Eslamian, Ladan
(Dentofacial Deformities Research Center, School of Dentistry, Shahid Beheshti University of Medical Sciences)
,
Rad, Nazila Akbarian
(Department of Endodontics, School of Dentistry, Shahid Beheshti University of Medical Sciences)
,
Nobar, Behnam Rahbani
(Department of Endodontics, School of Dentistry, Shahid Beheshti University of Medical Sciences)
,
Mortazavi, Seyed Alireza
(School of Pharmacy, Shahid Beheshti University of Medical Sciences)
Background: The pain involved in orthodontic treatments may involve inflammatory processes. This study evaluated the effect of using a naproxen patch for pain reduction in the separating stage of fixed orthodontic treatment. Methods: In this double-blind, randomized, controlled clinical trial of 35 ...
Background: The pain involved in orthodontic treatments may involve inflammatory processes. This study evaluated the effect of using a naproxen patch for pain reduction in the separating stage of fixed orthodontic treatment. Methods: In this double-blind, randomized, controlled clinical trial of 35 orthodontic patients (age: 14-19 years) who had pain during separator placement, each patient randomly placed naproxen and placebo patches in the first permanent molar region, in opposite quadrants of the same jaw. Patches were replaced every 8 hours until 3 days after separator placement. Patients recorded their pain perception at 2, 6, and 24 hours, and on days 2 (6 PM), 3 (10 AM and 6 PM), and 7 (10 AM and 6 PM), using a visual analog scale. Mean pain scores were compared for the two patches, and effects of sex and age thereon determined. Results: Data from 29 patients (21 girls, eight boys) were analyzed. Mean pain values decreased over time for both patches (P < 0.001). Recorded pain did not differ significantly between the sexes (P = 0.059) or between those aged <16 and those ${\geq}16years$ (P = 0.106). Mean pain recorded with naproxen patches was statistically significantly less than that with placebo patches at all time points (P = 0.004). Conclusion: The naproxen patch was more efficient than the placebo patch for reducing pain at all time points. The highest pain score was recorded at 6 hours, and the least pain was recorded at the $7^{th}$ day after separator placement.
Background: The pain involved in orthodontic treatments may involve inflammatory processes. This study evaluated the effect of using a naproxen patch for pain reduction in the separating stage of fixed orthodontic treatment. Methods: In this double-blind, randomized, controlled clinical trial of 35 orthodontic patients (age: 14-19 years) who had pain during separator placement, each patient randomly placed naproxen and placebo patches in the first permanent molar region, in opposite quadrants of the same jaw. Patches were replaced every 8 hours until 3 days after separator placement. Patients recorded their pain perception at 2, 6, and 24 hours, and on days 2 (6 PM), 3 (10 AM and 6 PM), and 7 (10 AM and 6 PM), using a visual analog scale. Mean pain scores were compared for the two patches, and effects of sex and age thereon determined. Results: Data from 29 patients (21 girls, eight boys) were analyzed. Mean pain values decreased over time for both patches (P < 0.001). Recorded pain did not differ significantly between the sexes (P = 0.059) or between those aged <16 and those ${\geq}16years$ (P = 0.106). Mean pain recorded with naproxen patches was statistically significantly less than that with placebo patches at all time points (P = 0.004). Conclusion: The naproxen patch was more efficient than the placebo patch for reducing pain at all time points. The highest pain score was recorded at 6 hours, and the least pain was recorded at the $7^{th}$ day after separator placement.
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문제 정의
The objective of this study was to evaluate the efficacy of a naproxen patch in decreasing pain after the placement of elastic separators in patients undergoing fixed orthodontic treatment.
제안 방법
A split-mouth design was chosen for the main study in order to minimize individual differences affecting pain experience; this study design allowed comparison of case and control groups in the same patient.
After obtaining written informed consent from all the patients, the separators (American Orthodontics, Monrovia, CA, USA) were placed on the mesial and distal sides of permanent first molars of the right and left sides of one of the jaws, using a pair of orthodontic separator pliers (Dentaurum, Springen, Germany). Each patient was given a total of 18 patches (nine naproxen patches and nine placebo patches).
Based on this evidence, it was decided that a split-mouth design should be applied in this study, too. Furthermore, in order for the patients to assess their pain experience and record it over time, a VAS form was given to each patient to record their level of pain. Several previous studies used a VAS form and questionnaires to assess the level of pain experienced by the patients [22-28].
Subsequently, the patients were instructed to change the patch for a new patch every 8 hours. Moreover, they were asked to mark their pain on a visual analog scale (VAS) scoring form, with numbers ranging from 0 to 100 in 10-point intervals. Based on the information obtained from the pilot study, it was concluded that the naproxen patch should consist of the following:1) hydroxypropyl methylcellulose (2.
These patients were asked to place the patch on the gingival tissue of one of the permanent first molars and hold it there until the patch attached to the gingiva. Subsequently, the patients were instructed to change the patch for a new patch every 8 hours. Moreover, they were asked to mark their pain on a visual analog scale (VAS) scoring form, with numbers ranging from 0 to 100 in 10-point intervals.
Each group was coded in order to facilitate further investigation. The patients were instructed on how to place the patch along the margin of the buccal free-gingiva correctly, and hold it there until the patch attached to the gingiva. They were asked to change the patch every 8 hours for 3 days (the last one was used on the 4th day at 10 am) and mark the level of pain they experienced on a 0- to 100-point VAS scoring form after 2, 6, and 24 hours and on the 2nd, 3rd, and 7th day after placement of the patches.
Since perception of pain is subjective, it is difficult to evaluate and compare the level of pain between case and control groups in the presence of confounding factors. Therefore, in order to minimize these confounding factors and the individual differences caused by the diversities in pain perception, this study was structured to have a within-subject, split-mouth design. Previous studies, such as those by Kluemper et al.
The patients were instructed on how to place the patch along the margin of the buccal free-gingiva correctly, and hold it there until the patch attached to the gingiva. They were asked to change the patch every 8 hours for 3 days (the last one was used on the 4th day at 10 am) and mark the level of pain they experienced on a 0- to 100-point VAS scoring form after 2, 6, and 24 hours and on the 2nd, 3rd, and 7th day after placement of the patches. The age and sex of each patient were also recorded.
This study evaluated the efficacy of a 5% naproxen patch in reducing pain after orthodontic separator placement. The obtained results showed that the naproxen significantly reduced the pain significantly more than the placebo patch (P = 0.
대상 데이터
A total of 35 patients participated in this study. Six were excluded as they did not mention experiencing any pain, had not filled out the questionnaires correctly, or used systemic drugs.
Initially, a pilot study was performed in order to assess the taste, durability, adhesion properties, and the appropriate way for using this patch. A total of six patients were enrolled in this pilot study and were not included in the main study. These patients were asked to place the patch on the gingival tissue of one of the permanent first molars and hold it there until the patch attached to the gingiva.
Patients aged 14–19 years, who were candidates for fixed orthodontic treatment and needed separator placement for the banding of their first molars, were included in this study.
The patches were produced in the Shahid Beheshti University of Medical Sciences’ School of Pharmacy.
Patients aged 14–19 years, who were candidates for fixed orthodontic treatment and needed separator placement for the banding of their first molars, were included in this study. The patients were selected from among those who had been referred to a number of private orthodontic clinics and clinics associated with the Shahid Beheshti University of Medical Sciences during 2014 and 2015. The inclusion criteria were a lack of any systemic diseases, absence of periodontal or endodontic problems, age ranging between 14 and 19 years, tight contact of the first molar with the adjoining teeth, requirement of bilateral placement of elastic separators, absence of spacing, no use of systemic drugs for pain reduction, having antagonist teeth in the opposing arch, and absence of a posterior open bite.
데이터처리
Using the Kolmogorov–Smirnov test, the distribution of the data was evaluated and was found to be normal. Due to the existence of independent factors of time and the side of jaw to which the drug was applied, and non-independent factors of gender and age groups and the normal distribution of the data, a variance analysis parametric test was used. P < 0.
Multifactorial repeatedmeasures ANOVA was used to analyze the severity of pain between males and females and between age groups, and revealed that the level of pain was not significantly different between males and females (P = 0.059; Fig. 3) or between those aged <16 years or ≥16 years (P = 0.106; Fig. 4).
The differences in the severity of pain between males and females, and between patients younger than 16 old and ≥16 years, were analyzed using multifactorial repeatedmeasures analysis of variance (ANOVA).
이론/모형
05 were considered statistically significant. Pairwise comparisons of time points were made using the Bonferroni method. The differences in the severity of pain between males and females, and between patients younger than 16 old and ≥16 years, were analyzed using multifactorial repeatedmeasures analysis of variance (ANOVA).
성능/효과
It is also important to point out that the amount of naproxen in the patch was 5 mg, which was rather low (overall = 9 × 5 = 45 mg for all patches), and thus it could not have had any significant systemic effects. Based on the results of our pilot study, 5% naproxen was chosen as the lowest effective concentration for the drug patch. Additionally, 8-hour intervals were chosen for replacement and use of the patches, based on a previous study [14] and consultation with pharmacists, in order to minimize the side effects and increase patient cooperation.
Based on the significant difference in the level of pain between the case and control groups at all time intervals except the 7th day, it can be concluded that the 5% naproxen patch is efficient for pain reduction in the first few days after separator placement. Moreover, the highest level of pain was recorded at 6 and 24 hours after separator placement and was reduced to its lowest level by the 7th day.
The patients were selected from among those who had been referred to a number of private orthodontic clinics and clinics associated with the Shahid Beheshti University of Medical Sciences during 2014 and 2015. The inclusion criteria were a lack of any systemic diseases, absence of periodontal or endodontic problems, age ranging between 14 and 19 years, tight contact of the first molar with the adjoining teeth, requirement of bilateral placement of elastic separators, absence of spacing, no use of systemic drugs for pain reduction, having antagonist teeth in the opposing arch, and absence of a posterior open bite. The exclusion criteria were detachment of one of the separators, failure to apply the placebo or naproxen patch, not completing the questionnaire, and using systemic analgesic drugs.
The results obtained from this study revealed a significant difference between the two patches after 2, 6, and 24 hours and at the 2nd and 3x day, but not the 7th day after placement of the patches. The highest difference was observed after 24 hours and on day 2 at 6 pm (after 30 hours).
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