|Year : 2018 | Volume
| Issue : 1 | Page : 29-34
Comparison of the efficacy of ibuprofen and belladonna in the control of orthodontic separator pain
Harshal Ashok Patil1, Jaswant Patil2, Veerendra V Kerudi3, Pratik Jaltare3, Thaer Hamid4, Jitendra S Sharan5, Pawankumar Dnyandeo Tekale6
1 Practitioner, Jalgaon, India
2 Deep Ganga Total Health Solution, Mumbai, India
3 Department of Orthodontics, ACPM Dental College, Dhule, India
4 Private Orthodontic Practice; Cteo Duplo Slot School, Venâncio Aires-RS, Brazil
5 Department of Orthodontics and Dentofacial Deformities, Centre for Dental Education and Research, AIIMS, New Delhi, India
6 Department of Orthodontics, Dr. Rajesh Ramdasji Kambe Dental College and Hospital, Akola, Maharashtra, India
|Date of Web Publication||3-Apr-2018|
Dr. Harshal Ashok Patil
Private Orthodontic Practice, Aditya Chambers, Housing Society, Jalgaon - 425 001, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: The purpose of this study was to compare the efficacy of ibuprofen and Belladonna in the control of orthodontic pain and to ascertain the pain relief by Belladonna in comparison with ibuprofen during orthodontic separation. Materials and Methods: Patients, between 20 and 35 years of age, 51 females and 21 males, were included in this study. Patients were randomly divided into two groups; one group was assigned to ibuprofen 400 mg and second group was allocated to Belladonna 6C group. Patients were given two doses of medication of their respective groups, 1 h before placement of elastomeric separators (Ormco Separators, Ormco Corporation, CA, USA) which was administered in the department and one dose 6 h after the placement. Pain scores recorded on visual analogue scale (VAS). VAS was a 10 cm scale with millimetre calibration to record their pain at the following intervals, 2 h after placement, 6 h after placement, bedtime, day 1 morning, day 2 morning, day 3 morning and day 5 morning. Results: Post hoc comparisons indicated that there was no difference between the two groups at 2 h (P = 0.77), 6 h (0.073), 1 day (P = 0.120), 2 days (P = 0.283), 3 days (P = 0.363), 5 days (P = 0.622) and 7 days. Conclusion: Ibuprofen and Belladonna 6C are effective and provide adequate analgesia with no statistically significant difference. Lack of adverse effects with Belladonna 6C makes it an effective and viable alternative.
Keywords: Belladonna, Homoeopathy, Orthodontic pain, Separator
|How to cite this article:|
Patil HA, Patil J, Kerudi VV, Jaltare P, Hamid T, Sharan JS, Tekale PD. Comparison of the efficacy of ibuprofen and belladonna in the control of orthodontic separator pain. Indian J Res Homoeopathy 2018;12:29-34
|How to cite this URL:|
Patil HA, Patil J, Kerudi VV, Jaltare P, Hamid T, Sharan JS, Tekale PD. Comparison of the efficacy of ibuprofen and belladonna in the control of orthodontic separator pain. Indian J Res Homoeopathy [serial online] 2018 [cited 2019 May 20];12:29-34. Available from: http://www.ijrh.org/text.asp?2018/12/1/29/229071
| Introduction|| |
Orthodontics is a specialised branch of clinical dentistry which uses the force/s as a tool for correction of various dentofacial malocclusion and deformities. Contemporary to medical sciences force/forces acts as a drug in orthodontia which are desired to bring out various dentofacial improvement; however, very frequently such force or force systems lead to pain/discomfort to the patients which may render a negative attitude towards the orthodontic care. The present widely recognised and accepted analgesics such as non-steroidal anti-inflammatory drugs (NSAIDs) have been proved to be effective and efficient in control of such unpleasant experience during orthodontic treatment; however, these preparations have an anti-inflammatory effect, which is extremely undesirable factor as it prevents orthodontic tooth movement by suppressing the inflammatory reactions which is very much desired for orthodontic tooth movement. Dr. Samuel Hahnemann in the year 1796 created a system of alternative medicine based on his doctrine of Similia similibus curentur which means Like cures Like. Homoeopathy is debated field for many years. The results of Homoeopathy are not due to placebo-like effect which is contrary to the main stream thinking. Homoeopathic practice still continues to exist in many parts of the world and is believed to be specifically efficient and effective in curing chronic diseases which have only symptomatic treatment in the modern system of medicine. A deeper insight into homoeopathic literature brings into light on various analgesic preparations, for example, Belladonna and Arnica amongst which Belladonna is preferred medication in cases of acute pain.,
Tooth movement in orthodontics begins with insertion of elastomeric separators which are used to create the space for placement of band material around the tooth for attachment of bracket and auxiliaries are known to cause discomfort and pain to the patient in its initial days. Pain after separator placement increases gradually from the 4th hour to the 24th hour, but it subsides around the 7th day. An effective control of pain can have a huge impact on the perception of orthodontic care on the patient's mind and can significantly minimises the apprehension towards the treatment and in still a positive mental attitude towards the treatment.
NSAIDs have stood the test of time when it comes to pain management; however, they also come with an inherent property of being anti-inflammatory, thus basically acting against the theory of tooth movement. Paracetamol has a central site of action by inhibiting COX-3 centrally, thus not interfering with tooth movement, but it has been found that the efficacy of paracetamol is less than that of ibuprofen, which is peripherally acting non-selective COX inhibitor. It has been debated that single dose of NSAIDs is not sufficient enough to prevent tooth movement; however, the possibility still exists and the doors to search for alternatives remain wide open while considering ibuprofen as an established standard.
The purpose of the present study was to compare the efficacy of ibuprofen and Belladonna in the control of orthodontic pain and to ascertain the pain relief by Belladonna in comparison with ibuprofen during orthodontic separation.
| Materials and Methods|| |
The study's experimental design and protocol were approved by the Ethical Committee of the ACPM Dental College, Dhule, Maharashtra, India. This study was conducted in Department of Orthodontics and Dentofacial Orthopedics of ACPM Dental College, Dhule, Maharashtra, India. Eighty patients, between 20 and 35 years of age, 51 females and 21 males, scheduled to undergo fixed appliance treatment, agreed to participate in the study. Patients were explained about the study, and informed consent was obtained from the patients. Cases with non-extraction treatment plan having proper contacts' mesial and distal to permanent first molar and currently not taking any analgesics or antibiotics were included in the study. Patients consuming analgesics or anti-inflammatory drugs or having a history of bronchial asthma, any history of hepatic or renal diseases, peptic ulceration or allergy to ibuprofen were excluded from the study.
Patients were randomly divided into two groups; one group was assigned to ibuprofen 400 mg and second group was allocated to Belladonna 6C group. In the Belladonna 6C group, four globules given to patient. Patients were given two doses of medication of their respective groups, 1 h before placement of elastomeric separators (Ormco Separators, Ormco Corporation, CA, USA) which was administered in the department and one dose 6 h after the placement.
A set of seven printed pages of visual analogue scale (VAS) along with instruction of how to record pain response (including local language) was given to patients. VAS was a 10 cm scale with millimetre calibration to record their pain at the following intervals: 2 h after placement, 6 h after placement, bedtime at 9 pm, day 1 morning, day 2 morning, day 3 morning and day 5 morning. Patients were asked to mark the appropriate response they felt on chewing and biting. Patients were instructed to call the attending doctor if he/she felt the pain unbearable so that necessary analgesic treatment can be administered to the patient.
Data were analysed using SPSS Inc. Released 2007. SPSS for Windows, Version 16.0. Chicago, SPSS Inc. Findings were summarised with the use of frequencies and percentages for categorical variables and means and standard deviations (SD) for continuous variables. Chi-square tests were used to compare proportion, and unpaired t-tests were used to compare the mean of continuous data in two groups. The null hypothesis presumed that there was no significant difference of the pain score at different time intervals which was the basis of analysis in between the two groups. Repeated measure ANOVA and simple effects tests were used to estimate VAS pain difference according to time and group. P values reported were two tailed and were considered significant at the 0.05 level.
| Results|| |
In eighty patients, 51 (63.8%) females and 29 boys (36.3%) were included in the study. In ibuprofen group, 67.5% were female patients, and in Belladonna group, 60% were females. Mean age of patients in ibuprofen group was 21.8 (3, SD) years and in Belladonna group was 21.9 (3.2, SD) years [Table 1]. There was statistically no significant difference in the sex (P = 0.485) and age (P = 0.914) of patients included in either of two groups [Table 2].
|Table 1: Comparison of difference sex of patients in ibuprofen and Belladonna group|
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Post hoc comparisons indicated that that there was no difference between the two groups at 2 h (P = 0.77), 6 h (0.073), 1 day (P = 0.120), 2 days (P = 0.283), 3 days (P = 0.363), 5 days (P = 0.622) and 7 days though the VAS pain was higher in Belladonna group than ibuprofen group [Table 3]. Mean VAS pain score at different time intervals after separator placement in ibuprofen and Belladonna group is given in [Figure 1].
|Figure 1: Mean visual analogue scale pain score at different time intervals after separator placement in Ibuprofen and Belladonna group|
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There was a statistically significant effect of time on VAS pain score (F = 1383.1, P < 0.001), but there was no significant interaction between time and group (F = 1.02, P > 0.05). Indicating that there was no significant (P > 0.05) difference of pain score between the groups' different time intervals. Between subject, there was statistically no significant (F = 140, P > 0.05) difference of VAS pain in between the groups [Table 4].
| Discussion|| |
Pain experienced during orthodontic treatment is not trifling and needs to be taken care of from the first appointment with the orthodontist. Although a wide range of patient responses are present, pain and discomfort are generally experienced, which may instil a negative approach towards the treatment, or in very few cases may lead to discontinuation.
Minor et al. found that preemptive administration of ibuprofen significantly reduces pain scores as compared to post-separator placement and placebo group, also the peak plasma level concentration of ibuprofen in blood reaches in 1 h; hence, administration of ibuprofen 1 h before placement of separators was decided for the study.
Previous studies that have been conducted to compare the efficacy of various NSAIDs showed that ibuprofen 400 mg is consistent in reducing the pain scores when compared to placebo groups;, however, Naproxen sodium has proved to be better than ibuprofen and placebo groups, whereas another study suggested that Naproxen sodium and paracetamol were at par to placebo groups. These previous studies show that conventional analgesics typically accepted by modern medicine may also fail to achieve the desired level of analgesia. However, ibuprofen had consistently proved its efficacy and also in the performed study. Gastric irritation is a common side effect possible with consumption of NSAIDs such as ibuprofen, although single dose administration clinically does not produce the aforementioned symptom; however, the potential of side effect still cannot be ruled out. Homoeopathic medications have no proven side effect.
The results of the present study indicated that peak pain levels were maximum after 24 h of placement and the average scores during the first 24 h of placement indicated that ibuprofen group was more effective than Belladonna 6C but here was no significant statistical difference present between the two groups in the first 24 h. Pain scores decreased after 24 h and but Belladonna 6C group scores were lesser than that of ibuprofen, which might be attributed to half-life of ibuprofen which is 1.8–2 h and the drug is completely eliminated from the system in 24 h., After 24 h, average Belladonna 6C pain scores are lower than ibuprofen group.
| Conclusions|| |
- Ibuprofen and Belladonna 6C are effective and provide adequate analgesia with no statistically significant difference
- Lack of adverse effects with Belladonna 6C makes it an effective and viable alternative.
Financial support and sponsorship
Conflicts of interest
| References|| |
Eames S, Darby P. Homeopathy and its ethical use in dentistry. Br Dent J 2011;210:299-301.
Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, et al.
Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997;350:834-43.
Polat O, Karaman AI. Pain control during fixed orthodontic appliance therapy. Angle Orthod 2005;75:214-9.
Bradley RL, Ellis PE, Thomas P, Bellis H, Ireland AJ, Sandy JR, et al.
Arandomized clinical trial comparing the efficacy of ibuprofen and paracetamol in the control of orthodontic pain. Am J Orthod Dentofacial Orthop 2007;132:511-7.
Minor V, Marris CK, McGorray SP, Yezierski R, Fillingim R, Logan H, et al.
Effects of preoperative ibuprofen on pain after separator placement. Am J Orthod Dentofacial Orthop 2009;136:510-7.
Janssen GM, Venema JF. Ibuprofen: Plasma concentrations in man. J Int Med Res 1985;13:68-73.
Ross JM, DeHoratius J. Non narcotic analgesics. In: DiPalma JR, DiGregorio GJ, editors. Basic Pharmacology in Medicine. 3rd
ed. New York: McGraw Hill Publishing Company; 1990. p. 311-6.
Antal EJ, Wright CE 3rd
, Brown BL, Albert KS, Aman LC, Levin NW, et al.
The influence of hemodialysis on the pharmacokinetics of ibuprofen and its major metabolites. J Clin Pharmacol 1986;26:184-90.
[Table 1], [Table 2], [Table 3], [Table 4]