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 III)

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.

Study Overview

• Status: Unknown
• Conditions: Molar Incisor Hypomineralization
• Intervention / Treatment: Procedure: Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • faculty of oral and dental medicine,cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Children with MIH in one fully erupted molar or more.
2. Age ranging from 7-12 years.
3. cooperative children
4. Good general health.

Exclusion Criteria:

1. patients participating in other experiments.
2. Patients with parents planning to move away within the following year.
3. Patients with only mildly affected MIH molars that do not require extensive restorative treatment.
4. MIH-affected molars that have a very poor prognosis and require extraction.
5. First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Direct composite restoration; Bulk-fill composite (Filtek bulk flow, 3M Espe ) will be used and covered using a nanohybrid copmosite (filtek XT, 3M Espe )	Procedure: Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe); Covering the affected molar with preformed metal crown cemented by glass ionomer lutting cement
ACTIVE_COMPARATOR: Preformed metal crowns; Preformed stainless-steal crowns cemented by glass ionomer lutting cement (ketac cem. 3M Espe )	Procedure: Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe); Covering the affected molar with preformed metal crown cemented by glass ionomer lutting cement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain after the restoration Binary (yes or no )	Questionnaire	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the treatment Binary (yes or no )	Questionnaire	12 month
Restoration quality score index	(FDI criteria: criterion marginal adaptation	12 month
Health-related quality of life changes by the therapies	Measured as difference in child perceptions Questionnaire CPQ 8-10/11-14)	12 month

Collaborators and Investigators

• Sponsor: Nada Mahmoud Abd El-Azim Mohamed

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 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2020
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: November 9, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (ACTUAL): December 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: MIH
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Tooth Abnormalities; Dental Enamel Hypoplasia
• Other Study ID Numbers: ttt of teeth with MIH part III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No