Evaluation of the Levels of Pain and Discomfort Between Two Methods of Leveling and Alignment
15 april 2020 uppdaterad av: Damascus University
The Effect of Corticision on Perceived Pain and Discomfort for Patients With Crowded Lower Anterior Teeth: Randomized Clinical Trial
The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods.
Researches used minimally invasive surgical methods like corticision, piezocesion, micro-osteoperforation, and piezo-puncture indicated that most of these methods can accelerate dental movement by 20 - 40% without causing additional pain as a result of using those methods. Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Pain is defined as an unpleasant emotional sensory experience associated with actual or potential harm. It was mentioned as one of the most common complaints related to orthodontic treatment, and around 65-95% of patients undergoing orthodontic treatment suffer from various degrees of pain.
Corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. It was used to accelerate tooth movement in animals and case report studies. Its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique.
No study in the literature has been searched in patient perception of pain, discomfort, levels of acceptance and satisfaction accompanied corticision application, but in this study, these previous variables accompanied corticision technique have been studied on crowded lower anterior teeth cases which are one of the most common types of malocclusion.
Studietyp
Interventionell
Inskrivning (Faktisk)
26
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Damascus, Syrien Arabrepubliken, 00963
- Orthodontic Department, University of Damascus Dental School
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 24 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Age range between 18 and 24 years
- Completion permanent dentition (except third molars)
- Mild to moderate crowding (2-6 mm according to Little's index)
- Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment
Exclusion Criteria:
- Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery
- Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)
- Patients had previous orthodontic treatments
- Poor oral hygiene or concurrent periodontal disease
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Corticision
Patients will undergo a corticision procedure in order to accelerate tooth movement
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Surgical intervention is going to be used in the interdental areas between the lower anterior teeth to accelerate tooth movement.
Three incisions are going to be made
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Aktiv komparator: Traditional treatment
Patients will undergo traditional orthodontic treatment without any surgical intervention.
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No surgical intervention will be used, just normal orthodontic sequence of procedures.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in the Perception of Pain
Tidsram: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Pain is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of pain being experienced.
The left end of the line refers to no pain (VAS=0) where the right end refers to maximum (unimaginable) pain (VAS=100).
The level of pain is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the pain.
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At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Change in the Perception of Discomfort
Tidsram: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Discomfort is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of discomfort being experienced.
The left end of the line refers to no discomfort (VAS=0) where the right end refers to maximum discomfort (VAS=100).
The level of discomfort is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the discomfort.
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At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Change in the Perception of Swelling
Tidsram: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Swelling is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of swelling being experienced.
The left end of the line refers to no swelling (VAS=0) where the right end refers to maximum swelling (VAS=100).
The level of swelling is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the swelling
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At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Change in the Levels of Difficulties in Mastication
Tidsram: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Difficulties of mastication are assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulties in mastication being experienced.
The left end of the line refers to no difficulties (VAS=0) where the right end refers to maximum difficulties (VAS=100).
The level of difficulties in mastication is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the difficulties of mastication.
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At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Analgesic Consumption
Tidsram: The 7th day following the onset of treatment (i.e. at the second visit of the patients following his orthodontic appliance bonding; one-time assessment)
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Patients in both groups were asked about taking analgesics and their quantity (mg) They answered about taking analgesics using a two-point scale (1.
Yes or 2. No), and their quantity by mentioning how many tablets they took.
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The 7th day following the onset of treatment (i.e. at the second visit of the patients following his orthodontic appliance bonding; one-time assessment)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Patients' satisfaction
Tidsram: At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Satisfaction is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of satisfaction.
The left end of the line refers to no satisfaction (VAS=0) where the right end refers to maximum satisfaction (VAS=100).
The level of satisfaction is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the satisfaction.
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At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Ease of the procedure
Tidsram: At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Procedure's easiness is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of ease.
The left end of the line refers to no ease (VAS=0) where the right end refers to maximum ease (VAS=100).
The grade of ease is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the ease of the procedure.
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At the end of leveling and alignment which is expected to occur within 4 to 6 months
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The possibility of repeating the procedure
Tidsram: At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Patients in the corticision group will be asked about the possibility of repeating the procedure if they had the chance to give their decision again.
The answer will be collected using a two-point scale (1.
Yes or 2. No).
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At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Recommendation to a friend
Tidsram: At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Patients in the corticision group will be asked about if they would recommend this procedure to a friend.
The answer will be collected using a two-point scale (1.
Yes or 2. No).
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At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Mohamad Radwan Sirri, DDS MSc, MSc student in Orthodontics, University of Damascus Dental School
- Studiestol: Ahmad S Burhan, DDS MSc PhD, Professor of Orthodontics, University of Damascus, Damascus, Syria
- Studierektor: Mohammad Y Hajeer, DDS MSc PhD, Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- Alkebsi A, Al-Maaitah E, Al-Shorman H, Abu Alhaija E. Three-dimensional assessment of the effect of micro-osteoperforations on the rate of tooth movement during canine retraction in adults with Class II malocclusion: A randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):771-785. doi: 10.1016/j.ajodo.2017.11.026.
- Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
- Uribe F, Davoody L, Mehr R, Jayaratne YSN, Almas K, Sobue T, Allareddy V, Nanda R. Efficiency of piezotome-corticision assisted orthodontics in alleviating mandibular anterior crowding-a randomized clinical trial. Eur J Orthod. 2017 Nov 30;39(6):595-600. doi: 10.1093/ejo/cjw091.
- Yavuz MC, Sunar O, Buyuk SK, Kantarci A. Comparison of piezocision and discision methods in orthodontic treatment. Prog Orthod. 2018 Oct 29;19(1):44. doi: 10.1186/s40510-018-0244-y.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 mars 2017
Primärt slutförande (Faktisk)
15 september 2018
Avslutad studie (Faktisk)
15 februari 2019
Studieregistreringsdatum
Först inskickad
13 april 2020
Först inskickad som uppfyllde QC-kriterierna
15 april 2020
Första postat (Faktisk)
16 april 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
16 april 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 april 2020
Senast verifierad
1 april 2020
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- UDDS-Ortho-03-2020
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