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Not yet recruitingNCT07718191Updated Jul 21, 2026

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

An interventional study of 3d printed restoration and composite in Molar-Incisor Hypomineralization (MIH), sponsored by Cairo University. Not yet recruiting. Open to participants aged 7 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
7 Years to 11 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Molar Hypomineralization by Cairo University — 9 open to participants now, 9 under way, 1 of them phase 3. Molar Hypomineralization · Cairo University.

Planned enrollment
6th of 10
40 · median 44
Started
2026
the only one that year
No phase
8 of 22
4 open now
Registered
22nd of 22
by date

Among the 22 studies in Molar Hypomineralization by Cairo University, this one is the 6th largest by planned enrollment of the 10 interventional ones, is the only one that started in 2026, is one of 8 with no phase, and was the 22nd registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

Observational12 · 4 open
No phasethis study8 · 4 open
Phase 11 · 0 open
Phase 31 · 1 open

By the year they started

First in 2018; this study’s year is marked. 1 started in 2026.

Size and results

Median enrollment 44 across the 10 interventional studies, 190 across the 12 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.

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02

Study 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.

03

Conditions studied

  • Molar-Incisor Hypomineralization (MIH)

Keywords

  • MIH
04

Who can participate

Ages eligible
7 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    3d printed restoration

    Other: 3d printed restoration

  • Active comparator
    direct composite restoration

    Other: composite

Interventions

  • Other3d printed restoration

    3d hybrid resin restoration

  • Othercomposite

    direct resin composite

06

What researchers measure

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

    Time frame: 12 months

Secondary outcomes

  1. percentage of clinical survival of restoration

    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

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.

Of 62 non-industry interventional studies with no phase under Molar Hypomineralization, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 25. This study's planned 14 months is close to that.

Counting every sponsor, half of 62 studies reached it within 14 months; a quarter within 8 and three quarters within 25.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2026
First posted
Jul 21, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Jul 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07718191
Lead sponsor
Cairo University
Responsible party
Maha Elhabbak (Assistant Lecturer, Cairo University) — Principal investigator
First posted
Jul 21, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 21, 2026

Study contacts

elhabbak
Contact
mahahabbak6@gmail.com
+201005889936

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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