Evaluation Direct and Indirect Composite Restoration in Hypomineralization Molars.

NCT05299489 | Completed

• 1 other identifier: UDDS-Pedo-10-2022
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Enamel Hypoplasia; Dental Caries

Keywords

MIH; Direct composite; Indirect composite; Permanent molars

Outcome Measures

Primary Outcomes (6)

• 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).

  3 months after applying the restoration

• 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).

  6 months after applying the restoration

• 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).

  12 months after applying the restoration

• 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).

  3 months after applying the restoration

• 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).

  6 months after applying the restoration

• 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).

  12 months after applying the restoration

Study Arms (2)

Direct composite in hypomineraliztion molars.

EXPERIMENTAL

Other: Direct restoration

Indirect composite in hypomineraliztion molars.

OTHER

Other: Indirect restoration

Interventions

Direct restoration OTHER

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.

Direct composite in hypomineraliztion molars.

Indirect restoration OTHER

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.

Indirect composite in hypomineraliztion molars.

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, Syria

Location

Related Publications (6)

• 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.

  PMID: 15000003 BACKGROUND

• 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.

  PMID: 27121068 BACKGROUND

• 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.

  PMID: 25674916 BACKGROUND

• 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.

  PMID: 20403301 BACKGROUND

• 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.

  PMID: 30888581 BACKGROUND

• 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.

  PMID: 31593607 BACKGROUND

MeSH Terms

Conditions

Dental Enamel Hypoplasia; Dental Caries

Condition Hierarchy (Ancestors)

Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tooth Demineralization

Study Officials

• Abdulrhman S Hakmi

  MSc student in Pedodontics, University of Damascus

  PRINCIPAL INVESTIGATOR

• Mayssoon Dashash, Phd

  Professor of Pedodontics, Department of Pedodontics, University of Damascus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split mouth design

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 29, 2022
• Study Start: October 15, 2020
• Primary Completion: December 25, 2021
• Study Completion: February 15, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)