Culver City, USA
Participants	Participants: continuation of a previously published study, 27 agreed to continue. Mean age 46.4 years Total number: 27 Inclusion criteria: absence of severe systemic diseases psychological diseases or both maxillary anterior tooth discolouration (equivalent to or darker than Vita shade A3) non‐use of any dentist‐supplied or ‐applied vital tooth bleaching treatment in the previous 6 months non‐user of any in‐office desensitising agent in the previous 6‐month period no periodontal surgery or scaling performed in the previous 6 months patients with no carious, non‐restored 6 max anterior teeth Exclusion criteria: not reported Number randomised: 27 Method of randomisation: stratified randomisation schedule Method of allocation concealment: secret coding Method of blinding: identical pack Number evaluated: 27
Interventions	Number of groups: 2 Control: 16% carbamide peroxide Experimental: 16% carbamide peroxide with 0.5% soluble calcium phosphate derived in part from calcium nitrate and potassium pyrophosphate Duration of treatment: 19 days
Outcomes	Improvement in tooth shade: Vita shade guide C1 (1) to B4 (16) Gingival Index score: 0 (no gingivitis) to 3 (severe gingivitis) Dentinal hypersensitivity: 0 (no pain) to 3 (pain during application of stimuli and immediately there after) VAS scale: 0 (no pain) to 10 (highest level of pain)
Notes	Adverse effects: none Key conclusions of the study authors: "This study demonstrated that the ACP product offers 10% better long‐term (6‐months) whitening efficacy that the traditional bleaching gel. No significant adverse effect. Tooth sensitivity, soft tissue health, and gingival health remained similar to baseline levels" Contact: Dr Giniger; mginiger@mg‐co.com
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: " ..we randomised subjects into test and control groups, according to a stratified randomisation schedule"
Allocation concealment (selection bias)	Low risk	Quote: "The evaluator of the teeth shades and sensitivity scores (MG) was blinded to this schedule.. other than a secret product code number known only to a co‐worker"
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "The evaluator of the teeth shades and sensitivity scores (MG) was blinded to this schedule, and the products looked identical to him and to the subjects"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The evaluator of the teeth shades and sensitivity scores (MG) was blinded to this schedule, and the products looked identical to him and to the subjects"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "All 27 requalified subjects completed the study"
Selective reporting (reporting bias)	Low risk	All outcomes described were reported. Conclusions are in accordance with the results
Other bias	Low risk	None