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. 2018 Dec 18;2018(12):CD006202. doi: 10.1002/14651858.CD006202.pub2

Nathoo 2003.

Methods Title: comparative clinical investigation of tooth whitening efficacy of 2 whitening gels
Trial design: randomised, double‐blinded, parallel‐group trial
Location: Oral Health Clinical Services, Piscataway, New Jersey, USA
Language: English
Number of centres: 1
Recruitment period: not reported
Funding source: Colgate Palmolive
Participants Participants: 18 to 70 years old. Mean age 28.5 years
Total number: 59
Inclusion criteria:
  • 18 to 70 years of age

  • all maxillary anterior present with no restoration

  • no allergy to any of the ingredients of bleaching agent

  • Vita shade of A3 or darker


Exclusion criteria:
  • undergoing orthodontic treatment

  • anterior tooth with prosthesis or veneers, crowns

  • tumour of hard or soft tissues

  • pregnant/lactating females

  • oral prophylaxis in month or use of any whitening products

  • any illness


Number randomised: 59
Method of randomisation: not mentioned
Method of allocation concealment: not mentioned
Method of blinding: not mentioned
Number evaluated: 59
Interventions Total number of intervention groups: 2
Gel I: 25% carbamide peroxide
Gel II: 8.7% hydrogen peroxide
Duration of treatment: 3 weeks
Outcomes Improvement in tooth shade
The shade guide was arranged with 16‐shade tabs in order from B1 (1) to C4 (16)
Notes Sample size calculation: not reported
Adverse effects: none reported
Health‐related quality of life: not reported
Key conclusions of the study authors: "The authors concluded that all subjects exhibited statically significant tooth shade lightening. There was no significant difference in the between both gels for one time night usage for 2/3 weeks application. No adverse reaction was noted"
Correspondence required: no
Contact: Dr William DeVizio, William_devizio@colpal.com
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "double‐blinded, randomised, controlled, parallel‐group clinical trial." However, method of randomisation is not reported
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "double‐blinded, randomised, controlled, parallel‐group clinical trial." However, method of blinding is not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "double‐blinded, randomised, controlled, parallel‐group clinical trial." However, method of blinding is not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "All the participants 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