Table 2: Summary of eligible RCT studies.
Reference |
Country, Study Type, Total sample size |
Interventions, sample size per group |
Control intervention, sample size |
Inclusion criteria |
Gender and age (average ± SD, range in years) |
Amanlou, et al. [11] |
Iran, RCT, double blinded, N = 60 |
S. khuzistanica extract 3x day, n = 20 S. khuzistanica essential oil, n = 20 |
Hydroalcoholic vehicle (placebo), n = 20 |
(1) History of RAS (2) Currently suffering from ulceration located on the oral mucosa |
28M/32F 28.48 10-64 years |
Atanasovska Stojanovska, et al. [13] |
Macedonia, RCT, double blinded N = 20 |
Proaftol spray, n = 10 |
Control spray, n = 10 |
(1) RAS with a frequency of at least 3-4 times a year. |
No gender specified 20-30 years |
Babaee, et al. [14] |
Iran, randomized, double-blind, controlled before-after clinical trial N = 40 |
Myrtle oral paste, n = 40 |
Placebo oral paste, n = 40 |
(1) 18 years of age or older, (2) Clear history of RAS occurring at least twice a year, (3) Presenting with 1-3 aphthous ulcers (< 48 h duration), measuring no more than 10 mm in diameter, (4) Had an expectation that their ulcers normally takes > 5 days to resolve without treatment, (5) No underlying medical or hematological cause for their ulceration. |
17M/23 F 29.5 ± 10.3 18-58 years |
Babaee, et al. [15] |
Iran, RCT, double blinded N = 40 |
Aloe vera gel, n = 20 |
Placebo gel, n = 20 |
(1) Aged between 15 and 35 years (2) Minor recurrent aphthous singular lesions on their buccal mucosa and mucosal zone of the lips (after a medical diagnosis of RAS minor) (3) Without any other medical complications (4) Patients had noticed oral lesions during the last two days |
22M/18F Intervention group: 27.95 ± 7.96 years Placebo: 29.25 ± 7.48 years |
El-Haddad, et al. [16] |
Kingdom Saudi Arabia, RCT, single-blinded N = 94 |
Honey-treated group, n = 34 0.1% triamcinolone acetonide, n = 30 |
Orabase control group, n = 30 |
(1) Males and females aged from 18-60 years old. (2) Positive history of recurrent aphthous ulceration that normally last more than 5 days each episode without treatment. (3) Presence of 1-5 aphthous ulcers that present for less than 48 hours without treatment. (4) Ulcer size not greater than 5 mm in diameter. (5) The ulcers are available for topical application of the treated agent. |
28M/66F 18-60 years |
Hoseinpour, et al. [17] |
Iran, RCT, double-blinded N = 50 |
Mouth wash with Rosa damascene 1 minute, N = 25 |
Placebo, n = 25 |
(1) At least one aphthous ulcer measuring no more than 10 mm in diameter; (2) Duration of the ulcer(s) ≤ 48 hours; (3) Only patients with minor or herpetic form ulcerations were included. |
27M/23F Rosa: 34.4 ± 9.6 years; Placebo: 33.6 ± 14.4 21-59 years |
Jiang, et al. [10] |
China RCT, double-blinded N = 84 |
Berberine gelatin (10 g) containing 50 mg berberine, n = 42 |
Placebo agent, n = 42 |
(1) Both genders aged 18 to 50 years; (2) A history of RAS for a minimum of 6 months with an average of 1 to 2 outbreaks per month and 1 to 5 minor aphthae per outbreak; (3) No analgesics use or other drugs curing oral ulcer during the study; (4) 1 to 3 aphthous ulcerations with a size _5 and _10 mm in diameter; for more than 1 ulceration, a distance between ulcerations of more than 1 cm; (5) Time of ulceration onset within 48 hours; (6) Ulcers in locations that are easily accessible for evaluation and treatment. |
Gender Berberine: 14 M/28F Placebo: 10M/32 F Berberine: 30.86 ± 7.53 19-51 years Placebo: 31.19 ± 6.00 20-45 years |
Liu, et al. [18] |
China, RCT, double blinded, N = 240 randomized, N = 227 Completed the study |
Toothpaste 0.65% Yunnan Baiyao, n = 113 |
Placebo toothpaste, n = 114 |
(1) Both male and female aged 18 to 65-years-old; (2) Patients diagnosed as minor recurrent aphthous stomatitis with the duration of each ulcer in excess of 5 days; (3) Fresh ulcers available with less than 72 hours eruption. |
53M/174F Yunnan: 31.9 ± 10.9 Placebo: 31.4 ± 11.8 |
Mansour, et al. [19]
|
Saudi Arabia, RCT, double blinded N = 90 |
Mucoadhesive gel with aloe vera, n = 30 Mucoadhesive gel with myrrh extract, n = 30 |
Mucoadhesive gel (placebo), n = 30 |
(1) Presenting with 1-3 minor fresh RAS lesions, with duration < 48 h, and not greater in diameter than 5 mm. (2) If any participant had more than one ulcer, the one selected for evaluation was the most recent one. |
38M/52F 31.7 ± 8.4 18-36 years |
Pourahmad, et al. [20]
|
Iran, RCT, double blinded N = 93 |
Camel thorn distillate, n = 49 |
Distilled water, n = 44
|
(1) An aphthous lesion on their oral mucosa; (2) History of recurrent similar lesions. |
49M/44F Camel Thorn: 27.4 years Placebo: 31.8 years |
Yang, et al. [12]
|
China, RCT, double- Blinded N = 80 |
Pudilan toothpaste, n = 40
|
Placebo paste, n = 40
|
(1) 18 to 62-years-old; (2) have been confirmed as having minor aphthous ulcers (MiAUs) with 1-3 ulcerous lesions and a maximum lesion diameter < 10 mm; (2) Have had MiAUs diagnosed at least 6 months prior to this study and not have required medication for more than 5 days to recover from any episode; (3) Have had recent ulcerous lesions occurring within 48h prior to the study and not received any treatment. |
Unknown gender and age |
MiAUs: Minor Aphthous Ulcers.