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Evaluation Direct and Indirect Composite Restoration in Hypomineralization Molars.

Clinical Randomized Controlled Trial To Compare Direct and Indirect Composite Restoration in Children With Molar Incisor Hypomineralization Patients (MIH)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05299489
Enrollment
20
Registered
2022-03-29
Start date
2020-10-15
Completion date
2022-02-15
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Dental Enamel Hypoplasia

Keywords

MIH, Direct composite, Indirect composite, Permanent molars

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.

Interventions

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.

OTHERIndirect 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

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Intervention model description

Split mouth design

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

1. Age between 8 and 12 years. 2. Definitely positive or positive ratings of Frank scale. 3. The first permanent molars must achieve the following criteria: The molar must be suffering from severe demineralization and it must be restorable with composite. 4. caries lesions include the occlusal surface and should not extend more than thirds of the thickness of dentin 5. Absence clinical and radiographic signs which indicate pulp necrosis

Exclusion criteria

1. Systematic or mental disorders. 2. Definitely negative or negative ratings of Frankel scale 3. Existence periapical translucence 4. Existence external or internal abnormal absorption 5. Existence swelling or fistula 6. Sensitivity to percussion 7. Existence of spontaneous or stimulant pain

Design outcomes

Primary

MeasureTime frameDescription
Clinical evaluation of teeth restored by direct composite.3 months after applying the restorationClinical 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.3 months after applying the restorationClinical 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).

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026