Pain and Discomfort With Anterior Versus Posterior Builds-up
Primary Purpose
Malocclusion, Deep Bite
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
orthodontic - Anterior resin builds-ups
orthodontic - Posterior resin builds-ups
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion
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
Sites / Locations
- Alessandro Ugolini
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Anterior builds-ups
Posterior builds-ups
Arm Description
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
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
Outcomes
Primary Outcome Measures
Overbite correction [Millimeters]
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Overbite correction [Millimeters]
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Overbite correction [Millimeters]
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Overbite correction [Millimeters]
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Overbite correction [Time]
Overbite Clinical evaluation in vivo (continuous outcome, months)
Overbite correction [Time]
Overbite Clinical evaluation in vivo (continuous outcome, months)
Overbite correction [Time]
Overbite Clinical evaluation in vivo (continuous outcome, 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.
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.
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.
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.
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
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
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04105127
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Genova
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Deep Bite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anterior builds-ups
Arm Type
Active Comparator
Arm Description
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
Arm Title
Posterior builds-ups
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
orthodontic - Anterior resin builds-ups
Other Intervention Name(s)
Anterior resin bite turbos
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
orthodontic - Posterior resin builds-ups
Other Intervention Name(s)
Posterior resin bite turbos
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overbite correction [Millimeters]
Description
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Time Frame
1 week
Title
Overbite correction [Millimeters]
Description
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Time Frame
1 months
Title
Overbite correction [Millimeters]
Description
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Time Frame
2 months
Title
Overbite correction [Millimeters]
Description
Overbite Clinical evaluation in vivo (continuous outcome, millimeters)
Time Frame
3 months
Title
Overbite correction [Time]
Description
Overbite Clinical evaluation in vivo (continuous outcome, months)
Time Frame
1 months
Title
Overbite correction [Time]
Description
Overbite Clinical evaluation in vivo (continuous outcome, months)
Time Frame
2 months
Title
Overbite correction [Time]
Description
Overbite Clinical evaluation in vivo (continuous outcome, months)
Time Frame
3 months
Title
Pain after builds-up placement
Description
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.
Time Frame
1 week
Title
Pain after builds-up placement
Description
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.
Time Frame
1 months
Title
Pain after builds-up placement
Description
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.
Time Frame
2 months
Title
Pain after builds-up placement
Description
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.
Time Frame
3 months
Title
Oral Health Impact Profile after builds-up placement
Description
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
Time Frame
1 week
Title
Oral Health Impact Profile after builds-up placement
Description
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
Time Frame
1 months
Title
Oral Health Impact Profile after builds-up placement
Description
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
Time Frame
2 months
Title
Oral Health Impact Profile after builds-up placement
Description
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
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Ugolini, DDS Phd
Phone
3475971340
Email
alessandro.ugolini@unige.it
Facility Information:
Facility Name
Alessandro Ugolini
City
Genova
State/Province
GE
ZIP/Postal Code
16129
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Ugolini
Phone
3475971340
Email
alessandro.ugolini@unige.it
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24611088
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.
Results Reference
result
PubMed Identifier
30256220
Citation
Kravitz ND, Jorgensen G, Frey S, Cope J. Resin bite turbos. J Clin Orthod. 2018 Sep;52(9):456-461. No abstract available.
Results Reference
result
PubMed Identifier
28523245
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.
Results Reference
result
PubMed Identifier
29768521
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.
Results Reference
result
Learn more about this trial
Pain and Discomfort With Anterior Versus Posterior Builds-up
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