Evaluation Direct and Indirect Composite Restoration in Hypomineralization Molars.
Primary Purpose
Dental Enamel Hypoplasia, Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Direct restoration
Indirect restoration
Sponsored by
About this trial
This is an interventional treatment trial for Dental Enamel Hypoplasia focused on measuring MIH, Direct composite, Indirect composite, Permanent molars
Eligibility Criteria
Inclusion Criteria:
- Age between 8 and 12 years.
- Definitely positive or positive ratings of Frank scale.
- The first permanent molars must achieve the following criteria: The molar must be suffering from severe demineralization and it must be restorable with composite.
- caries lesions include the occlusal surface and should not extend more than thirds of the thickness of dentin
- Absence clinical and radiographic signs which indicate pulp necrosis
Exclusion Criteria:
- Systematic or mental disorders.
- Definitely negative or negative ratings of Frankel scale
- Existence periapical translucence
- Existence external or internal abnormal absorption
- Existence swelling or fistula
- Sensitivity to percussion
- Existence of spontaneous or stimulant pain
Sites / Locations
- Damascus University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Direct composite in hypomineraliztion molars.
Indirect composite in hypomineraliztion molars.
Arm Description
Outcomes
Primary Outcome Measures
Clinical evaluation of teeth restored by direct composite.
Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following:
Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).
Clinical evaluation of teeth restored by direct composite.
Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following:
Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).
Clinical evaluation of teeth restored by direct composite.
Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following:
Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).
Clinical evaluation of teeth restored by indirect composite.
Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following:
Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).
Clinical evaluation of teeth restored by indirect composite.
Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following:
Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).
Clinical evaluation of teeth restored by indirect composite.
Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following:
Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05299489
Brief Title
Evaluation Direct and Indirect Composite Restoration in Hypomineralization Molars.
Official Title
Clinical Randomized Controlled Trial To Compare Direct and Indirect Composite Restoration in Children With Molar Incisor Hypomineralization Patients (MIH)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
December 25, 2021 (Actual)
Study Completion Date
February 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus 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
The aim of this study is to evaluate the effectiveness of direct and Indirect Composite Restoration in Children With Molar Incisor Hypomineralization Patients (MIH) and following up after 3 , 6 , 12 months (Clinically):
Group A ( Control group ): Hypomineralization molars were restored by direct composite.
Group B ( Experimental group ): Hypomineralization molars were restored by indirect composite.
Detailed Description
Pediatric dentists face a high prevalence of MIH ranging from 3 to 40%, so it is relatively common condition that would cause treatment challenges due to severe sensitivity, breakdown of the occlusal surface, difficulty anesthesia and relatively high failure of restorations as a result of marginal breakdown of restorations.
There are many treatment options available to restore these teeth. In mild and moderate cases, they are restored using direct composite resin. In cases where teeth are severely affected, the treatment is more complicated, including stainless steel crowns and different types of full or partial indirect crowns.
Direct composite resin restorations are the treatment option in the majority of clinical cases, but in severe cases, the results of treatment are often unsatisfactory.
Indirect composite restorations are an aesthetic alternative to cast metal inlays and stainless steel crowns with minimal microleakage.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Enamel Hypoplasia, Dental Caries
Keywords
MIH, Direct composite, Indirect composite, Permanent molars
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Split mouth design
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Direct composite in hypomineraliztion molars.
Arm Type
Experimental
Arm Title
Indirect composite in hypomineraliztion molars.
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Direct restoration
Intervention Description
Local anesthesia was achieved and the tooth were isolated using a rubber dam. Then, the entire caries and hypomineralized enamel were removed using diamond burs and removal the affected dentine caries by slow speed handpiece, the final preparation must be on intact enamel. The molars were wiped using 5.25% sodium hypochlorite followed by rinsing with water, etching using 37% phosphoric acid The surface of the restoration, bonding, applying composite and assessment of occlusion.
Intervention Type
Other
Intervention Name(s)
Indirect restoration
Intervention Description
Local anesthesia was achieved and the tooth were isolated using a rubber dam. Then, the entire caries and hypomineralized enamel were removed using diamond burs and removal the affected dentine caries by slow speed handpiece, the final preparation must be on intact enamel. Preparation walls were vertical according to the longitudinal axis of the tooth and the occlusal depth 2 mm. The impressions were taken for both jaws and the bite were recorded for the using red wax. The cavity in example were painted with insulating material. Indirect composite resin were applied, finishined and polished.
Cementation:
Tooth surface: The molars were wiped using 5.25% sodium hypochlorite followed by rinsing with water, etching using 37% phosphoric acid The surface of the restoration: application of silane coupling agent to enhance the formation of resin tags.
Dual cure resin cement was used for final cementation followed by an assessment of occlusion.
Primary Outcome Measure Information:
Title
Clinical evaluation of teeth restored by direct composite.
Description
Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following:
Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).
Time Frame
3 months after applying the restoration
Title
Clinical evaluation of teeth restored by direct composite.
Description
Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following:
Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).
Time Frame
6 months after applying the restoration
Title
Clinical evaluation of teeth restored by direct composite.
Description
Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following:
Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).
Time Frame
12 months after applying the restoration
Title
Clinical evaluation of teeth restored by indirect composite.
Description
Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following:
Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).
Time Frame
3 months after applying the restoration
Title
Clinical evaluation of teeth restored by indirect composite.
Description
Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following:
Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).
Time Frame
6 months after applying the restoration
Title
Clinical evaluation of teeth restored by indirect composite.
Description
Clinical evaluation of restored tooth was assessed according to USPHS criteria (Alpha, Bravo, Charlie) as following:
Marginal Adaptation: (No crevice), (Crevice), (Fractured, missing). Marginal Discoloration: (no discoloration), (discoloration but has not penetrated along the margin), (discoloration has present along the). Secondary caries: (No evidence of caries), (Evidence of caries). Color Matching: (100% color match), (Slight mismatched), (Total mismatched). Anatomic Form: (anatomic form), (teeth partially degraded but clinically acceptable), (partially degraded but need to be replaced). Postoperative Sensitivity: (no Postoperative sensitivity), (slight sensitivity), (sever sensitivity).Retention: (no loss) (fracture or loss). Surface Texture: (no defect), (minimal defect), (severed defect).
Time Frame
12 months after applying the restoration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 8 and 12 years.
Definitely positive or positive ratings of Frank scale.
The first permanent molars must achieve the following criteria: The molar must be suffering from severe demineralization and it must be restorable with composite.
caries lesions include the occlusal surface and should not extend more than thirds of the thickness of dentin
Absence clinical and radiographic signs which indicate pulp necrosis
Exclusion Criteria:
Systematic or mental disorders.
Definitely negative or negative ratings of Frankel scale
Existence periapical translucence
Existence external or internal abnormal absorption
Existence swelling or fistula
Sensitivity to percussion
Existence of spontaneous or stimulant pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdulrhman S Hakmi
Organizational Affiliation
MSc student in Pedodontics, University of Damascus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mayssoon Dashash, Phd
Organizational Affiliation
Professor of Pedodontics, Department of Pedodontics, University of Damascus
Official's Role
Study Director
Facility Information:
Facility Name
Damascus University
City
Damascus
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15000003
Citation
Weerheijm KL. Molar incisor hypomineralization (MIH): clinical presentation, aetiology and management. Dent Update. 2004 Jan-Feb;31(1):9-12. doi: 10.12968/denu.2004.31.1.9.
Results Reference
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PubMed Identifier
27121068
Citation
Silva MJ, Scurrah KJ, Craig JM, Manton DJ, Kilpatrick N. Etiology of molar incisor hypomineralization - A systematic review. Community Dent Oral Epidemiol. 2016 Aug;44(4):342-53. doi: 10.1111/cdoe.12229. Epub 2016 Apr 28.
Results Reference
background
PubMed Identifier
25674916
Citation
Melin L, Lundgren J, Malmberg P, Noren JG, Taube F, Cornell DH. XRMA and ToF-SIMS Analysis of Normal and Hypomineralized Enamel. Microsc Microanal. 2015 Apr;21(2):407-21. doi: 10.1017/S1431927615000033. Epub 2015 Feb 12.
Results Reference
background
PubMed Identifier
20403301
Citation
Lygidakis NA, Wong F, Jalevik B, Vierrou AM, Alaluusua S, Espelid I. Best Clinical Practice Guidance for clinicians dealing with children presenting with Molar-Incisor-Hypomineralisation (MIH): An EAPD Policy Document. Eur Arch Paediatr Dent. 2010 Apr;11(2):75-81. doi: 10.1007/BF03262716.
Results Reference
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PubMed Identifier
30888581
Citation
Dhareula A, Goyal A, Gauba K, Bhatia SK, Kapur A, Bhandari S. A clinical and radiographic investigation comparing the efficacy of cast metal and indirect resin onlays in rehabilitation of permanent first molars affected with severe molar incisor hypomineralisation (MIH): a 36-month randomised controlled clinical trial. Eur Arch Paediatr Dent. 2019 Oct;20(5):489-500. doi: 10.1007/s40368-019-00430-y. Epub 2019 Mar 19.
Results Reference
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PubMed Identifier
31593607
Citation
Gaton-Hernandez P, Serrano CR, da Silva LAB, de Castaneda ER, da Silva RAB, Pucinelli CM, Manton D, Ustrell-Torrent JM, Nelson-Filho P. Minimally interventive restorative care of teeth with molar incisor hypomineralization and open apex-A 24-month longitudinal study. Int J Paediatr Dent. 2020 Jan;30(1):4-10. doi: 10.1111/ipd.12581. Epub 2019 Oct 24.
Results Reference
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Evaluation Direct and Indirect Composite Restoration in Hypomineralization Molars.
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