1. what is the trend of pain after initial wire placement.?
2. what is the effect of appliance type (e.g. self ligating vs. conventional appliance) on pain?
3. what is the effect of demographic factors(e.g.age, sex) on pain?
4. what is the effect of malocclusion severity (e.g. severity of crowding) on pain?
5. is there difference in pain for maxillary and mandibular arch?
6. what is the efficiency of various treatment options (e.g. NSAIDS, laser therapy, bite wafers etc.) for pain alleviation?
The following electronic databases were searched: MEDLINE (until June end, 2012), and Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 6, 2012). No restriction was applied for the starting date of search. Language restrictions were not applied. Papers not in English were included if they could be translated into English. Additional studies were identified by electronic and hand searching of following four orthodontic journals (from 1980, till June 2012): American Journal of Orthodontics and Dentofacial Orthopaedics, The Angle Orthodontist, the European Journal of Orthodontics and the Journal of Orthodontics; and by electronic searching of other peer-reviewed journals indexed in Medline by using Google Scholar (June 29, 2012). Unpublished literature will be searched electronically using ClinicalTrials.gov (www.clinicaltrials.gov) and the National Research Register (www.controlled-trials.com) using the term ‘orthodontic and pain’. In addition, Pro-Quest Dissertation Abstracts and Thesis database will be accessed (“www.lib.umi.com./dissertations”) using: “orthodontic*” and “pain*”.
Types of study to be included
Randomized and controlled clinical trials. Upper and/or lower fixed orthodontic appliance were to be included.
Condition or domain being studied
Initial levelling and aligning phase of fixed orthodontic treatment.
The selection inclusion criteria used for the review were: 1) Study design: randomized controlled clinical trials (RCTs) 2) Participants: patients with upper and/or lower full-arch, fixed, and bonded orthodontic appliances. 3) Interventions: initial aligning arch wires (Multistranded stainless steel and nickel titanium alloys); different fixed orthodontic appliances such as conventional Pre-adjusted Edgewise Appliance (PEA) or self- ligating appliances; various treatment modalities for pain control (e.g. NSAIDS, bite wafers, chewing gums, etc. 4) Outcome measures: the main outcome measure was the pain 5) Follow-up period: minimum of 7 days. Secondary outcomes included analgesic consumption, effect of pain on daily routine activities, and effect of pain on anxiety.
The exclusion criteria were: 1) Study other than randomised controlled clinical trial 2) Studies not investigating fixed appliance orthodontic treatment 3) Studies not investigating initial arch wire interventions as such, but rather as a part of arch wire sequence 4) studies with follow-up periods of less than 7 days.
Multistranded stainless steel and nickel titanium alloy wires during initial phase of orthodontic treatment, different appliance/brackets.
Various treatment modalities used for alleviating pain such as analgesic drugs (both premptive or post-orthodontic delivery), bite wafer, low-level laser therapy etc
Multistranded stainless steel vs. nickel titanium alloy wires in conventional vs. self ligating brackets. Other comparators should be placebo or other interventions listed in the Intervention (s), exposure (s) box.
Pain measured after placement of initial arch wire during the fixed orthodontic treatment and minimum follow up should be for 7 days. Follow up beyond 7 days will also be taken into account.
analgesic consumption, effect of pain on daily routine activities, and effect of pain on anxiety.
Data extraction, (selection and coding)
Assessment of included RCTs for risk of bias and data extraction was performed independently and in duplicate by both the reviewers, who were not blinded to the authors and the results of the research. Disagreements were resolved by discussion.
Data extraction involved the recording of the following data on a customized data collection form. 1) Study identification using first author’s name and year of publication. 2) Study design/method. 3) Participants, including Sample size, age of subjects and the number of male subjects and female subjects per study group. 4) Interventions, including details of material, size and brand of arch wires, type of fixed orthodontic appliances, treatment modalities such as NSAIDs, lasers, etc. 5) Duration of follow-up. 6) Outcome measures.
Risk of bias (quality) assessment
Authors will independently assess the risk of bias in included studies by
considering the following six items as proposed by Cochrane Collaboration:
Randomisation sequence generation
Treatment allocation concealment
Completeness of outcome data
Selective outcome reporting
Other sources of bias
in addition to these above mentioned factors, following other factors will also be considered for quality assessment:
sample size reported
sample size based on power analysis
eligibility criteria reported
baseline equality of groups for demographic data (age and sex)
estimate and standard deviations reported in results
adequate statistical analysis (major factor for analysis method judgement would be if correlation between repeated measure was taken into consideration during statistical analysis)
Strategy for data synthesis
We will provide a narrative synthesis of the findings from the included studies, structured around the type of intervention, target population characteristics, type of outcome and intervention content.
Based on the findings from the risk of bias assessment and the fact that the study designs (including great variations in time points used for recording of pain), participants, interventions, and reported outcome measures varied markedly, we focused on describing the studies, their results, their applicability, and their limitations and on qualitative synthesis rather than meta-analysis.” Therefore, the meta-analysis was not undertaken for this present review.
Analysis of subgroups or subsets
None planned because no data will be combined as no meta-analysis is undertaken.
Written publication in peer-reviewed orthodontic journal.
Contact details for further information
Satpal Singh Sandhu
# 47, Gujral Nagar,
Jalandhar - 144001
Organisational affiliation of the review
Dr Satpal Singh Sandhu, Genesis Institute of dental sciences and research Dr Jasleen Sandhu, Private practice
Anticipated or actual start date
10 June 2011
Anticipated completion date
20 September 2012
Conflicts of interest
Subject index terms status
Subject indexing assigned by CRD
Subject index terms
Humans; Orthodontic Wires; Pain
Date of registration in PROSPERO
07 August 2012
Date of publication of this revision
20 September 2012
Stage of review at time of this submission
Piloting of the study selection process
Formal screening of search results against eligibility criteria
Risk of bias (quality) assessment
PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites.