Pain and Discomfort With Anterior Versus Posterior Builds-up

NCT04105127 | Unknown

• 1 other identifier: RCT Builds-ups
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion; Deep Bite

Outcome Measures

Primary Outcomes (15)

• Overbite correction [Millimeters]

  Overbite Clinical evaluation in vivo (continuous outcome, millimeters)

  1 week

• Overbite correction [Millimeters]

  Overbite Clinical evaluation in vivo (continuous outcome, millimeters)

  1 months

• Overbite correction [Millimeters]

  Overbite Clinical evaluation in vivo (continuous outcome, millimeters)

  2 months

• Overbite correction [Millimeters]

  Overbite Clinical evaluation in vivo (continuous outcome, millimeters)

  3 months

• Overbite correction [Time]

  Overbite Clinical evaluation in vivo (continuous outcome, months)

  1 months

• Overbite correction [Time]

  Overbite Clinical evaluation in vivo (continuous outcome, months)

  2 months

• Overbite correction [Time]

  Overbite Clinical evaluation in vivo (continuous outcome, months)

  3 months

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Anterior builds-ups

ACTIVE COMPARATOR

Intervention orthodontic - fixed orthodontic treatment in patients with overbite reduction: fixed orthodontic treatment with resin build-ups bonded to the palatal surfaces of central upper incisors

Device: orthodontic - Anterior resin builds-ups

Posterior builds-ups

ACTIVE COMPARATOR

Intervention orthodontic - fixed orthodontic treatment in patients with overbite reduction: fixed orthodontic treatment with resin build-ups bonded to the occlusal surfaces of first or second upper/lower molars

Device: orthodontic - Posterior resin builds-ups

Interventions

orthodontic - Anterior resin builds-ups DEVICE

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.

Also known as: Anterior resin bite turbos

Anterior builds-ups

orthodontic - Posterior resin builds-ups DEVICE

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.

Also known as: Posterior resin bite turbos

Posterior builds-ups

Eligibility Criteria

• Age: 9 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Genova: lead

Study Sites (1)

Alessandro Ugolini

Genova, GE, 16129, Italy

Location

Related Publications (4)

• 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.

  PMID: 24611088 RESULT

• Kravitz ND, Jorgensen G, Frey S, Cope J. Resin bite turbos. J Clin Orthod. 2018 Sep;52(9):456-461. No abstract available.

  PMID: 30256220 RESULT

• 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.

  PMID: 28523245 RESULT

• 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.

  PMID: 29768521 RESULT

MeSH Terms

Conditions

Malocclusion; Overbite

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Malocclusion, Angle Class II

Central Study Contacts

Alessandro Ugolini, DDS Phd

CONTACT

3475971340; alessandro.ugolini@unige.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: September 26, 2019
• Study Start: January 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)