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AzTrials

Molar Incisor HypomineralizationNCT04658602

Restoration of Permanent Molars Affected With (MIH) Using Composite Restorations or Preformed Metal Crowns

A study testing Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe) in people with Molar Incisor Hypomineralization, run by Nada Mahmoud Abd El-Azim Mohamed at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to compare clinical outcome of using direct esthetic composite restorations in managing MIH cases and the use of preformed metal crowns. 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?
Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
Dec 2020to Dec 2021
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.

Nada Mahmoud Abd el-azim Mohamed, Bachelor contact

+201126696236

nada.abdelazim@dentistry.cu.edu.eg

Prof.Dr.eman Elmasry, Prof.Dr. contact

Egypt1 site, 1 recruiting

  • Faculty of oral and dental medicine,Cairo University

    Cairo

    Recruiting

Other trials in Egypt

About this study

Official title: Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns : Two-arm Randomized Controlled Trial (Part III)

The aim of this study is to compare clinical outcome of using direct esthetic composite restorations in managing MIH cases and the use of preformed metal crowns.

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
Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)
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.

  • Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)Procedure or surgery

    Covering the affected molar with preformed metal crown cemented by glass ionomer lutting cement

Study groups in NCT04658602
Study groupRoleWhat they receive
Direct composite restorationActive comparatorBulk-fill composite (Filtek bulk flow, 3M Espe ) will be used and covered using a nanohybrid copmosite (filtek XT, 3M Espe )
Receives: Procedure: Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)
Preformed metal crownsActive comparatorPreformed stainless-steal crowns cemented by glass ionomer lutting cement (ketac cem. 3M Espe )
Receives: Procedure: Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)

What is being measured

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

  1. Pain after the restoration Binary (yes or no )

    Questionnaire

    Measured: 12 month

Secondary outcomes (3)

  1. Acceptability of the treatment Binary (yes or no )

    Questionnaire

    Measured: 12 month

  2. Restoration quality score index

    (FDI criteria: criterion marginal adaptation

    Measured: 12 month

  3. Health-related quality of life changes by the therapies

    Measured as difference in child perceptions Questionnaire CPQ 8-10/11-14)

    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 posted8 Dec 2020
  2. Study startDec 2020 (estimated)
  3. Primary completion1 Oct 2021 (estimated)
  4. Study completionDec 2021 (estimated)

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
Model description
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04658602
Sponsor's protocol ID
ttt of teeth with MIH part III
Status last verified
Dec 2020
First submitted
9 Nov 2020
Last updated
8 Dec 2020
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 Elhennawy K, Jost-Brinkmann PG, Manton DJ, Paris S, Schwendicke F. 2017a. Managing molars with severe molar-incisor hypomineralization: A cost-effectiveness analysis within german healthcare. Journal of dentistry. 63:65-71. Elhennawy K, Manton DJ, Crombie F, Zaslansky P, Radlanski RJ, Jost-Brinkmann PG, Schwendicke F. 2017b. Structural, mechanical and chemical evaluation of molar-incisor hypomineralization-affected enamel: A systematic review. Archives of oral biology. 83:272-281. Elhennawy K, Schwendicke F. 2016. Managing molar-incisor hypomineralization: A systematic review. Journal of dentistry. 55:16-24. Foster Page LA, Thomson WM, Jokovic A, Locker D. 2005. Validation of the child perceptions questionnaire (cpq 11-14). Journal of dental research. 84(7):649-652. Fragelli CM, Souza JF, Jeremias F, Cordeiro Rde C, Santos-Pinto L. 2015. Molar incisor hypomineralization (mih): Conservative treatment management to restore affected teeth. Brazilian oral research. 29. Fragelli CMB, Souza JF, Bussaneli DG, Jeremias F, Santos-Pinto LD, Cordeiro RCL. 2017. Survival of sealants in molars affected by molar-incisor hypomineralization: 18-month follow-up. Brazilian oral research. 31:e30. Gaardmand E, Poulsen S, Haubek D. 2013. Pilot study of minimally invasive cast adhesive copings for early restoration of hypomineralised first permanent molars with post-eruptive breakdown. European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry. 14(1):35-39. Gambetta-Tessini K, Marino R, Ghanim A, Calache H, Manton DJ. 2016. Knowledge, experience and perceptions regarding molar-incisor hypomineralisation (mih) amongst australian and chilean public oral health care practitioners. BMC oral health. 16(1):75.

Questions about this trial

What is this clinical trial studying?

A study testing Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe) in people with Molar Incisor Hypomineralization, run by Nada Mahmoud Abd El-Azim Mohamed 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 5 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: status not confirmed, as of the sponsor's last update on 8 Dec 2020. 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?

Results are not available in the source record.

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

Contact Nada Mahmoud Abd el-azim Mohamed, Bachelor (+201126696236, nada.abdelazim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain after the restoration Binary (yes or no ) (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 NCT04658602, 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 8 Dec 2020.

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