Class II MalocclusionNCT05652244
Evaluation of the Levels of Pain, Discomfort, and Functional Impairment With Two Techniques of Retraction
A study testing Mini-implants and Transpalatal arche (TPA) in people with Class II Malocclusion, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 27 years
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- Mini-implants and Transpalatal arche (TPA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSyria
- Study dates
- 13 Jan 2013to 24 Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 27 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Class II Malocclusion
- Being tested
- Mini-implants, Transpalatal arche (TPA)
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-implantsDevice
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.
Transpalatal arche (TPA)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Retraction with mini-implants | Experimental | Mini-implants will be used as an anchor unit. Receives: Device: Mini-implants |
| Retraction with transpalatal arches | Active comparator | Transpalatal arches will be used as an anchor unit. Receives: Device: Transpalatal arche (TPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start13 Jan 2013
- Primary completion3 May 2014
- Study completion24 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Class II MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salma Al-Sibaie, DDS,MSc, Principal investigator, Department of Orthodontics, University of Al-Baath Dental School, Hamah, SyriaMudar Mohammad Mousa, DDS, Principal investigator, Department of orthodontics, Damascus University, SyriaMohammad Y. Hajeer, DDS,MSc,PhD, Study director, Department of orthodontics, Damascus University, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652244
- Sponsor's protocol ID
- UDDS-Ortho-16-2022
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oliver RG, Knapman YM. Attitudes to orthodontic treatment. Br J Orthod. 1985 Oct;12(4):179-88. doi: 10.1179/bjo.12.4.179.
PubMed 3863673Haynes 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.
PubMed 4531440Feldmann 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.
PubMed 17605489Lehnen 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.
PubMed 21744200Lehnen 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.
PubMed 21503849
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05652244
- Acronym / sponsor ID
- UDDS-Ortho-16-2022
- Conditions
- Class II Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 13 Jan 2013 (actual)
- Primary completion
- 3 May 2014 (actual)
- Study completion
- 24 Jan 2015 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retraction with mini-implants | Experimental | Device: Mini-implantsMini-implants will be used as an anchor unit. |
| Retraction with transpalatal arches | Active comparator | Device: Transpalatal arche (TPA)Transpalatal arches will be used as an anchor unit. |
Who may qualify
- Ages
- 17 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Adult healthy patients, Male and female, Age range: 17-27 years.
- Class II Division 1 malocclusion:
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini-implantsEn 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. | Device | Retraction with mini-implants |
| Transpalatal arche (TPA)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. | Device | Retraction with transpalatal arches |
Primary outcome
Change in the levels of discomfort or 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
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
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
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
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
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
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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Background: PubMed 3863673Oliver RG, Knapman YM. Attitudes to orthodontic treatment. Br J Orthod. 1985 Oct;12(4):179-88. doi: 10.1179/bjo.12.4.179.
- Background: PubMed 4531440Haynes 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.
- Background: PubMed 17605489Feldmann 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.
- Background: PubMed 21744200Lehnen 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.
- Background: PubMed 21503849Lehnen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salma Al-Sibaie, DDS,MSc principal investigator
Department of Orthodontics, University of Al-Baath Dental School, Hamah, Syria
Mudar Mohammad Mousa, DDS principal investigator
Department of orthodontics, Damascus University, Syria
Mohammad Y. Hajeer, DDS,MSc,PhD study director
Department of orthodontics, Damascus University, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-implants and Transpalatal arche (TPA) in people with Class II Malocclusion, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the levels of discomfort or 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05652244, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.