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 Unpublished literature will be searched electronically using ClinicalTrials.gov (www.clinicaltrials.gov) and the National Research Register (www.controlled-trials.com)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*”.

Randomized and controlled clinical trials. Upper and/or lower fixed orthodontic appliance were to be included.

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.

Primary outcomes

Orthodontic pain.

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.

orthodontic treatment.

Secondary outcomes

analgesic consumption, effect of pain on daily routine activities, and effect of pain on anxiety.

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.

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

Blinding

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)

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.

None planned because no data will be combined as no meta-analysis is undertaken.

Written publication in peer-reviewed orthodontic journal.

Satpal Singh Sandhu

# 47, Gujral Nagar,

Jalandhar - 144001

drsatpalsandhu@gmail.com

None

Dr Satpal Singh Sandhu, Genesis Institute of dental sciences and research
Dr Jasleen Sandhu, Private practice

10 June 2011

20 September 2012

None

None known

English

India

Subject indexing assigned by CRD

Humans; Orthodontic Wires; Pain

07 August 2012

20 September 2012