NCT07718191

Brief Summary

The aim of this clinical trial is to evaluate the clinical success of 3D printed Indirect hybrid resin restorations in the hypomineralized first permanent molars.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

July 8, 2026

Last Update Submit

July 17, 2026

Conditions

Molar-Incisor Hypomineralization (MIH)

Keywords

MIH

Outcome Measures

Primary Outcomes (1)

  • evaluation of self-reported pain

    Self-reported pain was assessed considering each MIH affected FPM included in the study, using the faces pain scale-revised (FPS-R) before and after the restoration. This scale is made up of six faces, each representing an increase in the degree of pain fromleft to right. The scores of the faces are 0, 2, 4, 6, 8, and 10

    12 months

Secondary Outcomes (1)

  • percentage of clinical survival of restoration

    12 months

Study Arms (2)

3d printed restoration

EXPERIMENTAL
Other: 3d printed restoration

direct composite restoration

ACTIVE COMPARATOR
Other: composite

Interventions

compositeOTHER

direct resin composite

direct composite restoration
3d printed restorationOTHER

3d hybrid resin restoration

3d printed restoration

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Participants aged from 7 years to 11 years
  • MIH-TNI 2 or 4
  • No past dental treatment for the hypomineralized first permanent mandibular molars.
  • Caries lesions that include the occlusal surface.

You may not qualify if:

  • The presence of systemic disease, physical or mental disability.
  • Any potential confounding enamel defects i.e., amelogenesis imperfecta.
  • Uncooperative children.
  • A history of allergic reactions to local anesthetics or some components of restorative materials
  • History of spontaneous pain.
  • Presence of clinical or radiographic signs of pulp necrosis (Fistula/abscess, internal or external root resorption, mobility of the tooth, and swelling).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

elhabbak

CONTACT

+201005889936mahahabbak6@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

July 8, 2026

First Posted

July 21, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 21, 2026

Record last verified: 2026-07