Restoration of Permanent Molars Affected With (MIH) Using Composite Restorations or Preformed Metal Crowns
1 other identifier
interventional
30
1 country
1
Brief Summary
The aim of this study is to compare clinical outcome of using direct esthetic composite restorations in managing MIH cases and the use of preformed metal crowns.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedDecember 8, 2020
December 1, 2020
10 months
November 9, 2020
December 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain after the restoration Binary (yes or no )
Questionnaire
12 month
Secondary Outcomes (3)
Acceptability of the treatment Binary (yes or no )
12 month
Restoration quality score index
12 month
Health-related quality of life changes by the therapies
12 month
Study Arms (2)
Direct composite restoration
ACTIVE COMPARATORBulk-fill composite (Filtek bulk flow, 3M Espe ) will be used and covered using a nanohybrid copmosite (filtek XT, 3M Espe )
Preformed metal crowns
ACTIVE COMPARATORPreformed stainless-steal crowns cemented by glass ionomer lutting cement (ketac cem. 3M Espe )
Interventions
Covering the affected molar with preformed metal crown cemented by glass ionomer lutting cement
Eligibility Criteria
You may qualify if:
- Children with MIH in one fully erupted molar or more.
- Age ranging from 7-12 years.
- cooperative children
- Good general health.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of oral and dental medicine,Cairo University
Cairo, Egypt
Related Publications (1)
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 Elhennawy K, Jost-Brinkmann PG, Manton DJ, Paris S, Schwendicke F. 2017a. Managing molars with severe molar-incisor hypomineralization: A cost-effectiveness analysis within german healthcare. Journal of dentistry. 63:65-71. Elhennawy K, Manton DJ, Crombie F, Zaslansky P, Radlanski RJ, Jost-Brinkmann PG, Schwendicke F. 2017b. Structural, mechanical and chemical evaluation of molar-incisor hypomineralization-affected enamel: A systematic review. Archives of oral biology. 83:272-281. Elhennawy K, Schwendicke F. 2016. Managing molar-incisor hypomineralization: A systematic review. Journal of dentistry. 55:16-24. Foster Page LA, Thomson WM, Jokovic A, Locker D. 2005. Validation of the child perceptions questionnaire (cpq 11-14). Journal of dental research. 84(7):649-652. Fragelli CM, Souza JF, Jeremias F, Cordeiro Rde C, Santos-Pinto L. 2015. Molar incisor hypomineralization (mih): Conservative treatment management to restore affected teeth. Brazilian oral research. 29. Fragelli CMB, Souza JF, Bussaneli DG, Jeremias F, Santos-Pinto LD, Cordeiro RCL. 2017. Survival of sealants in molars affected by molar-incisor hypomineralization: 18-month follow-up. Brazilian oral research. 31:e30. Gaardmand E, Poulsen S, Haubek D. 2013. Pilot study of minimally invasive cast adhesive copings for early restoration of hypomineralised first permanent molars with post-eruptive breakdown. European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry. 14(1):35-39. Gambetta-Tessini K, Marino R, Ghanim A, Calache H, Manton DJ. 2016. Knowledge, experience and perceptions regarding molar-incisor hypomineralisation (mih) amongst australian and chilean public oral health care practitioners. BMC oral health. 16(1):75.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Prof.Dr.eman Elmasry, Prof.Dr.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Quadruple ( Participant, Care Provider, Investigator, Outcomes Assessor ) Blinding to the child participants and legal guardian of each participating child, operator, outcome assessor and statistician.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctor/Dentist
Study Record Dates
First Submitted
November 9, 2020
First Posted
December 8, 2020
Study Start
December 1, 2020
Primary Completion
October 1, 2021
Study Completion
December 1, 2021
Last Updated
December 8, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share