Evaluation Direct and Indirect Composite Restoration in Hypomineralization Molars.

Not Applicable

Completed

• Conditions: Dental Caries; Dental Enamel Hypoplasia
• Interventions: Other: Indirect restoration; Other: Direct restoration

• Registration Number: NCT05299489
• Lead Sponsor: Damascus University

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.

Study Timeline

• Study Start: 2020-10-15
• Primary Completion: 2021-12-25
• Study Completion: 2022-02-15
• Status Verified: 2022-03
• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-18
• Last Update Submitted: 2022-03-18
• Study First Posted: 2022-03-29
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Indirect composite in hypomineraliztion molars.	Indirect restoration	-
Direct composite in hypomineraliztion molars.	Direct restoration	-

Primary Outcome Measures

Name	Time	Method
Clinical evaluation of teeth restored by direct composite.	12 months after applying the restoration	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.	12 months after applying the restoration	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).

Trial Locations

Locations (1)

Damascus University; 🇸🇾 Damascus, Syrian Arab Republic