Pain and Discomfort With Anterior Versus Posterior Builds-up

Malocclusion Clinical Trial

Official title:

Pain and Discomfort With Anterior Versus Posterior Builds-up During Fixed Orthodontic Treatment: a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04105127
• Other study ID #: RCT Builds-ups
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: September 2019
• Source: University of Genova
• Contact: Alessandro Ugolini, DDS Phd
• Phone: 3475971340
• Email: alessandro.ugolini[@]unige.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Bite
• Malocclusion

Intervention

Device:
• orthodontic - Anterior resin builds-ups
After lower brackets placement, resin builds-ups are added on the palatal aspect of the upper central incisors. Both central incisors are customarily bonded to broadly distribute the occlusal forces. Builds-ups are removed when the overbite was considered adequate to prevent lower brackets detachment.
• orthodontic - Posterior resin builds-ups
After lower brackets placement, resin builds-ups are added on the supporting cusps of first or second upper/lower molars. Builds-ups are removed when the overbite was considered adequate to prevent lower brackets detachment.

Locations

Country	Name	City	State
Italy	Alessandro Ugolini	Genova	GE

Sponsors (1)

Lead Sponsor	Collaborator
University of Genova

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View 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. — View Citation

Kravitz N, Jorgensen G, Frey S, Cope J. Resin bite turbos. J Clin Orthod. 2018 Sep;52(9):456-461. — View 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: 10.1590/1678-77 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overbite correction [Millimeters]	Overbite Clinical evaluation in vivo (continuous outcome, millimeters)	1 week
Primary	Overbite correction [Millimeters]	Overbite Clinical evaluation in vivo (continuous outcome, millimeters)	1 months
Primary	Overbite correction [Millimeters]	Overbite Clinical evaluation in vivo (continuous outcome, millimeters)	2 months
Primary	Overbite correction [Millimeters]	Overbite Clinical evaluation in vivo (continuous outcome, millimeters)	3 months
Primary	Overbite correction [Time]	Overbite Clinical evaluation in vivo (continuous outcome, months)	1 months
Primary	Overbite correction [Time]	Overbite Clinical evaluation in vivo (continuous outcome, months)	2 months
Primary	Overbite correction [Time]	Overbite Clinical evaluation in vivo (continuous outcome, months)	3 months
Primary	Pain after builds-up placement	Visual Analogic Scale (VAS) were used to evaluate the level of pain. The Visual Analog Scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end. Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain.	1 week
Primary	Pain after builds-up placement	Visual Analogic Scale (VAS) were used to evaluate the level of pain. The Visual Analog Scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end. Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain.	1 months
Primary	Pain after builds-up placement	Visual Analogic Scale (VAS) were used to evaluate the level of pain. The Visual Analog Scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end. Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain.	2 months
Primary	Pain after builds-up placement	Visual Analogic Scale (VAS) were used to evaluate the level of pain. The Visual Analog Scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end. Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain.	3 months
Primary	Oral Health Impact Profile after builds-up placement	Instrument of data collection was OHIP-14 questionnaire, which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- "never" to 4- "very often". Variables also included in the questionnaire were: demographic variables and satisfaction ratings of teeth appearance and self- rating of tooth condition. The satisfaction ratings of tooth appearance assessed how satisfied the participants were with the appearance of their teeth with a response of "satisfied or dissatisfied". The self- rating of tooth condition assessed oral condition as being "good or poor". The satisfaction ratings and self-ratings of oral health were variables used to assess the construct validity of OHIP-14 in the respondents	1 week
Primary	Oral Health Impact Profile after builds-up placement	Instrument of data collection was OHIP-14 questionnaire, which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- "never" to 4- "very often". Variables also included in the questionnaire were: demographic variables and satisfaction ratings of teeth appearance and self- rating of tooth condition. The satisfaction ratings of tooth appearance assessed how satisfied the participants were with the appearance of their teeth with a response of "satisfied or dissatisfied". The self- rating of tooth condition assessed oral condition as being "good or poor". The satisfaction ratings and self-ratings of oral health were variables used to assess the construct validity of OHIP-14 in the respondents	1 months
Primary	Oral Health Impact Profile after builds-up placement	Instrument of data collection was OHIP-14 questionnaire, which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- "never" to 4- "very often". Variables also included in the questionnaire were: demographic variables and satisfaction ratings of teeth appearance and self- rating of tooth condition. The satisfaction ratings of tooth appearance assessed how satisfied the participants were with the appearance of their teeth with a response of "satisfied or dissatisfied". The self- rating of tooth condition assessed oral condition as being "good or poor". The satisfaction ratings and self-ratings of oral health were variables used to assess the construct validity of OHIP-14 in the respondents	2 months
Primary	Oral Health Impact Profile after builds-up placement	Instrument of data collection was OHIP-14 questionnaire, which comprises of 14 questions with two questions each under seven domains. The domains include; functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability and handicap. Responses to the questions are based on a Likert scale which ranged from 0- "never" to 4- "very often". Variables also included in the questionnaire were: demographic variables and satisfaction ratings of teeth appearance and self- rating of tooth condition. The satisfaction ratings of tooth appearance assessed how satisfied the participants were with the appearance of their teeth with a response of "satisfied or dissatisfied". The self- rating of tooth condition assessed oral condition as being "good or poor". The satisfaction ratings and self-ratings of oral health were variables used to assess the construct validity of OHIP-14 in the respondents	3 months