Evaluation of the Levels of Pain and Discomfort Between Two Methods of Leveling and Alignment
15. april 2020 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
26
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Damascus, Den syriske arabiske republikk, 00963
- Orthodontic Department, University of Damascus Dental School
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 24 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Corticision
Patients will undergo a corticision procedure in order to accelerate tooth movement
|
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
|
|
Aktiv komparator: Traditional treatment
Patients will undergo traditional orthodontic treatment without any surgical intervention.
|
No surgical intervention will be used, just normal orthodontic sequence of procedures.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in the Perception of Pain
Tidsramme: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
|
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.
|
At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
|
|
Change in the Perception of Discomfort
Tidsramme: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
|
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.
|
At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
|
|
Change in the Perception of Swelling
Tidsramme: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
|
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
|
At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
|
|
Change in the Levels of Difficulties in Mastication
Tidsramme: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
|
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.
|
At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
|
|
Analgesic Consumption
Tidsramme: 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)
|
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.
|
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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patients' satisfaction
Tidsramme: At the end of leveling and alignment which is expected to occur within 4 to 6 months
|
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.
|
At the end of leveling and alignment which is expected to occur within 4 to 6 months
|
|
Ease of the procedure
Tidsramme: At the end of leveling and alignment which is expected to occur within 4 to 6 months
|
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.
|
At the end of leveling and alignment which is expected to occur within 4 to 6 months
|
|
The possibility of repeating the procedure
Tidsramme: At the end of leveling and alignment which is expected to occur within 4 to 6 months
|
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).
|
At the end of leveling and alignment which is expected to occur within 4 to 6 months
|
|
Recommendation to a friend
Tidsramme: At the end of leveling and alignment which is expected to occur within 4 to 6 months
|
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).
|
At the end of leveling and alignment which is expected to occur within 4 to 6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: 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
- Studieleder: Mohammad Y Hajeer, DDS MSc PhD, Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. mars 2017
Primær fullføring (Faktiske)
15. september 2018
Studiet fullført (Faktiske)
15. februar 2019
Datoer for studieregistrering
Først innsendt
13. april 2020
Først innsendt som oppfylte QC-kriteriene
15. april 2020
Først lagt ut (Faktiske)
16. april 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. april 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. april 2020
Sist bekreftet
1. april 2020
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- UDDS-Ortho-03-2020
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .