- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05132764
Effect of Micro-osteo-perforations on the Rate of Alignment of Mandibular Anterior Teeth.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
MATERIAL AND METHODS:
STUDY DESIGN: Two parallel arm randomized controlled clinical trial SETTING: Orthodontics Department, Rehman College of Dentistry. DURATION OF STUDY: one year SAMPLING TECHNIQUE: non-probability consecutive sampling.
SAMPLE SELECTION:
INCLUSION CRITERIA
- Malocclusion cases with mandibular anterior segment crowding.
- Age range 13-30 years.
EXCLUSION CRITERIA:
- Missing lower anterior tooth.
- Systemic diseases/Medications affecting bone biology.
- Previous orthodontic treatment.
- Poor oral hygiene status.
- Active periodontal disease
- Syndromes. DATA COLLECTION Written informed consent from the patients will be taken after clarification of the purpose of the intervention and the associated risks and benefits. Orthodontic treatment will be started in all subjects using fixed preadusted edgewise appliance (0.022-in MBT prescription, Ortho Organizers, Inc. USA). After bonding of lower arch the patients will be randomized into control and experimental groups.
Patients will be randomly allocated, through computer generated tables in Microsoft Excel Software, into parallel groups with a 1:1 allocation ratio. Allocation will be concealed in opaque envelopes and opened only at the time of intervention.
Local anesthesia will be given in lower arch on each side approximately 1cm from labial frenum. Two points for screw insertion will be demarcated on buccal mucosa, in each interdental segment, by bleeding points using a calibrated periodontal probe. Probe tip will be inserted to the level of bone to measure the thickness of gingiva. The measurement will be added to the depth of perforation needed i-e 2 - 3 mm into the bone. First point will be marked at a distance of 3mm from free gingival margin and second point will be marked 3mm from the first one. Orthodontic miniscrew (AbsoAnchor, Korea) of 1.3 mm diameter will be used for MOPs to the depth of 2-3 mm into the buccal cortical bone. An endodontic rubber stopper will be set for required / optimal depth on miniscrew and MOPs will be performed. After the intervention, the patients will be instructed for maintaining good oral hygiene and to take analgesics, such as acetaminophen, only if necessary.
The control group will receive no MOPs at the alignment stage. Alignment will be started in both control and experimental groups using 0.012 NiTi (North American Braces, USA). Both the groups will be followed every month for maximum six months. Digital scan of lower arch will be taken on each visit. Each scan will be labelled for identification, date of scan taking and little index score .For reliability 20 randomly selected scan will be rescored for little index by the same examiner as well as another examiner after 2 weeks for intra and inter-examiner reliability.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Shahida Jehan, BDS
- Telefonnummer: 03438901267
- E-mail: shahida.jehan@rmi.edu.pk
Undersøgelse Kontakt Backup
- Navn: Sohrab Shaheed, FCPS
- Telefonnummer: 03339327608
- E-mail: sohrab.shaheed@rmi.edu.pk
Studiesteder
-
-
KPK
-
Peshawar, KPK, Pakistan, 25100
- Rekruttering
- Sohrab Shaheed
-
Kontakt:
- Sohrab Shaheed, FCPS
- Telefonnummer: 03339327608
- E-mail: sohrab.shaheed@rmi.edu.pk
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Malocclusion cases with mandibular anterior segment crowding.
- Age range 13-30 years.
Exclusion Criteria:
- Missing lower anterior tooth.
- Systemic diseases/Medications affecting bone biology.
- Previous orthodontic treatment.
- Poor oral hygiene status.
- Active periodontal disease
- Syndromes
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: MOPs group
Orthodontic treatment will be started in all subjects using fixed preadusted edgewise appliance (0.022-in MBT prescription, Ortho Organizers, Inc. USA).Local anesthesia will be given in lower arch .Two points for screw insertion will be demarcated on buccal mucosa, in each interdental segment using a calibrated periodontal probe.
Orthodontic miniscrew (AbsoAnchor, Korea) of 1.3 mm diameter will be used for MOPs to the depth of 2-3 mm into the buccal cortical bone.
An endodontic rubber stopper will be set for required / optimal depth on miniscrew and MOPs will be performed.
After the intervention, the patients will be instructed for maintaining good oral hygiene and to take analgesics, such as acetaminophen, only if necessary.
|
2 inter radicular bone microosteoperforations using temporary anchorage device tip.
|
|
Ingen indgriben: Control group
Orthodontic treatment will be started in all subjects using fixed preadusted edgewise appliance (0.022-in MBT prescription, Ortho Organizers, Inc. USA).The control group will receive no MOPs at the alignment stage.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of alignment of lower anterior teeth
Tidsramme: 6 months
|
Rate of alignment of lower anterior teeth
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
clinical crown length
Tidsramme: 6 moths
|
clinical crown length
|
6 moths
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Muhammad K Asif, PhD, Rehman Medical Institute
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- EC : 2021-06-070
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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