- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04606043
Evaluation of the Sandblasting on the Rebonding Strength
Evaluation of the Effectiveness of Enamel Surface Treatment Using Sandblasting on the Bond Strength in the Rebonding Process: a Randomized Controlled Trial
Patients at the Orthodontic Department of University of Aleppo Dental School will be selected if they meet the inclusion criteria then fixed orthodontic treatment with 0.018-inch slot MBT appliances will be applied for those patients.
The aim of this study is to compare Two rebonding procedures by applying a split-mouth design. The clinical failure rates of the two rebonding procedures will be evaluated.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The sample of this study will be chosen after examination of patients referred to the Department of Orthodontics at the University of Aleppo Dental School then subjects who meet the inclusion criteria will be included in this trial.
An information sheet will be given to each possible candidate. Then consent forms will be obtained.
All patients will receive both rebonding procedures by applying split-mouth design. Each patient will be asked to select an opaque sealed envelope from a box with 20 ones. Ten envelopes will Include instructions for applying sandblasting prior to acid-etching on the right upper premolars and acid-etching alone on the left upper premolars. In contrast, the other ten envelopes will include opposite instructions.
A total sample of 80 premolars will be obtained to study the clinical failure rates of the two rebonding procedures.
The 80 premolars will be randomly divided into two groups:
- The first group in which the enamel will be prepared using sandblasting prior to acid-etching.
- The second group in which the enamel will be prepared using acid-etching alone.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Aleppo, Syrien Arabiske Republik, Al88 74TR
- Department of Orthodontics, University of Aleppo Dental School
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- good general health and oral hygiene
- willing and able to comply with the trial procedures
- No crossbite, scissor bite, or occlusal interferences with the bonded/rebonded brackets in the premolars region (to prevent any potential early bond failure)
- no craniofacial anomalies.
Exclusion Criteria:
- any type of pervious orthodontic therapy
- any need for ortho-surgical treatment or teeth extraction.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Sandblasting
The enamel surfaces will be subjected to sandblasting prior to acid etching
|
Sandblasting will be applied onto the vestibular surfaces of the teeth before applying the etchant.
|
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Aktiv komparator: Acid Etching Alone
Acid etching will be applied alone before the rebounding procedures
|
Only acid etching will be applied onto the vestibular surfaces of the teeth before rebonding
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Bonding Failure Rate
Tidsramme: After six month exactly of bonding the brackets onto the surfaces of the teeth
|
Number of brackets loosing their bond to the enamel during the observation period divided by the total number of braces being applied.
|
After six month exactly of bonding the brackets onto the surfaces of the teeth
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ahmad Rami Dirie, DDS MSc, Specialist and Clinical Lecturer, Department of Orthodontics, University of Aleppo
- Ledende efterforsker: Heba M. Al-Ibrahim, DDS, MSc student in Orthodontics, University of Damascus
- Studieleder: Jamal Dabbas, DDS MSc PhD, Professor of Orthodontics, Department of Orthodontics, University of Aleppo
- Studieleder: Mohammad Y Hajeer, DDS MSc PhD, Professor of Orthodontics, Department of Orthodontics, University of Damascus
Publikationer og nyttige links
Generelle publikationer
- Egan FR, Alexander SA, Cartwright GE. Bond strength of rebonded orthodontic brackets. Am J Orthod Dentofacial Orthop. 1996 Jan;109(1):64-70. doi: 10.1016/s0889-5406(96)70164-6.
- Bishara SE, Laffoon JF, Vonwald L, Warren JJ. The effect of repeated bonding on the shear bond strength of different orthodontic adhesives. Am J Orthod Dentofacial Orthop. 2002 May;121(5):521-5. doi: 10.1067/mod.2002.123042.
- Faust JB, Grego GN, Fan PL, Powers JM. Penetration coefficient, tensile strength, and bond strength of thirteen direct bonding orthodontic cements. Am J Orthod. 1978 May;73(5):512-25. doi: 10.1016/0002-9416(78)90241-5. No abstract available.
- Mizrahi E. Success and failure of banding and bonding. A clinical study. Angle Orthod. 1982 Apr;52(2):113-7. doi: 10.1043/0003-3219(1982)0522.0.CO;2.
- Dirie AR, Hajeer MY, Dabbas J, Al-Ibrahim HM. Evaluation of sandblasting with acid etching versus acid etching alone in the preparation of enamel for rebonding orthodontic brackets: An in vitro study and a randomized controlled trial. J World Fed Orthod. 2021 Mar;10(1):3-8. doi: 10.1016/j.ejwf.2020.12.001. Epub 2021 Jan 7.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
- UADS-2020-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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