Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization
Primary Purpose
Molar Incisor Hypomineralization
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
Sponsored by
About this trial
This is an interventional treatment trial for Molar Incisor Hypomineralization
Eligibility Criteria
Inclusion Criteria:
.Children with molar incisor hypo mineralization 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Direct composite restorations
preformed metal crowns
Arm Description
bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe)
preformed stainless steel crowns cemented by glass ionomer luting 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
1. Study Identification
Unique Protocol Identification Number
NCT04475419
Brief Title
Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization
Official Title
Restoration Quality in Molars Affected by Molar-incisor-hypomineralization Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
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
Restoration quality of molars affected by MIH using two different types of restorations direct composite and preformed crowns
Detailed Description
MIH or molar incisor hypomineralization is one of the difficult clinical situations to be managed by dentists the aim of this study is to specify which is the better treatment among composite restorations and preformed crowns in terms of gingival health patient satisfaction pain hypersensetivity acceptability by the patienat hypersensetivity and the need for future retreatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Molar Incisor Hypomineralization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel groups
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Direct composite restorations
Arm Type
Active Comparator
Arm Description
bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe)
Arm Title
preformed metal crowns
Arm Type
Active Comparator
Arm Description
preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
Intervention Type
Procedure
Intervention Name(s)
preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
Intervention Description
covering the affected molar with preformed metal crown cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
Primary Outcome Measure Information:
Title
pain after the restoration .Binary (yes or No)
Description
questionnaire
Time Frame
12 MONTHS
Secondary Outcome Measure Information:
Title
Acceptability of the treatment Binary (yes or No)
Description
questionnaire
Time Frame
12 months
Title
restoration quality Score index
Description
(FDI criteria; criterion marginal adaptation)
Time Frame
12 months
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 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
.Children with molar incisor hypo mineralization 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
Eman m elmasry, PHD
Phone
01001651946
Ext
12345
Email
Mahmoued_dentist3@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
osama M alshahawy, master
Phone
01001651946
Ext
12345
Email
Mahmoued_dentist3@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
manalf M elshiekh, MASTER
Organizational Affiliation
CU
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization
We'll reach out to this number within 24 hrs