AzTrials
AzTrials

White Spot LesionNCT05738356

Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems

A study testing Adhesive bonding systems in people with White Spot Lesion, run by Jordan University of Science and Technology at 1 site in Jordan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The gaol of this randomized clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of white spot lesions (WSLs) during fixed orthodontic therapy in comparison with the conventional 3 step bonding system. Read more about this study

Who is it for?
Ages 17 to 25 yearsHealthy volunteers can take part
Conditions the study is for
White Spot Lesion
What is being tested?
Adhesive bonding systems
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteJordan
Study dates
10 Dec 2021to 1 Jul 2023
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 17 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy patients from both sexes aged 17 - 25 years
  • Mild-to-moderate crowding (≤5 mm)
  • Optimum oral hygiene
  • Maximum of 3 restored teeth
  • Absence of defective enamel formation in the form of hypocalcification or hypoplasia
  • No salivary gland diseases.

Who cannot join

  • Patients with poor oral hygiene
  • Heavily restored teeth
  • Sever crowding
  • Presence of systemic disease that may affect salivary glands or the ability to brush their teeth properly.

Trial locations and contacts

1 site in 1 country.

Jordan1 site

  • Postgraduate Dental Teaching Clinics/JUST

    Irbid, 22110

Other trials in Jordan

About this study

Official title: Comparison of Three Orthodontic Bonding Systems in White Spot Lesion Development: A Randomized Clinical Trial

The gaol of this randomized clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of white spot lesions (WSLs) during fixed orthodontic therapy in comparison with the conventional 3 step bonding system.

All participants will be bonded with similar fixed orthodontic appliances using each type of adhesives for the assigned group. WSLs will be monitored during the orthodontic treatment

Read the detailed description

Objectives: The objective of this clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of WSLs during fixed orthodontic therapy in comparison with the conventional 3 step bonding system.

Materials and Methods: Seventy five patients were randomly allocated into 3 groups (Group 1, conventional bonding system, n=25; Group 2, self-etch primer n=25; Group 3, primer mixed with the adhesive composite n=25). Quantitative light-induced fluorescence (QLF) was used to quantify WSL parameters. Images were captured and then analyzed before treatment; 2 months and 4 months after bond-up. Lesion area (Pixels), mean fluorescence loss (∆F) and the number of newly developed WSLs were compared within and between the 3 groups. The significance level was set at P ≤ 0.05.

Being tested
Adhesive bonding systems
Keywords
Self-etch primer, one step adhesive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adhesive bonding systemsCombination product

    Three different adhesive bonding systems were used; one system per group

Study groups in NCT05738356
Study groupRoleWhat they receive
Three-step adhesiveActive comparatorThe orthodontic appliances were bonded to the patients teeth using conventional 3 step adhesive (3M™ Transbond™ XT, 3M Unitek, United States)
Receives: Combination Product: Adhesive bonding systems
Self-etch primer adhesiveExperimentalThe orthodontic appliances were bonded to the patients teeth using self-etch primer (3M™ Transbond™ Plus, 3M Unitek, United States).
Receives: Combination Product: Adhesive bonding systems
One-step adhesive systemExperimentalThe orthodontic appliances were bonded to the patients teeth using one-step adhesive system (GC Ortho Connect™, GC Orthodontics, Germany)
Receives: Combination Product: Adhesive bonding systems

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average lesion fluorescence loss (ΔF%)

    It reflects mineral loss from tooth surface (in percent)

    Measured: 4 months

  2. surface area of WSL

    Area of mineral loss measured in pixels

    Measured: 4 months

  3. Incidence of WSL

    Number of newly developed WSLs

    Measured: 4 months

Secondary outcomes (1)

  1. Maximum lesion fluorescence loss (ΔFMAX%)

    It reflects the deepest area of the WSL (in percent)

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study start10 Dec 2021
  3. Primary completion16 Jun 2022
  4. Study completion1 Jul 2023

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05738356
Sponsor's protocol ID
JUST20220118
Status last verified
May 2024
First submitted
4 Feb 2023
Last updated
2 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be available upon request

Publications

  • Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x.

    PubMed 6758594

  • Mohammed RE, Abass S, Abubakr NH, Mohammed ZM. Comparing orthodontic bond failures of light-cured composite resin with chemical-cured composite resin: A 12-month clinical trial. Am J Orthod Dentofacial Orthop. 2016 Aug;150(2):290-4. doi: 10.1016/j.ajodo.2016.02.013.

    PubMed 27476362

  • BUONOCORE MG. A simple method of increasing the adhesion of acrylic filling materials to enamel surfaces. J Dent Res. 1955 Dec;34(6):849-53. doi: 10.1177/00220345550340060801. No abstract available.

    PubMed 13271655

  • Frazier MC, Southard TE, Doster PM. Prevention of enamel demineralization during orthodontic treatment: an in vitro study using pit and fissure sealants. Am J Orthod Dentofacial Orthop. 1996 Nov;110(5):459-65. doi: 10.1016/s0889-5406(96)70050-1.

    PubMed 8922502

  • Miller CC, Burnside G, Higham SM, Flannigan NL. Quantitative Light-induced Fluorescence-Digital as an oral hygiene evaluation tool to assess plaque accumulation and enamel demineralization in orthodontics. Angle Orthod. 2016 Nov;86(6):991-997. doi: 10.2319/092415-648.1. Epub 2016 Mar 23.

    PubMed 27007753

  • Bishara SE, Ajlouni R, Laffoon JF, Warren JJ. Comparison of shear bond strength of two self-etch primer/adhesive systems. Angle Orthod. 2006 Jan;76(1):123-6. doi: 10.1043/0003-3219(2006)076[0123:COSBSO]2.0.CO;2.

    PubMed 16448281

  • Elkalza, A., Mostafa, D. (2018). 'Laboratory evaluation of shear bond strength of three different bonding systems for orthodontic brackets', Egyptian Orthodontic Journal, 53(June 2018), pp. 55-60. doi: 10.21608/eos.2018.77121

  • Choi A, Yoo KH, Yoon SY, Park BS, Kim IR, Kim YI. Anti-Microbial and Remineralizing Properties of Self-Adhesive Orthodontic Resin Containing Mesoporous Bioactive Glass. Materials (Basel). 2021 Jun 25;14(13):3550. doi: 10.3390/ma14133550.

    PubMed 34202013

  • Bishara SE, Gordan VV, VonWald L, Olson ME. Effect of an acidic primer on shear bond strength of orthodontic brackets. Am J Orthod Dentofacial Orthop. 1998 Sep;114(3):243-7. doi: 10.1016/s0889-5406(98)70205-7.

    PubMed 9743128

  • Bishara SE, VonWald L, Laffoon JF, Warren JJ. Effect of a self-etch primer/adhesive on the shear bond strength of orthodontic brackets. Am J Orthod Dentofacial Orthop. 2001 Jun;119(6):621-4. doi: 10.1067/mod.2001.113269.

    PubMed 11395706

  • Montasser MA, El-Wassefy NA, Taha M. In vitro study of the potential protection of sound enamel against demineralization. Prog Orthod. 2015;16:12. doi: 10.1186/s40510-015-0080-2. Epub 2015 May 22.

    PubMed 26061985

  • Paschos E, Rosenbeck KA, Huth KC, Rudzki I, Wichelhaus A, Kunzelmann KH. Evaluation of the effect of bracket-periphery treatment on prevention of enamel demineralization by consecutive muCT scans. Clin Oral Investig. 2015 Jul;19(6):1519-26. doi: 10.1007/s00784-014-1351-x. Epub 2014 Nov 14.

    PubMed 25391496

  • SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

    PubMed 14158464

  • Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.

    PubMed 5237684

  • Albhaisi Z, Al-Khateeb SN, Abu Alhaija ES. Enamel demineralization during clear aligner orthodontic treatment compared with fixed appliance therapy, evaluated with quantitative light-induced fluorescence: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 May;157(5):594-601. doi: 10.1016/j.ajodo.2020.01.004.

    PubMed 32354432

Questions about this trial

What is this clinical trial studying?

A study testing Adhesive bonding systems in people with White Spot Lesion, run by Jordan University of Science and Technology at 1 site in Jordan.

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 6 inclusion and 4 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 2 May 2024. 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 Jordan. 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?

Average lesion fluorescence loss (ΔF%) (time frame: 4 months). The study lists 3 primary outcomes in all. 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 NCT05738356, which also lists 30 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 2 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in