Clinical trial NCT04105127: Pain and Discomfort With Anterior Versus Posterior Builds-up
Official title: Pain and Discomfort With Anterior Versus Posterior Builds-up During Fixed Orthodontic Treatment: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malocclusion
Deep Bite
Lead sponsor: University of Genova
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 80
Sex: ALL
Minimum age (years): 9
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Orthodontic build-ups are made by composite/resin material bonded to the palatal or occlusal surfaces of teeth (usually molars or incisors). Their primary purpose is to prevent heavy contact of the upper teeth with lower fixed appliances in patients with overbite reduction to avoid brackets detachment. These appliances disarticulate the posterior teeth, deprogram the masticatory muscles and allow for eruption, extrusion, and uprighting of the posterior teeth. Build-ups are usually placed in the first months of the fixed orthodontic treatment and contribute to increasing the perception of pain. In the orthodontic daily practice, the pain is the most frequent symptom during treatment and is the one that most frightens/worries the patients. Literature shows that fear of pain is one of the primary reasons that patients fail to seek orthodontic care. Pain has a negative effect on patients' compliance, oral hygiene, and missed appointments. Its effects on patients' daily lives is a major reason for discontinuance of orthodontic treatment.

In the literature the prevention of pain and management of orthodontic builds-ups is a poorly analyzed topic, despite being a daily problem in orthodontic clinical practice. So, the aim of the present study is to investigate and analyze the perception of pain and function impairment with different type of build-ups (anterior or posterior) to identify an efficient clinical management protocol and an effective pain and discomfort prevention strategy.


Eligibility criteria: Inclusion Criteria:

* Patient with reduced overbite treated with orthodontic fixed appliance
* Angle Class I, Class II or Class III malocclusion

Exclusion Criteria:

* Hypodontia in any quadrant excluding third molars
* Craniofacial syndromes, or cleft lip or palate

Primary outcomes:
measure: Overbite correction [Millimeters]
timeFrame: 1 week
measure: Overbite correction [Millimeters]
timeFrame: 1 months
measure: Overbite correction [Millimeters]
timeFrame: 2 months
measure: Overbite correction [Millimeters]
timeFrame: 3 months
measure: Overbite correction [Time]
timeFrame: 1 months
measure: Overbite correction [Time]
timeFrame: 2 months
measure: Overbite correction [Time]
timeFrame: 3 months
measure: Pain after builds-up placement
timeFrame: 1 week
measure: Pain after builds-up placement
timeFrame: 1 months
measure: Pain after builds-up placement
timeFrame: 2 months
measure: Pain after builds-up placement
timeFrame: 3 months
measure: Oral Health Impact Profile after builds-up placement
timeFrame: 1 week
measure: Oral Health Impact Profile after builds-up placement
timeFrame: 1 months
measure: Oral Health Impact Profile after builds-up placement
timeFrame: 2 months
measure: Oral Health Impact Profile after builds-up placement
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Alessandro Ugolini
state: GE
Study officials:
References:
citation: Corridore D, Campus G, Guerra F, Ripari F, Sale S, Ottolenghi L. Validation of the Italian version of the Oral Health Impact Profile-14 (IOHIP-14). Ann Stomatol (Roma). 2014 Feb 4;4(3-4):239-43. eCollection 2013 Jul-Dec.
citation: Kravitz ND, Jorgensen G, Frey S, Cope J. Resin bite turbos. J Clin Orthod. 2018 Sep;52(9):456-461. No abstract available.
citation: Antoun JS, Thomson WM, Merriman TR, Rongo R, Farella M. Impact of skeletal divergence on oral health-related quality of life and self-reported jaw function. Korean J Orthod. 2017 May;47(3):186-194. doi: 10.4041/kjod.2017.47.3.186. Epub 2017 Mar 13.
citation: Pativetpinyo D, Supronsinchai W, Changsiripun C. Immediate effects of temporary bite-raising with light-cured orthodontic band cement on the electromyographic response of masticatory muscles. J Appl Oral Sci. 2018 May 14;26:e20170214. doi: 10.1590/1678-7757-2017-0214.