Orthodontic Appliance ComplicationNCT04606043
Evaluation of the Sandblasting on the Rebonding Strength
A study testing Sandblasting and Acid Etching in people with Orthodontic Appliance Complication, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Sandblasting and Acid Etching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSyria
- Study dates
- 20 Jun 2011to 15 Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- any type of pervious orthodontic therapy
- any need for ortho-surgical treatment or teeth extraction.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, University of Aleppo Dental School
Aleppo, Al88 74TR
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Sandblasting, Acid Etching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SandblastingProcedure or surgery
Sandblasting will be applied onto the vestibular surfaces of the teeth before applying the etchant.
Acid EtchingProcedure or surgery
Only acid etching will be applied onto the vestibular surfaces of the teeth before rebonding
| Study group | Role | What they receive |
|---|---|---|
| Sandblasting | Experimental | The enamel surfaces will be subjected to sandblasting prior to acid etching Receives: Procedure: Sandblasting |
| Acid Etching Alone | Active comparator | Acid etching will be applied alone before the rebounding procedures Receives: Procedure: Acid Etching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bonding Failure Rate
Number of brackets loosing their bond to the enamel during the observation period divided by the total number of braces being applied.
Measured: After six month exactly of bonding the brackets onto the surfaces of the teeth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start20 Jun 2011
- Primary completion10 May 2012
- Study completion15 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Split-mouth design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmad Rami Dirie, DDS MSc, Principal investigator, Specialist and Clinical Lecturer, Department of Orthodontics, University of AleppoHeba M. Al-Ibrahim, DDS, Principal investigator, MSc student in Orthodontics, University of DamascusJamal Dabbas, DDS MSc PhD, Study director, Professor of Orthodontics, Department of Orthodontics, University of AleppoMohammad Y Hajeer, DDS MSc PhD, Study director, Professor of Orthodontics, Department of Orthodontics, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04606043
- Sponsor's protocol ID
- UADS-2020-01
- Status last verified
- Oct 2020
- First submitted
- 25 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8540484Bishara 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.
PubMed 12045771Faust 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.
PubMed 354405Mizrahi 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.
PubMed 7049010Dirie 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.
PubMed 33422476
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Enamel Surface Treatment Using Sandblasting on the Bond Strength in the Rebonding Process: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04606043
- Acronym / sponsor ID
- UADS-2020-01
- Conditions
- Orthodontic Appliance Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 20 Jun 2011 (actual)
- Primary completion
- 10 May 2012 (actual)
- Study completion
- 15 Jun 2012 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Split-mouth design
| Arm | Type | Receives |
|---|---|---|
| Sandblasting | Experimental | Procedure: SandblastingThe enamel surfaces will be subjected to sandblasting prior to acid etching |
| Acid Etching Alone | Active comparator | Procedure: Acid EtchingAcid etching will be applied alone before the rebounding procedures |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- any type of pervious orthodontic therapy
- any need for ortho-surgical treatment or teeth extraction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SandblastingSandblasting will be applied onto the vestibular surfaces of the teeth before applying the etchant. | Procedure or surgery | Sandblasting |
| Acid EtchingOnly acid etching will be applied onto the vestibular surfaces of the teeth before rebonding | Procedure or surgery | Acid Etching Alone |
Primary outcome
Bonding Failure Rate
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Background: PubMed 8540484Egan 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.
- Background: PubMed 12045771Bishara 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.
- Background: PubMed 354405Faust 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.
- Background: PubMed 7049010Mizrahi 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.
- Derived from this study: PubMed 33422476Dirie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad Rami Dirie, DDS MSc principal investigator
Specialist and Clinical Lecturer, Department of Orthodontics, University of Aleppo
Heba M. Al-Ibrahim, DDS principal investigator
MSc student in Orthodontics, University of Damascus
Jamal Dabbas, DDS MSc PhD study director
Professor of Orthodontics, Department of Orthodontics, University of Aleppo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sandblasting and Acid Etching in people with Orthodontic Appliance Complication, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bonding Failure Rate (time frame: After six month exactly of bonding the brackets onto the surfaces of the teeth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04606043, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.