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Evaluation Direct and Indirect Composite Restoration in Hypomineralization Molars.

NCT05299489 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-03-29

No results posted yet for this study

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

Interventions

OTHER

Direct restoration

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.

OTHER

Indirect restoration

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.

Sponsors & Collaborators

  • Damascus University

    lead OTHER

Principal Investigators

  • Abdulrhman S Hakmi · MSc student in Pedodontics, University of Damascus

  • Mayssoon Dashash, Phd · Professor of Pedodontics, Department of Pedodontics, University of Damascus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2021-12-25
Completion
2022-02-15

Countries

  • Syria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05299489 on ClinicalTrials.gov