- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04654858
Restoration of Permanent Molars Affected With (MIH) Using Composite Restorations or Preformed Metal Crowns
Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial (Part II)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Molar incisor hypomineralization can represent a serious and challenging clinical management problem. Children with MIH require higher levels of treatment needs and demonstrate considerable management problems.
For most severely affected MIH molars, direct esthetic restorative materials or preformed metal crowns will be the treatments to choose between. A number of aspects which could support decision-making, however, are not clearly demarcated. First and foremost, it is not clear if both treatments are similarly acceptable for patients and providers.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: amal el kot, bachelor
- Phone Number: 01011730863
- Email: amal.elkot@dentistry.cu.edu.eg
Study Contact Backup
- Name: Prof. Dr. Eman Elmasry, Prof. Dr
Study Locations
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Cairo, Egypt
- Faculty of Oral and Dental Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children with MIH in one fully erupted molar or more.
- Age ranging from 7-12 years.
- cooperative children
- Good general health.
Exclusion Criteria:
- patients participating in other experiments.
- Patients with parents planning to move away within the following year.
- Patients with only mildly affected MIH molars that do not require extensive restorative treatment.
- MIH-affected molars that have a very poor prognosis and require extraction.
First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Direct composite restorations
bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used after infiltration or block anaesthesia for affected molar, following by carious tissue removal.
Marginal bevelling of enamel will be performed.
A universal adhesive (Scotchbond Universal, 3M Espe) will be placed after selective enamel etching A bulk-fill composite will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe).
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bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used aftar infiltration or block anaesthesia for affected molar,following by carious tissue removal.
Marginal bevelling of enamel will be performed.
A universal adhesive (Scotchbond Universal, 3M Espe) will be placed after selective enamel etching A bulk-fill composite will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe).
Other Names:
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Active Comparator: Performed metal crowns
PMCs (3M Espe, Seefeld, Germany) will be placed after infiltration or block anaesthesia for affected molar, followed by removal of carious dentin and enamel, Tooth preparation for fitting the crown, The correct size of crown will be chosen, and then Cemented with glass ionomer luting cement (KetacCem, 3M Espe).
|
bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used aftar infiltration or block anaesthesia for affected molar,following by carious tissue removal.
Marginal bevelling of enamel will be performed.
A universal adhesive (Scotchbond Universal, 3M Espe) will be placed after selective enamel etching A bulk-fill composite will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hypersensitivity
Time Frame: 12 month
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Questioning the patient and/or the parent (Clemenus et al,2017) Binary (yes, no)
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12 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of the treatment
Time Frame: 12 month
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Questioning the children or parents about accepting the treatment Binary (Yes or No)
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12 month
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- • • Alanzi A, Faridoun A, Kavvadia K, Ghanim A. 2018. Dentists' perception, knowledge, and clinical management of molar-incisor-hypomineralisation in kuwait: A cross-sectional study. BMC oral health. 18(1):34. • Bakkal M, Abbasoglu Z, Kargul B. 2017. The effect of casein phosphopeptide-amorphous calcium phosphate on molar-incisor hypomineralisation: A pilot study. Oral health & preventive dentistry. 15(2):163-167. • Baroni C, Marchionni S. 2011. Mih supplementation strategies: Prospective clinical and laboratory trial. Journal of dental research. 90(3):371-376. • Bekes K, Heinzelmann K, Lettner S, Schaller HG. 2016. Efficacy of desensitizing products containing 8% arginine and calcium carbonate for hypersensitivity relief in mih-affected molars: An 8-week clinical study. Clinical oral investigations. • Bekes K, Steffen R. 2016. Das würzburger mih - konzept: Teil 1. Der mih - treatment need index (mih - tni). Ein neuer index zur befunderhebung und therapieplanung bei patienten mit molaren - inzisiven hypomineralisation Oralprophylaxe & Kinderzahnheilkunde. 38(4):165-170. • Briggs A, Sculpher M. 1997. Commentary: Markov models of medical prognosis. BMJ. 314 (7077):345-345.Briggs AH, O'Brien BJ, Blackhouse G. 2002. Thinking outside the box: Recent advances in the analysis and presentation of uncertainty in cost-effectiveness studies. Annual Review of Public Health. 23(1):377-401. • Byford, S., Knapp, M., Greenshields, J., Byford, S., Knapp, M., Greenshields, J., et al (2003) Cost-effectiveness of brief cognitive behaviour therapy Cost-effectiveness of brief cognitive behaviour therapy versus treatment as usual in recurrent deliberate self- versus treatment as usual in recurrent deliberate selfharm: a rational decision making approach. harm: a rational decision making approach. Psychological Psychological MedicineMedicine, 33, 977 • Cuzick J. 2005. Rank regression. Encyclopedia of biostatistics vol 6. Wiley and Sons. de Souza JF, Fragelli CB, Jeremias F, Paschoal MAB, Santos-Pinto L, de Cassia Loiola Cordeiro R. 2017. • Eighteen-month clinical performance of composite resin restorations with two different adhesive systems for molars affected by molar incisor hypomineralization. Clinical oral investigations. 21(5):1725-1733. • Dworkin SL. 2012. Sample size policy for qualitative studies using in-depth interviews. Archives of sexual behavior. 41(6):1319-1320. • Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA. 2016. Consort 2010 statement: Extension to randomised pilot and feasibility trials. Bmj. 355:i5239
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- treatment of teeth with MIH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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