search
Back to results

Evaluation of the Levels of Pain, Discomfort, and Functional Impairment With Two Techniques of Retraction

Primary Purpose

Class II Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Mini-implants
Transpalatal arche (TPA)
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Malocclusion

Eligibility Criteria

17 Years - 27 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult healthy patients, Male and female, Age range: 17-27 years. Class II Division 1 malocclusion: Mild / moderate skeletal Class II (sagittal discrepancy angle 4< ANB<10) Overjet more than 5 mm. Normal overbite (more than 0 mm and less than 4 mm) Normal or increased anterior facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle) well-aligned maxillary teeth with minimal crowding (≤ 4 mm according to Little's index), 3- Complete permanent dentition (except for the third molars). 4- Existence of all the upper teeth (except third molars). 5- Good oral and periodontal health: Probing depth < 4 mm No radiographic evidence of bone loss. Gingival index ≤ 1 Plaque index ≤ 1 Exclusion Criteria: Medical conditions that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …) Presence of primary teeth in the maxillary arch Any craniofacial syndromes. Poor oral hygiene or Current periodontal disease: The patient had previous orthodontic treatment

Sites / Locations

  • University of Damascus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Retraction with mini-implants

Retraction with transpalatal arches

Arm Description

Mini-implants will be used as an anchor unit.

Transpalatal arches will be used as an anchor unit.

Outcomes

Primary Outcome Measures

Change in the levels of discomfort or pain
The degree of pain and discomfort that patients feel will be determined using their answers to the following question (question 01): Do you have pain at the site of the mini-implants/transpalatal arch? ' The four-point scale will be adopted to measure the degree of pain.
Change in the levels of swelling
The degree of swelling that patient feel will be determined using their answers to the following question (question 02): ' Do you have a sense of swelling at the site of the mini-implants/transpalatal arch?' four-point scale will be adopted to measure the degree of swelling.
Change in the levels of chewing difficulties
The degree of chewing difficulties that patients feel will be determined using their answers to the following question (question 03): ' Do you have difficulty chewing ' four-point scale will be adopted to measure the degree of chewing difficulties.
Change in the speaking difficulties
The degree of any speech problems that patients feel will be determined using their answers to the following question (question 04): ' Do you avoid specific types of speech (e.g., on the phone) ' Four-point scale will be adopted to measure the degree of chewing difficulties.
Change in the cleaning difficulties
The degree of any cleaning difficulties that patients feel will be determined using their answers to the following question (question 05): ' Do you find it difficult to clean the appliance and oral cavity? ' Four-point scale will be adopted to measure the degree of chewing difficulties.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2022
Last Updated
December 14, 2022
Sponsor
Damascus University
search

1. Study Identification

Unique Protocol Identification Number
NCT05652244
Brief Title
Evaluation of the Levels of Pain, Discomfort, and Functional Impairment With Two Techniques of Retraction
Official Title
Evaluation of Pain, Discomfort and Functional Impairment Associated With the Two-step Retraction Technique Anchored With Transpalatal Arches Versus the en Masse Retraction of Upper Anterior Teeth Anchored With Mini-implants: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 13, 2013 (Actual)
Primary Completion Date
May 3, 2014 (Actual)
Study Completion Date
January 24, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus 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
Thirty-eight patients requiring extraction of maxillary first premolars will participate in the study. They will be divided randomly into two groups: an en-masse retraction group and a two-step group. In each group, anterior teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side, Mini-implants will be used as an anchor unit in the en-masse retraction group, and TPA in the two-step's retraction group. The levels of pain, discomfort, and functional impairments will be self-reported using a validated questionnaire with a 4-points Likert scale.
Detailed Description
Pain associated with orthodontic treatment is one of the undesirable complications, which negatively affects the patient's cooperation. Pain may occur due to the pressure on the periodontal ligaments induced by orthodontic forces. The perception of pain is affected by many factors related to the patient, such as age, gender, and any previous treatment experiences, which are negatively or positively reflected in the patient's cooperation. As for the factors related to the type of orthodontic treatment provided. The levels of pain and discomfort vary with the different anchorage systems used during orthodontic treatment. Several methods have been proposed to assure good anchorages, such as headgear, transpalatal arch (TPA) with or without a Nance button, lingual arches, bonding of second molars, or intermaxillary elastics, and recently mini-implants. The use of mini-implants has recently become more common. The mini-implants have been used to secure absolute anchorage in en-mass retraction, canine retraction, total arch distalization, and anterior teeth intrusion. The most common usage is en-mass retraction of anterior teeth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Malocclusion

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
Retraction with mini-implants
Arm Type
Experimental
Arm Description
Mini-implants will be used as an anchor unit.
Arm Title
Retraction with transpalatal arches
Arm Type
Active Comparator
Arm Description
Transpalatal arches will be used as an anchor unit.
Intervention Type
Device
Intervention Name(s)
Mini-implants
Intervention Description
En masse retraction of upper anterior teeth will be applied where mini-implants will be used as an anchor unit. Anterior teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side.
Intervention Type
Device
Intervention Name(s)
Transpalatal arche (TPA)
Intervention Description
Two-step retraction of upper anterior teeth will be applied where transpalatal arches (TPAs) will be used as an anchor unit. Teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side.
Primary Outcome Measure Information:
Title
Change in the levels of discomfort or pain
Description
The degree of pain and discomfort that patients feel will be determined using their answers to the following question (question 01): Do you have pain at the site of the mini-implants/transpalatal arch? ' The four-point scale will be adopted to measure the degree of pain.
Time Frame
Time 1: after 24 hours; Time 2: on the 3rd day; Time 3: on the 7th day; Time 4: on the 14th day; Time 5: after 1 month
Title
Change in the levels of swelling
Description
The degree of swelling that patient feel will be determined using their answers to the following question (question 02): ' Do you have a sense of swelling at the site of the mini-implants/transpalatal arch?' four-point scale will be adopted to measure the degree of swelling.
Time Frame
Time 1: after 24 hours; Time 2: on the 3rd day; Time 3: on the 7th day; Time 4: on the 14th day; Time 5: after 1 month
Title
Change in the levels of chewing difficulties
Description
The degree of chewing difficulties that patients feel will be determined using their answers to the following question (question 03): ' Do you have difficulty chewing ' four-point scale will be adopted to measure the degree of chewing difficulties.
Time Frame
Time 1: after 24 hours; Time 2: on the 3rd day; Time 3: on the 7th day; Time 4: on the 14th day; Time 5: after 1 month
Title
Change in the speaking difficulties
Description
The degree of any speech problems that patients feel will be determined using their answers to the following question (question 04): ' Do you avoid specific types of speech (e.g., on the phone) ' Four-point scale will be adopted to measure the degree of chewing difficulties.
Time Frame
Time 1: after 24 hours; Time 2: on the 3rd day; Time 3: on the 7th day; Time 4: on the 14th day; Time 5: after 1 month
Title
Change in the cleaning difficulties
Description
The degree of any cleaning difficulties that patients feel will be determined using their answers to the following question (question 05): ' Do you find it difficult to clean the appliance and oral cavity? ' Four-point scale will be adopted to measure the degree of chewing difficulties.
Time Frame
Time 1: after 24 hours; Time 2: on the 3rd day; Time 3: on the 7th day; Time 4: on the 14th day; Time 5: after 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult healthy patients, Male and female, Age range: 17-27 years. Class II Division 1 malocclusion: Mild / moderate skeletal Class II (sagittal discrepancy angle 4< ANB<10) Overjet more than 5 mm. Normal overbite (more than 0 mm and less than 4 mm) Normal or increased anterior facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle) well-aligned maxillary teeth with minimal crowding (≤ 4 mm according to Little's index), 3- Complete permanent dentition (except for the third molars). 4- Existence of all the upper teeth (except third molars). 5- Good oral and periodontal health: Probing depth < 4 mm No radiographic evidence of bone loss. Gingival index ≤ 1 Plaque index ≤ 1 Exclusion Criteria: Medical conditions that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs), …) Presence of primary teeth in the maxillary arch Any craniofacial syndromes. Poor oral hygiene or Current periodontal disease: The patient had previous orthodontic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salma Al-Sibaie, DDS,MSc
Organizational Affiliation
Department of Orthodontics, University of Al-Baath Dental School, Hamah, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mudar Mohammad Mousa, DDS
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y. Hajeer, DDS,MSc,PhD
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Study Director
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
3863673
Citation
Oliver RG, Knapman YM. Attitudes to orthodontic treatment. Br J Orthod. 1985 Oct;12(4):179-88. doi: 10.1179/bjo.12.4.179.
Results Reference
background
PubMed Identifier
4531440
Citation
Haynes S. Discontinuation of orthodontic treatment relative to patient age. J Dent. 1974 Jul;2(4):138-42. doi: 10.1016/0300-5712(74)90041-4. No abstract available.
Results Reference
background
PubMed Identifier
17605489
Citation
Feldmann I, List T, Feldmann H, Bondemark L. Pain intensity and discomfort following surgical placement of orthodontic anchoring units and premolar extraction: a randomized controlled trial. Angle Orthod. 2007 Jul;77(4):578-85. doi: 10.2319/062506-257.1.
Results Reference
background
PubMed Identifier
21744200
Citation
Lehnen S, McDonald F, Bourauel C, Jager A, Baxmann M. Expectations, acceptance and preferences of patients in treatment with orthodontic mini-implants: part II: implant removal. J Orofac Orthop. 2011 Jul;72(3):214-22. doi: 10.1007/s00056-011-0026-3. English, German.
Results Reference
background
PubMed Identifier
21503849
Citation
Lehnen S, McDonald F, Bourauel C, Baxmann M. Patient expectations, acceptance and preferences in treatment with orthodontic mini-implants. A randomly controlled study. Part I: insertion techniques. J Orofac Orthop. 2011 Mar;72(2):93-102. doi: 10.1007/s00056-011-0013-8. English, German.
Results Reference
background

Learn more about this trial

Evaluation of the Levels of Pain, Discomfort, and Functional Impairment With Two Techniques of Retraction

We'll reach out to this number within 24 hrs