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

NCT03976635 | Completed DMC

• 1 other identifier: UDDS-Ortho-01-2019
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Class III Malocclusion; Cross Bite; Orthodontic Appliance Complication

Keywords

Removable Mandibular Retractor; Bone-anchored Intermaxillary Traction

Outcome Measures

Primary Outcomes (6)

• 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.

  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)

• 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.

  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)

• 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.

  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)

• 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.

  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)

• 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.

  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)

• 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.

  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)

Study Arms (2)

Removable Mandibular Retractor

ACTIVE COMPARATOR

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.

Device: Removable Mandibular Retractor

Bone-anchored intermaxillary Traction

EXPERIMENTAL

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.

Device: Bone-anchored intermaxillary traction

Interventions

Removable Mandibular Retractor DEVICE

The appliance will be used 18 hours per day. It can only be removed for eating meals.

Also known as: RMR, Inferiorly extended labial bow, Reverse Hawley bow

Removable Mandibular Retractor

Bone-anchored intermaxillary traction DEVICE

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.

Also known as: BAIMT

Bone-anchored intermaxillary Traction

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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°).

Sponsors & Collaborators

• Damascus University: lead
• Hama University: collaborator

Study Sites (1)

Orthodontic Department, University of Hama Dental School

Hama, 12JO76WH, Syria

Location

Related Publications (5)

• 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.

  PMID: 9844209 BACKGROUND

• 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.

  PMID: 23075062 BACKGROUND

• 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.

  PMID: 22971260 BACKGROUND

• 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.

  PMID: 23758461 BACKGROUND

• 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.

  PMID: 30991984 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class III; Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Abdulmalek MR Majanni, DDS MSc

  PhD student, Orthodontics Department, University of Damascus Dental School

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS MSc PhD

  Associate Professor of Orthodontics, University of Damascus Dental School

  STUDY DIRECTOR

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: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 6, 2019
• Study Start: February 15, 2015
• Primary Completion: October 1, 2015
• Study Completion: May 10, 2016
• Last Updated: June 6, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)