- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04940351
Evaluation of the Effectiveness of Piezocision and Micro-osteoperforation in Alleviating Mandibular Anterior Crowding
9. januar 2022 oppdatert av: Postgraduate Institute of Dental Sciences Rohtak
Comparative Evaluation of the Effectiveness of Piezocision and Micro-osteoperforation in Alleviating Mandibular Anterior Crowding: A Randomized Clinical Trial
In recent times, many patients want their treatment duration to be reduced, because lengthy orthodontic treatment duration is associated with negative sequelae such as discomfort, pain, white spot lesions, and decreased patient's compliance.
Several techniques have been employed in an attempt to accelerate the tooth movement and shorten the lengthy orthodontic treatment duration.
So, this study will investigate the effectiveness of minimal invasive technique like piezocision and microosteoperforation in alleviating mandibular anterior crowding which is one of the common malocclusiom and provide scientific knowledge regarding which minimal invasive tecnique will relieve the crowding faster.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
Records will be taken from patients who are meeting selection criteria and then analysis of record will be done to attain a proper diagnosis and treatment plan.
Afterthat, those patients will be referred to oral surgery department for extraction of first premolar.
After healing, orthodontic treatment will be started with bonding of preadjusted MBT 0.022" slot straight wire appliance(Patient will be instructed to report immediately in case of breakage of appliance), after that, randomisation and allocation of two groups will be done and on the day of initial aligning archwire placement i.e., 0.014" NiTi, active interventions(piezocision and micro-osteoperforations) will be done for each group and then levelling and alignment will be continued with the following arch wire sequence 0.016" , 0.016" x 0.022" and 0.017" x 0.025" NiTi.
Levelling and alignment will be considered finished when 0.017x0.025"
NiTi archwire will be engaged passively in the brackets.
Records i.e,.
mandibular study models will be taken on the day of surgical procedure before surgery (T0) and then after every 4th week i.e., 4th week(T1), 8th week(T2), 12th week(T3), 16th week(T4).
Following this, data collection and interpretation of results will be done.
And also, CBCT will be taken at post levelling and alignment with 0.017" x 0.025" arch wire to assess the root resorption and marginal alveolar bone loss.
Studietype
Intervensjonell
Registrering (Forventet)
36
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: MANISHA KAMAL KUKREJA, MDS
- Telefonnummer: 9215650617
- E-post: mk3pgids@gmail.com
Studiesteder
-
-
Haryana
-
Rohtak, Haryana, India, 124001
- Rekruttering
- Post Graduate Institute of Dental Sciences
-
Ta kontakt med:
- MANISHA KAMAL KUKREJA, MDS
- Telefonnummer: 9215650617
- E-post: mk3pgids@gmail.com
-
-
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
16 år til 25 år (Barn, Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
Patient satisfying the following criteria will be included in this clinical study:
- Patients with age between 16-25 years
- Patients with either Angle's class I or class II malocclusion with moderate crowding in the anterior mandible(LII- 4-6mm) who requires extraction in the lower arch (tooth-size-arch-length discrepancy>5 mm)
- Permanent dentition
- Existence of all tooth in the mandibular arch (except third molars which may or may not be present)
- Good oral hygiene and periodontal health
- No smoking habit.
Exclusion Criteria:
- medical conditions that would affect tooth movement (corticosteroid treatments, NSAIDs consumption, bisphosphonates, hyperparathyroidism, osteoporosis, uncontrolled diabetes)
- Contraindication to oral surgery (medical, social, psychological)
- Missing tooth in the mandibular arch
- Presence of primary or supernumerary tooth in mandibular arch
- Previous orthodontic treatment
- Poor oral hygiene and current periodontal disease
- Smoking habit.
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: GROUP - A: PIEZOCISION GROUP
This group will receive piezocision using piezotome inbetween the roots of mandibular anteriors after the placement of initial arch wire.
|
This group will receive piezocisions after placement of initial arch wire, in between the roots of mandibular anteriors (in a vertical line) i.e., between mandibular canine and lateral incisors bilaterally, lateral incisors and central incisors bilaterally and between two cental incisors with the help of piezotome.
These piezocisions will be performed on the labial cortical bone only, 4mm below the interdental papilla under 2% lidocaine with 1:100,000 epinephrine and with standard asepsis, and gingival overlying will be incised first with blade number 15 in a Bard Parker handle.
A piezosurgical microsaw with piezosurgical drill will be placed over that incision with irrigation.
Then, vertical 5- to 8-mm and 3mm deep corticotomies will be perform using periapical radiographs as a guide to avoid penetrating into the adjacent roots.
No subsequent sutures required.
|
Eksperimentell: GROUP- B: MICRO-OSTEOPERFORATION GROUP
This group will receive Micro-Osteoperforation using orthodontic mini-implants and mini-implant screw driver after the placement of initial arch wire.
|
This group will receive MOPs after initial arch wire placement.
These MOPs will be performed under local anesthesia with standard asepsis, using a self drilling 1.6mm x 8mm orthodontic mini-implants and mini-implant screw driver and no flap will be raised.
MOP's will be placed on five sites i.e., interproximally between mandibular canine and lateral incisors bilaterally, central incisor and lateral incisor bilaterally and between two central incisors.
Each site will receive two MOP's, first 2mm apical to alveolar crest and second 2mm below the first in a vertical line and 2mm deep into the bone.
Then the mini-implant will be removed by rotating the screw driver anticlockwise and pressure will be applied to achieve hemostasis.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Amount of Crowding Relieved
Tidsramme: 4 weeks
|
Measured with Little Irregularity index using Digital caliper
|
4 weeks
|
Amount of Crowding Relieved
Tidsramme: 8 weeks
|
Measured with Little Irregularity index using Digital caliper
|
8 weeks
|
Amount of Crowding Relieved
Tidsramme: 12 weeks
|
Measured with Little Irregularity index using Digital caliper
|
12 weeks
|
Amount of Crowding Relieved
Tidsramme: 16 weeks
|
Measured with Little Irregularity index using Digital caliper
|
16 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Overall Alignment Time
Tidsramme: 16 weeks
|
Time taken to align the mandibular anteriors calculated in days
|
16 weeks
|
Root resorption of mandibular anteriors
Tidsramme: 16 weeks
|
Root length of mandibular anteriors measured before and after alignment using CBCT
|
16 weeks
|
Marginal Alveolar Bone Loss
Tidsramme: 16 weeks
|
Alveolar bone length measured before and after alignment using CBCT
|
16 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
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. juni 2021
Primær fullføring (Forventet)
1. april 2022
Studiet fullført (Forventet)
1. juli 2022
Datoer for studieregistrering
Først innsendt
17. juni 2021
Først innsendt som oppfylte QC-kriteriene
17. juni 2021
Først lagt ut (Faktiske)
25. juni 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. januar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. januar 2022
Sist bekreftet
1. januar 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- ANANDA RAJ S PGIDS/BHRC/21/19
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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