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Molar Incisor HypomineralizationNCT04654858

Hypersensitivity After Composite Restoration Versus Preformed Metal Crowns in MIH Molars

A study testing Direct composite restorations and Preformed metal crowns (PMCs) in people with Molar Incisor Hypomineralization, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to assess the hypersensitivity after direct composite restorations (DCRs) versus preformed metal crowns (PMCs) in molars affected with molar-incisor hypomineralization (MIH). Read more about this study

Who is it for?
Ages 7 to 12 years
Conditions the study is for
Molar Incisor Hypomineralization
What is being tested?
Direct composite restorations and Preformed metal crowns (PMCs)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
4 Jul 2021to 5 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children with MIH in one fully erupted molar or more.
  • Age ranging from 7-12 years.
  • cooperative children
  • Good general health.

Who cannot join

  • patients participating in other experiments.
  • Patients with parents planning to move away within the following year.
  • Patients with only mildly affected MIH molars that do not require extensive restorative treatment.
  • MIH-affected molars that have a very poor prognosis and require extraction.
  • First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta.
  • -

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Oral and Dental Medicine

    Cairo

Other trials in Egypt

About this study

Official title: Hypersensitivity After Direct Composite Restorations Versus Preformed Metal Crowns in Molars Affected With Molar-incisor Hypomineralization Among a Group of Egyptian Children: a Randomized Controlled Trial (Part II).

The aim of this study is to assess the hypersensitivity after direct composite restorations (DCRs) versus preformed metal crowns (PMCs) in molars affected with molar-incisor hypomineralization (MIH).

Read the detailed description

Molar incisor hypomineralization can represent a serious and challenging clinical management problem. Children with MIH require higher levels of treatment needs and demonstrate considerable management problems.

For most severely affected MIH molars, direct esthetic restorative materials or preformed metal crowns will be the treatments to choose between. A number of aspects which could support decision-making, however, are not clearly demarcated. First and foremost, it is not clear if both treatments are similarly acceptable for patients and providers.

Being tested
Direct composite restorations, Preformed metal crowns (PMCs)
Keywords
MIH
Medical subject headings
Molar Hypomineralization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Direct composite restorationsProcedure or surgery

    Also called composite resin

    bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used aftar infiltration or block anaesthesia for affected molar,following by carious tissue removal. Marginal bevelling of enamel will be performed. A universal adhesive (Scotchbond Universal, 3M Espe) will be placed after selective enamel etching A bulk-fill composite will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe).

  • Preformed metal crowns (PMCs)Procedure or surgery

    Also called stainless steel crowns

    The PMCs (3M Espe, Seefeld, Germany) will be placed after infiltration or block anesthesia for a maxillary or mandibular affected molar, followed by carious tissue removal using the pediatric bur. Tooth preparation for fitting the crown includes minimal reduction of occlusal and proximal surfaces if necessary. The correct size of crown will be chosen by trial-and-error technique or by measuring the mesiodistal dimension, and then cemented with glass ionomer luting cement (Ketac Cem, 3M Espe).

Study groups in NCT04654858
Study groupRoleWhat they receive
Direct composite restorationsActive comparatorbulk-fill composite (Filtek BulkFlow, 3M Espe) will be used after infiltration or block anaesthesia for affected molar, following by carious tissue removal. Marginal bevelling of enamel will be performed. A universal adhesive (Scotchbond Universal, 3M Espe) will be placed after selective enamel etching A bulk-fill composite will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe).
Receives: Procedure: Direct composite restorations
Preformed metal crowns (PMCs)Active comparatorPMCs (3M Espe, Seefeld, Germany) will be placed after infiltration or block anaesthesia for affected molar, followed by removal of carious dentin and enamel, Tooth preparation for fitting the crown, The correct size of crown will be chosen, and then Cemented with glass ionomer luting cement (KetacCem, 3M Espe).
Receives: Procedure: Preformed metal crowns (PMCs)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hypersensitivity

    Questioning the patient and/or the parent Binary (yes, no)

    Measured: 12 month

Secondary outcomes (5)

  1. restoration quality

    (FDI criteria; criterion marginal adaptation) Five scores three for acceptable and two for non-acceptable (one for reparable and one for replaceable).

    Measured: 12 month

  2. health-related quality of life changes by the therapies.

    (measured as difference in Child Perceptions Questionnaire CPQ 8-10/11-14) Score index.

    Measured: 12 month

  3. Acceptability of the treatment

    Questioning the children or parents about accepting the treatment. Binary (Yes or no).

    Measured: 12 month

  4. Parental satisfaction

    Questioning the parent. Binary (Yes or no).

    Measured: 12 month

  5. initial and follow-up treatment costs

    Average cost effectiveness ratio(ACER) incremental cost effectiveness ratio(ICER), and the measuring unit is EGP

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2020
  2. Study start4 Jul 2021
  3. Primary completion3 Sep 2023
  4. Study completion5 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04654858
Sponsor's protocol ID
treatment of teeth with MIH
Status last verified
Oct 2026
First submitted
3 Nov 2020
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • • • Alanzi A, Faridoun A, Kavvadia K, Ghanim A. 2018. Dentists' perception, knowledge, and clinical management of molar-incisor-hypomineralisation in kuwait: A cross-sectional study. BMC oral health. 18(1):34. • Bakkal M, Abbasoglu Z, Kargul B. 2017. The effect of casein phosphopeptide-amorphous calcium phosphate on molar-incisor hypomineralisation: A pilot study. Oral health & preventive dentistry. 15(2):163-167. • Baroni C, Marchionni S. 2011. Mih supplementation strategies: Prospective clinical and laboratory trial. Journal of dental research. 90(3):371-376. • Bekes K, Heinzelmann K, Lettner S, Schaller HG. 2016. Efficacy of desensitizing products containing 8% arginine and calcium carbonate for hypersensitivity relief in mih-affected molars: An 8-week clinical study. Clinical oral investigations. • Bekes K, Steffen R. 2016. Das würzburger mih - konzept: Teil 1. Der mih - treatment need index (mih - tni). Ein neuer index zur befunderhebung und therapieplanung bei patienten mit molaren - inzisiven hypomineralisation Oralprophylaxe & Kinderzahnheilkunde. 38(4):165-170. • Briggs A, Sculpher M. 1997. Commentary: Markov models of medical prognosis. BMJ. 314 (7077):345-345.Briggs AH, O'Brien BJ, Blackhouse G. 2002. Thinking outside the box: Recent advances in the analysis and presentation of uncertainty in cost-effectiveness studies. Annual Review of Public Health. 23(1):377-401. • Byford, S., Knapp, M., Greenshields, J., Byford, S., Knapp, M., Greenshields, J., et al (2003) Cost-effectiveness of brief cognitive behaviour therapy Cost-effectiveness of brief cognitive behaviour therapy versus treatment as usual in recurrent deliberate self- versus treatment as usual in recurrent deliberate selfharm: a rational decision making approach. harm: a rational decision making approach. Psychological Psychological MedicineMedicine, 33, 977 • Cuzick J. 2005. Rank regression. Encyclopedia of biostatistics vol 6. Wiley and Sons. de Souza JF, Fragelli CB, Jeremias F, Paschoal MAB, Santos-Pinto L, de Cassia Loiola Cordeiro R. 2017. • Eighteen-month clinical performance of composite resin restorations with two different adhesive systems for molars affected by molar incisor hypomineralization. Clinical oral investigations. 21(5):1725-1733. • Dworkin SL. 2012. Sample size policy for qualitative studies using in-depth interviews. Archives of sexual behavior. 41(6):1319-1320. • Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA. 2016. Consort 2010 statement: Extension to randomised pilot and feasibility trials. Bmj. 355:i5239

Questions about this trial

What is this clinical trial studying?

A study testing Direct composite restorations and Preformed metal crowns (PMCs) in people with Molar Incisor Hypomineralization, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypersensitivity (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04654858, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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