Abu‐Mostafa 2019.
| Study characteristics | ||
| Methods |
Study design: RCT Sample size calculation: not reported Sample size: 100 Setting: university clinics Number of centres: 1 Operators: dental interns Prevention or treatment of dry socket: prevention Type of teeth: single molar tooth Recruitment period: October 2016 to August 2017 Funding source: not reported Declarations of interest: not reported |
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| Participants |
Inclusion criteria: patients with upper or lower molar teeth indicated for extraction Exclusion criteria: patients with uncontrolled systemic diseases, epinephrine contraindications, pregnant women, breastfeeding women, and women who were using oral contraceptives. Patients with allergy to CHX, honey, lidocaine, and ibuprofen were also excluded. Other exclusion criteria included smoking, presence of acute infection, cystic lesions, traumatic extraction with fractured alveolar bone, extraction requiring bone reduction or root separation, and extractions that lasted more than 30 minutes Gender: 48 males, 52 females Mean age: 38.13 years Age range: 17 to 69 years Number randomised: 100 Number analysed: 100 Lost to follow‐up/dropouts: 0 |
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| Interventions |
All patients: regular postoperative care and verbal instructions, instructed to take 400 mg ibuprofen every 8 hours on 1st and 2nd day of the tooth extraction Intervention group 1: 0.2% CHX mouthwash twice daily for 7 days Intervention group 2: Manuka honey topically to extraction socket immediately and on 3rd postoperative day |
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| Outcomes |
Primary outcome measures: pain, assessment of socket for food debris and postextraction halitosis Diagnosis: VAS, clinical examination of socket, fetid odour from patients mouth during speech Secondary outcome measures: none reported Adverse outcomes: none reported |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk |
Quote: "Random allocation of the patients into the two parallel groups was done by asking them to choose 1 of the 2 colored cards. The green card indicated Group 1 while the blue indicated Group 2" Comment: there is a random element to this |
| Allocation concealment (selection bias) | High risk |
Quote: "Random allocation of the patients into the two parallel groups was done by asking them to choose 1 of the 2 colored cards" Comment: allocation is not concealed with colour of card denoting group allocation |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | It would not be possible to blind participants or personnel as this is a study comparing the professional application of a honey intrasocket versus patient rinsing with CHX. Participants knowing the intervention would probably not impact outcomes being assessed, but this is unlikely to have led to deviations from the intended intervention. Operators knowing the interventions are unlikely to have led to deviations from the intended intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | There is no mention of outcome assessor blinding |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All participants enrolled are accounted for but groups noticeably different in size. No details provided |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | High risk |
Quotes: "Extractions were performed by dental interns under close supervision of surgery instructors in the University Clinics" "Additionally, the patients were instructed to take 400 mg of ibuprofen every 8 hours on the 1st and 2nd day of the tooth extraction" Comment: a variety in operator experience may introduce bias especially if this is not equally distributed between the groups Adherence with pain relief regimen was not reported/recorded and could have impacted subjected reporting of pain on VAS |