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Restoration of Permanent Molars Affected With (MIH) Using Composite Restorations or Preformed Metal Crowns

Primary Purpose

Molar Incisor Hypomineralization

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)
Sponsored by
Nada Mahmoud Abd El-Azim Mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization focused on measuring MIH

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of oral and dental medicine,Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Direct composite restoration

Preformed metal crowns

Arm Description

Bulk-fill composite (Filtek bulk flow, 3M Espe ) will be used and covered using a nanohybrid copmosite (filtek XT, 3M Espe )

Preformed stainless-steal crowns cemented by glass ionomer lutting cement (ketac cem. 3M Espe )

Outcomes

Primary Outcome Measures

Pain after the restoration Binary (yes or no )
Questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
November 9, 2020
Last Updated
December 1, 2020
Sponsor
Nada Mahmoud Abd El-Azim Mohamed
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1. Study Identification

Unique Protocol Identification Number
NCT04658602
Brief Title
Restoration of Permanent Molars Affected With (MIH) Using Composite Restorations or Preformed Metal Crowns
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nada Mahmoud Abd El-Azim Mohamed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar Incisor Hypomineralization
Keywords
MIH

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel groups
Masking
InvestigatorOutcomes Assessor
Masking Description
Quadruple ( Participant, Care Provider, Investigator, Outcomes Assessor ) Blinding to the child participants and legal guardian of each participating child, operator, outcome assessor and statistician.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Direct composite restoration
Arm Type
Active Comparator
Arm Description
Bulk-fill composite (Filtek bulk flow, 3M Espe ) will be used and covered using a nanohybrid copmosite (filtek XT, 3M Espe )
Arm Title
Preformed metal crowns
Arm Type
Active Comparator
Arm Description
Preformed stainless-steal crowns cemented by glass ionomer lutting cement (ketac cem. 3M Espe )
Intervention Type
Procedure
Intervention Name(s)
Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)
Intervention Description
Covering the affected molar with preformed metal crown cemented by glass ionomer lutting cement
Primary Outcome Measure Information:
Title
Pain after the restoration Binary (yes or no )
Description
Questionnaire
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Acceptability of the treatment Binary (yes or no )
Description
Questionnaire
Time Frame
12 month
Title
Restoration quality score index
Description
(FDI criteria: criterion marginal adaptation
Time Frame
12 month
Title
Health-related quality of life changes by the therapies
Description
Measured as difference in child perceptions Questionnaire CPQ 8-10/11-14)
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nada Mahmoud Abd el-azim Mohamed, Bachelor
Phone
+201126696236
Email
nada.abdelazim@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Prof.Dr.eman Elmasry, Prof.Dr.
Facility Information:
Facility Name
Faculty of oral and dental medicine,Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
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Restoration of Permanent Molars Affected With (MIH) Using Composite Restorations or Preformed Metal Crowns

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