Direct Composite Versus Indirect Hybrid Resin Restorations in Hypomineralized First Permanent Molars

Clinical Evaluation of Direct Composite Versus Indirect Hybrid Resin Restorations in Hypomineralized First Permanent Molars: A Randomized Clinical Trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07718191

Enrollment

Registered

2026-07-21

Start date

2026-10-01

Completion date

2027-12-01

Last updated

2026-07-21

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

Conditions

Molar-Incisor Hypomineralization (MIH)

Keywords

MIH

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.

Interventions

OTHER3d printed restoration

3d hybrid resin restoration

OTHERcomposite

direct resin composite

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

7 Years to 11 Years

Healthy volunteers

Inclusion criteria

1. Participants aged from 7 years to 11 years 2. MIH-TNI 2 or 4 3. No past dental treatment for the hypomineralized first permanent mandibular molars. 4. Caries lesions that include the occlusal surface.

Exclusion criteria

1. The presence of systemic disease, physical or mental disability. 2. Any potential confounding enamel defects i.e., amelogenesis imperfecta. 3. Uncooperative children. 4. A history of allergic reactions to local anesthetics or some components of restorative materials 5. History of spontaneous pain. 6. Presence of clinical or radiographic signs of pulp necrosis (Fistula/abscess, internal or external root resorption, mobility of the tooth, and swelling).

Design outcomes

Primary

Measure	Time frame	Description
evaluation of self-reported pain	12 months	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

Secondary

Measure	Time frame	Description
percentage of clinical survival of restoration	12 months	Restorations were clinically evaluated according to the restoration quality analysis criteria proposed by the United States Public Health Services USPHS-Modified for periods of 6 and 12 months

Contacts

CONTACTelhabbak

mahahabbak6@gmail.com+201005889936

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026