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Minimally Invasive Treatment for Permanent Molars Affected With Molar-incisor Hypomineralization Defects

Primary Purpose

Molar Incisor Hypomineralization

Status
Recruiting
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
SDF
HVGIC restoration
SSC
Sponsored by
King Abdullah University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Permanent molars with MIH with the following MIH indices (2a, 2b, 3, 4a, 4b) affected by caries (ICDAS 3 or 4) or post eruptive breakdown. Restorable teeth Permanent molars with MIH with NO clinical/radiographic signs and symptoms of irreversible pulpitis or pulpal necrosis. Clear band of dentine radiographically between the carious lesion and the pulp. Exclusion Criteria: Medically compromised patients. Permanent molars with MIH with the following indices (1, 2c, 4c, 0, 1). Permanent molars with MIH with severe post eruptive breakdown therefore, unrestorable. Permanent molars with MIH with clinical/radiographic signs and symptoms of irreversible pulpitis or pulpal necrosis. No clear band of dentine radiographically between the carious lesion and the pulp.

Sites / Locations

  • Jordan University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1: SDF, HVGIC & SSC

Group 2: SDF & SSC

Group 3: HVGIC & SSC

Arm Description

Silver diamine fluoride (SDF) will be clinically applied in the first visit. After 1 week of caries arrest, the tooth will be restored with a high viscosity glass ionomer (HVGIC) and stainless steel crown (SSC).

Silver diamine fluoride (SDF) will be clinically applied in the first visit. After 1 week of caries arrest, the tooth will be restored with a SSC only.

The tooth will be restored in a similar fashion to atraumatic restorative treatment (ART technique) and restored with a high viscosity glass ionomer (HVGIC) and stainless steel crown (SSC).

Outcomes

Primary Outcome Measures

Successful restoration
SSC is clinically intact (not perforated), retentive (not lost), in proper occlusion, with no gingival inflammation
Functional tooth clinically
Tooth should have no symptoms of pain, mobility or tenderness to percussion
Healthy periapical region radiographically
No signs of periapical pathology on radiograph

Secondary Outcome Measures

Full Information

First Posted
February 5, 2023
Last Updated
March 5, 2023
Sponsor
King Abdullah University Hospital
Collaborators
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05748067
Brief Title
Minimally Invasive Treatment for Permanent Molars Affected With Molar-incisor Hypomineralization Defects
Official Title
Outcome of Minimally Invasive Treatment for Permanent Molars Affected With Molar-incisor Hypomineralization Defects: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Abdullah University Hospital
Collaborators
Jordan University of Science and Technology

4. Oversight

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

5. Study Description

Brief Summary
In this prospective randomized clinical trial, the is aim to compare the clinical and radiographic success of 3 minimally invasive treatment protocols on permanent first molars affected with MIH over 24 months. A total of 135 children/molar teeth (N=45 per group) between the ages of 6-16 years with MIH will be recruited at the post-graduate clinics at Jordan University of Science and Technology (JUST).
Detailed Description
Background: The term molar-incisor hypomineralization (MIH) is defined as 'hypomineralization of systemic origin, presenting as demarcated, qualitative defects of enamel of one to four first permanent molars (FPMs) frequently associated with affected incisors. There are no clinical studies on use of minimally invasive techniques as restorative treatments for molars affected by MIH. Aim: The aim of this clinical trial is to compare the clinical and radiographic success of 3 minimally invasive treatment protocols on permanent first molars affected with MIH over 24 months. Methods: A total of 135 children/molar teeth (N=45 per group) between the ages of 6-16 years with MIH will be recruited for this prospective randomized clinical trial in the post-graduate clinics at JUST. Clinical and radiographic examination will be done. Participants will be randomly allocated to one of the three treatment modalities: For groups 1 and 2, silver diamine fluoride (SDF) will be clinically applied using cotton roll isolation on the first visit for three minutes after cleaning the tooth with gauze. After 1 week, the carious lesion will be examined for signs of caries arrest using two criteria: the color turning darker black and increased hardness of the lesion rather than soft texture (assessed using an excavator), if the criteria are met, the tooth will be restored with high viscosity glass ionomer (HVGIC) and stainless steel crown (SSC) for group 1, or only with a SCC for group 2. If not met, the carious lesion will be assumed to be still active, and a reapplication of SDF will be done before restoring the tooth with HVGIC and SCC. In group 3, the tooth will be restored in a similar fashion to atraumatic restorative treatment (ART technique) and restored with HVGIC and a SCC. Follow up will be done for all groups at 3 months, 6 months, 12 months, and 24 months to record specified clinical and radiographic criteria as outcome measures of success. Expected results: It is expected that there will be no difference between different minimally invasive restorative treatments for MIH; namely, restoring teeth using a SSC after SMART (SDF and HVGIC), SDF treatment alone, or ART (HVGIC alone).

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
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: SDF, HVGIC & SSC
Arm Type
Active Comparator
Arm Description
Silver diamine fluoride (SDF) will be clinically applied in the first visit. After 1 week of caries arrest, the tooth will be restored with a high viscosity glass ionomer (HVGIC) and stainless steel crown (SSC).
Arm Title
Group 2: SDF & SSC
Arm Type
Active Comparator
Arm Description
Silver diamine fluoride (SDF) will be clinically applied in the first visit. After 1 week of caries arrest, the tooth will be restored with a SSC only.
Arm Title
Group 3: HVGIC & SSC
Arm Type
Active Comparator
Arm Description
The tooth will be restored in a similar fashion to atraumatic restorative treatment (ART technique) and restored with a high viscosity glass ionomer (HVGIC) and stainless steel crown (SSC).
Intervention Type
Procedure
Intervention Name(s)
SDF
Intervention Description
Silver diamine fluoride
Intervention Type
Procedure
Intervention Name(s)
HVGIC restoration
Intervention Description
High viscosity glass ionomer restoration
Intervention Type
Procedure
Intervention Name(s)
SSC
Intervention Description
Stainless steel crown
Primary Outcome Measure Information:
Title
Successful restoration
Description
SSC is clinically intact (not perforated), retentive (not lost), in proper occlusion, with no gingival inflammation
Time Frame
After 1 year
Title
Functional tooth clinically
Description
Tooth should have no symptoms of pain, mobility or tenderness to percussion
Time Frame
After 1 year
Title
Healthy periapical region radiographically
Description
No signs of periapical pathology on radiograph
Time Frame
After 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Permanent molars with MIH with the following MIH indices (2a, 2b, 3, 4a, 4b) affected by caries (ICDAS 3 or 4) or post eruptive breakdown. Restorable teeth Permanent molars with MIH with NO clinical/radiographic signs and symptoms of irreversible pulpitis or pulpal necrosis. Clear band of dentine radiographically between the carious lesion and the pulp. Exclusion Criteria: Medically compromised patients. Permanent molars with MIH with the following indices (1, 2c, 4c, 0, 1). Permanent molars with MIH with severe post eruptive breakdown therefore, unrestorable. Permanent molars with MIH with clinical/radiographic signs and symptoms of irreversible pulpitis or pulpal necrosis. No clear band of dentine radiographically between the carious lesion and the pulp.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ola B. Al-Batayneh
Phone
027201000
Email
olabt@just.edu.jo
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ola B. Al-Batayneh
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan University of Science and Technology
City
Irbid
ZIP/Postal Code
22110
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ola B. Al-Batayneh
Phone
027201000
Email
olabt@just.edu.jo

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28721667
Citation
Ghanim A, Silva MJ, Elfrink MEC, Lygidakis NA, Marino RJ, Weerheijm KL, Manton DJ. Molar incisor hypomineralisation (MIH) training manual for clinical field surveys and practice. Eur Arch Paediatr Dent. 2017 Aug;18(4):225-242. doi: 10.1007/s40368-017-0293-9. Epub 2017 Jul 18.
Results Reference
background
PubMed Identifier
24683770
Citation
Ozgul BM, Saat S, Sonmez H, Oz FT. Clinical evaluation of desensitizing treatment for incisor teeth affected by molar-incisor hypomineralization. J Clin Pediatr Dent. 2013 Winter;38(2):101-5.
Results Reference
background
PubMed Identifier
28913739
Citation
Steffen R, Kramer N, Bekes K. The Wurzburg MIH concept: the MIH treatment need index (MIH TNI) : A new index to assess and plan treatment in patients with molar incisior hypomineralisation (MIH). Eur Arch Paediatr Dent. 2017 Oct;18(5):355-361. doi: 10.1007/s40368-017-0301-0. Epub 2017 Sep 14.
Results Reference
background
PubMed Identifier
11853245
Citation
Jalevik B, Klingberg GA. Dental treatment, dental fear and behaviour management problems in children with severe enamel hypomineralization of their permanent first molars. Int J Paediatr Dent. 2002 Jan;12(1):24-32.
Results Reference
background
PubMed Identifier
28542863
Citation
Zhao IS, Gao SS, Hiraishi N, Burrow MF, Duangthip D, Mei ML, Lo EC, Chu CH. Mechanisms of silver diamine fluoride on arresting caries: a literature review. Int Dent J. 2018 Apr;68(2):67-76. doi: 10.1111/idj.12320. Epub 2017 May 21.
Results Reference
background
PubMed Identifier
29669561
Citation
Grossi JA, Cabral RN, Ribeiro APD, Leal SC. Glass hybrid restorations as an alternative for restoring hypomineralized molars in the ART model. BMC Oral Health. 2018 Apr 18;18(1):65. doi: 10.1186/s12903-018-0528-0.
Results Reference
background
PubMed Identifier
26897901
Citation
Horst JA, Ellenikiotis H, Milgrom PL. UCSF Protocol for Caries Arrest Using Silver Diamine Fluoride: Rationale, Indications and Consent. J Calif Dent Assoc. 2016 Jan;44(1):16-28.
Results Reference
background
PubMed Identifier
29070149
Citation
Crystal YO, Marghalani AA, Ureles SD, Wright JT, Sulyanto R, Divaris K, Fontana M, Graham L. Use of Silver Diamine Fluoride for Dental Caries Management in Children and Adolescents, Including Those with Special Health Care Needs. Pediatr Dent. 2017 Sep 15;39(5):135-145.
Results Reference
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Minimally Invasive Treatment for Permanent Molars Affected With Molar-incisor Hypomineralization Defects

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