Clinical trial NCT05299489: Evaluation Direct and Indirect Composite Restoration in Hypomineralization Molars.
Official title: Clinical Randomized Controlled Trial To Compare Direct and Indirect Composite Restoration in Children With Molar Incisor Hypomineralization Patients (MIH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Enamel Hypoplasia
Dental Caries
Keywords: MIH
Direct composite
Indirect composite
Permanent molars
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Split mouth design
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness of direct and Indirect Composite Restoration in Children With Molar Incisor Hypomineralization Patients (MIH) and following up after 3 , 6 , 12 months (Clinically):

Group A ( Control group ): Hypomineralization molars were restored by direct composite.

Group B ( Experimental group ): Hypomineralization molars were restored by indirect composite.

Detailed description: Pediatric dentists face a high prevalence of MIH ranging from 3 to 40%, so it is relatively common condition that would cause treatment challenges due to severe sensitivity, breakdown of the occlusal surface, difficulty anesthesia and relatively high failure of restorations as a result of marginal breakdown of restorations.

There are many treatment options available to restore these teeth. In mild and moderate cases, they are restored using direct composite resin. In cases where teeth are severely affected, the treatment is more complicated, including stainless steel crowns and different types of full or partial indirect crowns.

Direct composite resin restorations are the treatment option in the majority of clinical cases, but in severe cases, the results of treatment are often unsatisfactory.

Indirect composite restorations are an aesthetic alternative to cast metal inlays and stainless steel crowns with minimal microleakage.

Eligibility criteria: Inclusion Criteria:

1. Age between 8 and 12 years.
2. Definitely positive or positive ratings of Frank scale.
3. The first permanent molars must achieve the following criteria: The molar must be suffering from severe demineralization and it must be restorable with composite.
4. caries lesions include the occlusal surface and should not extend more than thirds of the thickness of dentin
5. Absence clinical and radiographic signs which indicate pulp necrosis

Exclusion Criteria:

1. Systematic or mental disorders.
2. Definitely negative or negative ratings of Frankel scale
3. Existence periapical translucence
4. Existence external or internal abnormal absorption
5. Existence swelling or fistula
6. Sensitivity to percussion
7. Existence of spontaneous or stimulant pain

Primary outcomes:
measure: Clinical evaluation of teeth restored by direct composite.
timeFrame: 3 months after applying the restoration
measure: Clinical evaluation of teeth restored by direct composite.
timeFrame: 6 months after applying the restoration
measure: Clinical evaluation of teeth restored by direct composite.
timeFrame: 12 months after applying the restoration
measure: Clinical evaluation of teeth restored by indirect composite.
timeFrame: 3 months after applying the restoration
measure: Clinical evaluation of teeth restored by indirect composite.
timeFrame: 6 months after applying the restoration
measure: Clinical evaluation of teeth restored by indirect composite.
timeFrame: 12 months after applying the restoration
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
affiliation: MSc student in Pedodontics, University of Damascus
name: Abdulrhman S Hakmi
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Pedodontics, Department of Pedodontics, University of Damascus
name: Mayssoon Dashash, Phd
role: STUDY_DIRECTOR
References:
citation: Weerheijm KL. Molar incisor hypomineralization (MIH): clinical presentation, aetiology and management. Dent Update. 2004 Jan-Feb;31(1):9-12. doi: 10.12968/denu.2004.31.1.9.
citation: Silva MJ, Scurrah KJ, Craig JM, Manton DJ, Kilpatrick N. Etiology of molar incisor hypomineralization - A systematic review. Community Dent Oral Epidemiol. 2016 Aug;44(4):342-53. doi: 10.1111/cdoe.12229. Epub 2016 Apr 28.
citation: Melin L, Lundgren J, Malmberg P, Noren JG, Taube F, Cornell DH. XRMA and ToF-SIMS Analysis of Normal and Hypomineralized Enamel. Microsc Microanal. 2015 Apr;21(2):407-21. doi: 10.1017/S1431927615000033. Epub 2015 Feb 12.
citation: Lygidakis NA, Wong F, Jalevik B, Vierrou AM, Alaluusua S, Espelid I. Best Clinical Practice Guidance for clinicians dealing with children presenting with Molar-Incisor-Hypomineralisation (MIH): An EAPD Policy Document. Eur Arch Paediatr Dent. 2010 Apr;11(2):75-81. doi: 10.1007/BF03262716.
citation: Dhareula A, Goyal A, Gauba K, Bhatia SK, Kapur A, Bhandari S. A clinical and radiographic investigation comparing the efficacy of cast metal and indirect resin onlays in rehabilitation of permanent first molars affected with severe molar incisor hypomineralisation (MIH): a 36-month randomised controlled clinical trial. Eur Arch Paediatr Dent. 2019 Oct;20(5):489-500. doi: 10.1007/s40368-019-00430-y. Epub 2019 Mar 19.
citation: Gaton-Hernandez P, Serrano CR, da Silva LAB, de Castaneda ER, da Silva RAB, Pucinelli CM, Manton D, Ustrell-Torrent JM, Nelson-Filho P. Minimally interventive restorative care of teeth with molar incisor hypomineralization and open apex-A 24-month longitudinal study. Int J Paediatr Dent. 2020 Jan;30(1):4-10. doi: 10.1111/ipd.12581. Epub 2019 Oct 24.