Clinical trial NCT04606043: Evaluation of the Sandblasting on the Rebonding Strength
Official title: Evaluation of the Effectiveness of Enamel Surface Treatment Using Sandblasting on the Bond Strength in the Rebonding Process: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance Complication
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Split-mouth design
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. good general health and oral hygiene
2. willing and able to comply with the trial procedures
3. No crossbite, scissor bite, or occlusal interferences with the bonded/rebonded brackets in the premolars region (to prevent any potential early bond failure)
4. no craniofacial anomalies.

Exclusion Criteria:

1. any type of pervious orthodontic therapy
2. any need for ortho-surgical treatment or teeth extraction.

Primary outcomes:
measure: Bonding Failure Rate
timeFrame: After six month exactly of bonding the brackets onto the surfaces of the teeth
Secondary outcomes:
Other outcomes:
Locations:
city: Aleppo
country: Syrian Arab Republic
facility: Department of Orthodontics, University of Aleppo Dental School
Study officials:
affiliation: Specialist and Clinical Lecturer, Department of Orthodontics, University of Aleppo
name: Ahmad Rami Dirie, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: MSc student in Orthodontics, University of Damascus
name: Heba M. Al-Ibrahim, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Orthodontics, Department of Orthodontics, University of Aleppo
name: Jamal Dabbas, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Professor of Orthodontics, Department of Orthodontics, University of Damascus
name: Mohammad Y Hajeer, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.