search
Back to results

Evaluation of Pain, Discomfort and Acceptance During the Orthodontic Treatment of Class III Malocclusion

Primary Purpose

Class III Malocclusion, Cross Bite, Orthodontic Appliance Complication

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Removable Mandibular Retractor
Bone-anchored intermaxillary traction
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class III Malocclusion focused on measuring Removable Mandibular Retractor, Bone-anchored Intermaxillary Traction

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Class III malocclusion according to Angle
  2. Presence of anterior cross bite on two teeth or more
  3. Class III Skeletal relationship confirmed radiographically (-4<ANB<+1)
  4. The lower incisors have normal inclination (Incisor-Mandibular-Plane angle not exceeding 100° and not less than 85°)
  5. Late mixed dentition or the beginning of the permanent dentition
  6. Eruption of The lower canines and first premolars on both sides
  7. Absence of craniofacial syndromes or cleft lip and/or palate abnormalities
  8. no supernumerary teeth or missing teeth except for the third molars
  9. no previous orthodontic treatment

Exclusion Criteria:

  1. Pure maxillary deficiency
  2. Pure mandibular prognathism
  3. Diseases that prevent the application of mini-implants (e.g. Osteoporosis- cortisone and its derivatives treatment - radiation)
  4. The roots of the canine are so close to the first premolar
  5. Long face (Maxillary-mandibular plane angle greater than 30° or Mandibular-Cranial-Base angle greater than 36°).

Sites / Locations

  • Orthodontic Department, University of Hama Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Removable Mandibular Retractor

Bone-anchored intermaxillary Traction

Arm Description

Patients in this group will be treated by the Removable Mandibular Retractor (RMR) in order to get rid of the anterior cross bite. This appliance is removable.

Patients will be treated using bone-anchored intermaxillary traction. Class III elastics will be extended from the Adam's clasps placed in the upper removable appliance towards the heads of mini-implants placed between the permanent canine and lateral incisors on either side of the lower dental arch.

Outcomes

Primary Outcome Measures

Change in the sensation of tension or pressure
Patients will be asked this question about their sensation of tension or pressure (Item no 01): Do you have a sense of tension and pressure in your soft tissues? A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Change in the perception of pain
Patients will be asked this question about their perception of pain (Item no 02): 'Have you experienced any degree of pain?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Change in the perception of speech
Patients will be asked this question about any change encountered in the articulation of sounds (Item no 03): 'Do you feel that your articulation has changed?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Change in swallowing ability
Patients will be asked this question about any difficulties encountered during swallowing (Item no 04): 'Do you have difficulty in swallowing?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Change in mandibular restriction
Patients will be asked this question about any restrictions encountered in lower jaw movements (Item no 05): 'Do you have a sense of your mandible movement being restricted?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Change in self-confidence perception
Patients will be asked this question about their feelings when meeting other people regarding self-confidence (Item no 06): 'Do you have any feeling of embarrassment or lack of confidence?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.

Secondary Outcome Measures

Full Information

First Posted
June 4, 2019
Last Updated
June 4, 2019
Sponsor
Damascus University
Collaborators
Hama University
search

1. Study Identification

Unique Protocol Identification Number
NCT03976635
Brief Title
Evaluation of Pain, Discomfort and Acceptance During the Orthodontic Treatment of Class III Malocclusion
Official Title
Evaluation of Pain, Discomfort and Acceptance During the Orthodontic Treatment of Class III Malocclusion Using Bone-anchored Intermaxillary Traction Versus the Removable Mandibular Retractor: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 15, 2015 (Actual)
Primary Completion Date
October 1, 2015 (Actual)
Study Completion Date
May 10, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University
Collaborators
Hama University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate the levels of pain, discomfort and acceptance between two treatment modalities of Class III correction of growing patients in the late mixed dentition period.
Detailed Description
The acceptance of orthodontic appliance is measured by the amount of discomfort occurring during orthodontic treatment. Different feelings can be encountered during the course of orthodontic treatment such as pressure, tension and pain. Pain is defined as an unpleasant feeling and a bad subjective experience combined with internal or external reason and it is considered as the most annoying factor during orthodontic treatment with fixed appliance. In a study by Oliver and Knappman, patients stated that the worse thing related to the orthodontic treatment was pain and 70% of the subjects suffered from pain during orthodontic treatment regardless the appliance' type. The fear from the pain is considered as the most important factor that not encourage patient to ask orthodontic treatment.Many studies demonstrated that there were no differences in the amount of the pain resulted from the orthodontic treatment between males and females [2, 5]. In a study of the reasons which make patient stopped the orthodontic treatment, Haynes found that the pain was the first reason, whereas the second one was the effect of the orthodontic appliance on the patient's daily social life. When reviewing the medical literature, few studies have been found to identify the patient acceptance degree to the orthodontic appliance used for treating Class III cases in general and Class III functional appliances in particular.Removable appliances were evaluated by a series of publications by Sergl et al in Germany.Additionally, when rigorous study designs are considered utilizing randomized controlled trials (RCTs), there are only few RCTs in the dental literature that evaluated patients' responses towards orthodontic treatment. Idris et al., evaluated Class II growing patients undergoing functional orthopedic corrections, whereas Khattab et al., compared labial brackets versus lingual brackets in terms of speech and functional impairments. Recently, Saleh et al., evaluated the levels of acceptance towards the removable mandibular retractor (RMR) when treating young children with Class III malocclusion in the late primary dentition and early mixed dentition (i.e. between 5 and 9 years) and found high levels of acceptance recommending the need for further analysis of patients' responses to this appliance in older age groups. Bone-anchored intermaxillary elastics have been proposed as a method of correcting Class III deformities. Although this method was compared to the removable mandibular retractor in terms of skeletal and dentoalveolar changes, but the published paper did not report any information about the associated levels of pain and discomfort as well the general acceptability to this treatment modality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class III Malocclusion, Cross Bite, Orthodontic Appliance Complication
Keywords
Removable Mandibular Retractor, Bone-anchored Intermaxillary Traction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Removable Mandibular Retractor
Arm Type
Active Comparator
Arm Description
Patients in this group will be treated by the Removable Mandibular Retractor (RMR) in order to get rid of the anterior cross bite. This appliance is removable.
Arm Title
Bone-anchored intermaxillary Traction
Arm Type
Experimental
Arm Description
Patients will be treated using bone-anchored intermaxillary traction. Class III elastics will be extended from the Adam's clasps placed in the upper removable appliance towards the heads of mini-implants placed between the permanent canine and lateral incisors on either side of the lower dental arch.
Intervention Type
Device
Intervention Name(s)
Removable Mandibular Retractor
Other Intervention Name(s)
RMR, Inferiorly extended labial bow, Reverse Hawley bow
Intervention Description
The appliance will be used 18 hours per day. It can only be removed for eating meals.
Intervention Type
Device
Intervention Name(s)
Bone-anchored intermaxillary traction
Other Intervention Name(s)
BAIMT
Intervention Description
The patients will be instructed to wear the upper removable appliance for 18 hours per day. The elastics should be extended from the upper appliance towards the lower mini-screws.
Primary Outcome Measure Information:
Title
Change in the sensation of tension or pressure
Description
Patients will be asked this question about their sensation of tension or pressure (Item no 01): Do you have a sense of tension and pressure in your soft tissues? A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Time Frame
Questionnaires will be filled at the following assessment times: one day following appliance insertion (T1), one week (T2), six weeks (T3), three months (T4) and after 6 months of appliance insertion (T5)
Title
Change in the perception of pain
Description
Patients will be asked this question about their perception of pain (Item no 02): 'Have you experienced any degree of pain?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Time Frame
Questionnaires will be filled at the following assessment times: one day following appliance insertion (T1), one week (T2), six weeks (T3), three months (T4) and after 6 months of appliance insertion (T5)
Title
Change in the perception of speech
Description
Patients will be asked this question about any change encountered in the articulation of sounds (Item no 03): 'Do you feel that your articulation has changed?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Time Frame
Questionnaires will be filled at the following assessment times: one day following appliance insertion (T1), one week (T2), six weeks (T3), three months (T4) and after 6 months of appliance insertion (T5)
Title
Change in swallowing ability
Description
Patients will be asked this question about any difficulties encountered during swallowing (Item no 04): 'Do you have difficulty in swallowing?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Time Frame
Questionnaires will be filled at the following assessment times: one day following appliance insertion (T1), one week (T2), six weeks (T3), three months (T4) and after 6 months of appliance insertion (T5)
Title
Change in mandibular restriction
Description
Patients will be asked this question about any restrictions encountered in lower jaw movements (Item no 05): 'Do you have a sense of your mandible movement being restricted?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Time Frame
Questionnaires will be filled at the following assessment times: one day following appliance insertion (T1), one week (T2), six weeks (T3), three months (T4) and after 6 months of appliance insertion (T5)
Title
Change in self-confidence perception
Description
Patients will be asked this question about their feelings when meeting other people regarding self-confidence (Item no 06): 'Do you have any feeling of embarrassment or lack of confidence?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the first six months of treatment. A four-point Likert scale is going to be used consisting of: (not at all), (little), (much) or (very much) to which points 0, 1, 2 and 3 respectively are going to be ascribed. Each questionnaire is going to be completed by the child in the presence of one of his/her parents.
Time Frame
Questionnaires will be filled at the following assessment times: one day following appliance insertion (T1), one week (T2), six weeks (T3), three months (T4) and after 6 months of appliance insertion (T5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Class III malocclusion according to Angle Presence of anterior cross bite on two teeth or more Class III Skeletal relationship confirmed radiographically (-4<ANB<+1) The lower incisors have normal inclination (Incisor-Mandibular-Plane angle not exceeding 100° and not less than 85°) Late mixed dentition or the beginning of the permanent dentition Eruption of The lower canines and first premolars on both sides Absence of craniofacial syndromes or cleft lip and/or palate abnormalities no supernumerary teeth or missing teeth except for the third molars no previous orthodontic treatment Exclusion Criteria: Pure maxillary deficiency Pure mandibular prognathism Diseases that prevent the application of mini-implants (e.g. Osteoporosis- cortisone and its derivatives treatment - radiation) The roots of the canine are so close to the first premolar Long face (Maxillary-mandibular plane angle greater than 30° or Mandibular-Cranial-Base angle greater than 36°).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdulmalek MR Majanni, DDS MSc
Organizational Affiliation
PhD student, Orthodontics Department, University of Damascus Dental School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS MSc PhD
Organizational Affiliation
Associate Professor of Orthodontics, University of Damascus Dental School
Official's Role
Study Director
Facility Information:
Facility Name
Orthodontic Department, University of Hama Dental School
City
Hamah
ZIP/Postal Code
12JO76WH
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9844209
Citation
Sergl HG, Klages U, Zentner A. Pain and discomfort during orthodontic treatment: causative factors and effects on compliance. Am J Orthod Dentofacial Orthop. 1998 Dec;114(6):684-91. doi: 10.1016/s0889-5406(98)70201-x.
Results Reference
background
PubMed Identifier
23075062
Citation
Khattab TZ, Farah H, Al-Sabbagh R, Hajeer MY, Haj-Hamed Y. Speech performance and oral impairments with lingual and labial orthodontic appliances in the first stage of fixed treatment. Angle Orthod. 2013 May;83(3):519-26. doi: 10.2319/073112-619.1. Epub 2012 Oct 18.
Results Reference
background
PubMed Identifier
22971260
Citation
Idris G, Hajeer MY, Al-Jundi A. Acceptance and discomfort in growing patients during treatment with two functional appliances: a randomised controlled trial. Eur J Paediatr Dent. 2012 Sep;13(3):219-24.
Results Reference
background
PubMed Identifier
23758461
Citation
Saleh M, Hajeer MY, Al-Jundi A. Assessment of pain and discomfort during early orthodontic treatment of skeletal Class III malocclusion using the Removable Mandibular Retractor Appliance. Eur J Paediatr Dent. 2013 Jun;14(2):119-24.
Results Reference
background
PubMed Identifier
30991984
Citation
Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
Results Reference
background

Learn more about this trial

Evaluation of Pain, Discomfort and Acceptance During the Orthodontic Treatment of Class III Malocclusion

We'll reach out to this number within 24 hrs