Comparative Clinical Evaluation of Partial Coverage CAD/CAM Restoration Versus Nanohybrid Composite of Carious Hypomineralized Permanent Molars: A Randomized Controlled Trial
Phase: NA
Conditions: Molar Incisor Hypomineralization
Sponsor: October University for Modern Sciences and Arts

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Official Title of the Study:  
Comparative Clinical Evaluation of Partial Coverage CAD/CAM Restoration Versus Nanohybrid Composite of 
Carious Hypomineralized Permanent Molars: A Randomized Controlled Trial  
NCT Number: Not yet assigned  
Date of the Document: December 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Comparative Clinical Evaluation of Partial Coverage  
CAD/CAM Restoration Versus Nanohybrid Composite of 
Carious Hypomineralized Permanent Molars: A Randomized 
Controlled Trial.  
  
 
 
التقييم السريري المقارن للتغطية الجزئية لترميم 
CAD/CAM
                      
 مقابل مركبNanohybrid
 
 من األضراس الدائمة ناقصة المعادن: تجربة 
 .عشوائية محكومة 
 
 
 
  
 
Protocol checklist  
 
 
Section and topic  
Item no.  
Checked item  
Reported 
on page No.  
Reviewer’s 
check  
   
I. Administrative information  
1  
Title  
 
 
2  
Protocol registration  
 
 
3  
Protocol version  
 
 
4  
Funding  
 
 
5  
Roles and responsibilities  
 
 
  
 
 
 
II. Introduction  
 
 
 
  
  
A) Background and Rationale  
 
6 a  
Research question  
 
 
Statement of the problem  
 
 
Rationale for carrying out the trial   
 
Review of literature  
 
 
6 b  
Choice of comparators  
 
 
  
B) Objectives  
 
7  
Aim of the study  
 
 
Hypothesis  
 
 
Primary and secondary objectives  
 
 
C) Trial design  
8  
Trial design  
 
 
  
 
 
 

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III. Methods  
 
 
 
  
  
A) Participants, interventions  
& outcomes  
9  
Study setting  
 
 
10  
Eligibility criteria  
 
 
11  
Interventions  
 
 
12  
Outcomes  
 
 
13  
Participant timeline  
 
 
14  
Sample size  
 
 
15  
Recruitment  
 
 
B) Data collection, management, 
and analysis  
16  
Data collection methods  
 
 
17  
Data management  
 
 
18  
Statistical methods  
 
 
  
C) Monitoring  
19  
Data monitoring  
 
 
20  
Harms  
 
 
21  
Auditing  
 
 
  
 
 
 
  
  
  
IV. Ethics and dissemination  
22  
Research ethics approval  
 
 
23  
Protocol amendments  
 
 
24  
Informed Consent  
 
 
25  
Confidentiality  
 
 
26  
Declaration of interests  
 
 
27  
Access to data  
 
 
28  
Ancillary and post-trial care  
 
 
29  
Dissemination policy  
 
 
  
 
 
 
  
  
  
V. Appendices  
30  
Informed consent materials  
  
  
  
31  
Biological specimens  
  
  
  
VI. References  
  
  
  
  
  
 
Evidence based committee (Reviewers)  
 
Name  
Signature  
Date  
1.  
  
  
2.  
  
  
  
 
Research plan committee  

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Name  
Signature  
Date  
1.  
  
  
2.  
  
  
 Administrative information:  
1. Title:  
Comparative Clinical Evaluation of Partial Coverage CAD/CAM Restoration Versus 
Nanohybrid Composite of Carious Hypomineralized Permanent Molars: A Randomized 
Controlled Trial.  
  
2. Protocol Registration:  
  
3. Protocol version:  
  
4. Funding: Self-funded  
  
University Responsibilities: All contribute in initiated the study design, will generate random sequence, 
contribute in clinical work, provide statistical expertise in clinical trial design and make the final edited 
of the article.  
II. Introduction:  
5. Background and rationale:  
      
Hypomineralization of carious permanent molars is defined as qualitative defects caused by disruptions 
in either the calcification or maturation phases of amelogenesis. (1)  
  
Statement of the problem:   
Conventionally, stainless steel crowns were used for those molars. However, due to the need for 
esthetics and the young age of patients, it was necessary to look for a cosmetic and conservative 
restoration alternative. (2) Partial coverage restorations were recommended as a substitute for crowns to 
maintain teeth healthy. It is considered a minimally invasive approach. (3)  
  
The rationale for conducting the research:  
  
Conventional restoration for such hypomineralized molars necessitates massive removal of the 
tooth structure to receive full coverage crowns that cause more biologically harmful consequences like 
pulp exposure especially in young permanent teeth and aggressive tooth structure loss (4). To fulfill the 
biological criteria for tooth preparation, conservatism is the major notion and goal that dental 
practitioners strive to achieve. Nowadays, minimally invasive techniques are frequently employed to 

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support this idea. To meet the growing need for conservative and esthetics tooth restorations, partial 
coverage ceramic restorations are becoming more necessary. These CAD/CAM restorations show 
satisfactory mechanics, restoring function, and esthetic with preserving tooth structure (5)  
Since all materials used to treat such cases have distinct chemical compositions, they have 
different properties that affect their clinical outcome. Therefore, it is essential to compare them clinically 
because any restoration’s clinical outcome affects its long-term success. According to the null 
hypothesis, different materials would not significantly affect the clinical result of ceramic overlay 
restorations.  
Patients in all groups will receive a minimally invasive restoration with high esthetic advantages 
(Protection of the weak cusps and elimination of carious lesions with an esthetic way out) and long-term 
success of their affected carious hypomineralized permanent molars (IPS e.max CAD or Direct 
nanohybrid flowable composite) that require minimal preparation depends on the type of restoration will 
receive.  
  
Aim of the study:  
This randomized controlled trial study will evaluate the clinical success of direct nanohybrid flowable 
composite versus IPS e.max CAD Partial Coverage.  
  
Research question:  
Are the direct nanohybrid flowable composite and IPS e.max CAD Partial Coverage clinically successful 
materials in restoring the carious Hypomineralized Permanent Molars?  
  
PICOS:  
P: Patients suffer from hhypomineralized permanent molars   
I: Direct nanohybrid flowable composite  
C: IPS e.max CAD  
O: Clinical Success (aesthetics, functional and biological criteria))  
  
II. Methods  
  
Study Design:  
Study design:  
Randomized Controlled Trial  
Estimated Enrolment:  
48 Carious Hypomineralized Permanent Molars 
Allocation:  
Randomized   
Intervention Model: Parallel Assignment  
Primary Purpose: Restorations Hypomineralized Permanent Molars  

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Official Title: Comparative Clinical Evaluation of Partial Coverage CAD/CAM Restoration Versus Nanohybrid 
Composite of Carious Hypomineralized Permanent Molars: A Randomized Controlled Trial.  
  
Estimated Study Start Date: December 2023 [Time frame: 12 months] Estimated Primary 
Completion Date: January 2025  
  
Trial design:  
The study is a randomized controlled trial (RCT) where 2 arm parallel groups with a 1:1 allocation 
ratio were compared. The child participants and the legal guardian of each participating child and the 
statistician were blinded.  
Outcome Measures:  
1. Primary outcome: Clinical success [Time Frame: 12 months].   
• 
According to FDI World Dental Federation criteria [Appendix A]  
• 
There were three assessment categories (aesthetics, function, and biological), each with 
five subcategories. From best to worst, the subcategories were:  
(1) clinically excellent, (2) clinically good, (3) clinically sufficient, (4) clinically not 
sufficient but repairable, and (5) clinically unacceptable. Assessment with category (5) 
was rated as a clinical failure.  
• 
At the follow-up visits over one year at (baseline ‘‘1 day ‘‘, 6 and 12 months) after 
cementation., will take standardized photographs and the restorations will clinically 
evaluate by an independent and calibrated clinician.   
  
  
  
Eligibility Criteria  
Ages Eligible for Study:    
Above 6 Years      
Sexes Eligible for Study:    
All  
Accepts Healthy Volunteers:    
Yes  
Criteria  
Inclusion Criteria:  
1. Above 6 years old  
2. Cooperative children with large carious First Permanent Molars (FPM) lesions associated with 
weak cusps and defected hypo-mineralized enamel.  
3. Apparently healthy patients.   
4. Patients will be available to be clinically reviewed up to 1 year  

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Exclusion Criteria:  
1. Patients with Symptoms of pulpitis.  
2. Patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth 
and bleeding on probing).  
3. Poor oral hygiene and motivation.   
4. Patients with parafunctional habits (e.g., bruxism, biting on hard objects).  
5. Patients with debilitating illnesses or complicating medical conditions  
  
  Explanation regarding the choice of comparators:  
  
IPS e.max CAD: Till now, glass–ceramic-based restorations still offer the best translucency and 
esthetic qualities. The novel generation of lithium disilicate-based materials as IPS e.max CAD 
provides standard thickness and quick fabrication. Moreover, the adhesive technique used with this 
restoration type significantly raises its mechanical properties. (6)  
Beautifil Flow Plus X (Shofu)is a bioactive flowable nano-hybrid restorative with a newly developed 
patented nanofiller. It is indicated for all classes including occlusal and cusp. It has all the Giomer 
Technology attributes, anti-bacterial, acid neutralization, and fluoride release and recharge, with 
improved handling and effortless polishing, and maintains a long-lasting shine. Beautifil Flow Plus X 
has the strength, durability, and aesthetics of a hybrid composite. (7)  
  
Sample size (Power analysis):  
  
Sample size calculated depending on a previous study (Alaa M. Eldehna a et al., 2023) as reference. (8) 
According to this study, the probability of surface gloss as an aesthetics criterion in group 1 is 0.96. If 
the estimated probability of group 2 is 0.6, we will need to study 20 cases in each group with probability 
(power) 0.8. The Type I error probability. We used the chi-squared test to evaluate that was performed 
by using P.S.Power 3.1.6. Total sample size increased to 24 subjects per group to compensate for a 15 
% drop out. Sample size calculation was achieved using chi-squared test to evaluate that was performed 
by using P.S. Power3.1.6, software Version 3.1.2 (Vanderbilt University, Nashville, Tennessee, USA). 
Statistical Methods  
Statistical analysis:  
Data was collected, tabulated, and statistically analyzed using Microsoft Excel ® 2016, Statistical 
Package for Social Science (SPSS)® Ver. 24. And Minitab ® statistical software Ver. 16.  
Handling of numerical / quantitative variables:  
Numerical data will be explored for normality by checking the data distribution using Kolmogorov- 
Smirnov and Shapiro-Wilk tests. Data will be presented as mean & amp, standard deviation. If data will 

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be normally distributed comparison between 2 different groups will be performed by using independent 
t-test, comparison between 2 related groups will be performed by using Paired t-test, while comparison 
between more than 2 groups will be performed by using One Way ANOVA test followed by Tukey`s 
Post Hoc test for multiple comparisons. If data will be non-parametric data comparison between 2 
different groups will be performed by using Mann-Whitney test, comparison between 2 related groups 
will be performed by using Wilcoxon Signed Rank test, while comparison between more than 2 groups 
will be performed by using Kruskal-Walli’s test.  
Handling of categorial / qualitative variables:  
Data will be presented as frequency and percentages. All comparisons will be performed 
by using Chi square test.  
Recruitment:  
The study will be conducted at the pediatric dentistry department of MSA University pediatric 
outpatients. All subjects will be monitored and reviewed at day 1 after 6 months and 12 months.  
Post-trial care  
• 
Oral hygiene instructions and serving brush and toothpaste  
• 
Dietary recommendations  
  
Patients Guardians Consent and Ethical Approval  
An informed Consent will be read in detail, explained and signed by the patients’ guardians and will 
make sure that all risk expectations are well understood along with benefits and expected outcomes of 
this clinical research trial to the patient’s well-being. The consent will authorize a treatment plan aimed 
at a mutually acknowledged treatment goal.  
[Appendix B]  
Ethical Approval Number: 
 
 
 
 
 
 
 
 
 
 
 
 

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III. References  
1. 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. European Archives of Paediatric Dentistry. 2019 
Oct;20:489-500.  
2. De Leon, F.M., Garza, N., Coronado, J., Ancona, M., 2022. Indirect ceramic overlay restorations 
as a minimally invasive alternative for posterior rehabilitation. Inter. J. App. Dent. Sci. 8, 79– 
83.  
3. Schiffenhaus, S., 2021. The Nonretentive Ceramic Overlay. A biomimetic alternative to the full 
coverage crown. Ins. Dent. J. 17, 24–31.   
4. Linner, T., Khazaei, Y., Bu¨cher, K., Pfisterer, J., Ku¨hnisch, J., 2020. Comparison of four 
different treatment strategies in teeth with molar-incisor hypomineralization-related enamel 
breakdown—A retrospective cohort study. Int. J. Paediatr. Dent. 30, 597–606.  
5. Mohammed, Z., Majeed, M., 2020. Effect of cementation protocol on the marginal adaptation of 
indirect overlay restorations fabricated from two different all-ceramic CAD/CAM materials. J. 
Res. Med. Dent. Sci. 8, 518–525.  
6. Phark JH, Duarte Jr S. Microstructural considerations for novel lithium disilicate glass ceramics: 
A review. Journal of Esthetic and Restorative Dentistry. 2022 Jan;34(1):92-103.  
7. Pinto NS, Jorge GR, Vasconcelos J, Probst LF, De-Carli AD, Freire A. Clinical efficacy of 
bioactive restorative materials in controlling secondary caries: a systematic review and network 
meta-analysis. BMC Oral Health. 2023 Dec;23(1):1-20.  

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8. Eldehna AM, Montaser AG, ALrafee SA, Abdelgawad A. Clinical outcome of CAD/CAM 
overlays of MIH affected young permanent molars. The Saudi Dental Journal. 2023 Sep 
1;35(6):699-706.  
  
 
 
 
 
 
 
 
 
 
 
 
  
Appendices  
Appendix A: FDI World Dental Federation criteria  

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[Appendix B]: Informed consent  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 Scientific Research Ethics Committee 
Informed Consent for Volunteers 
Research Title: 
Comparative Clinical Evaluation of Partial Coverage CAD/CAM Restoration Versus Nanohybrid Composite of 
Carious Hypomineralized Permanent Molars: A Randomized Controlled Trial  
 
Objective of the Research: 
This randomized controlled trial study will evaluate the clinical success of direct nanohybrid flowable 
composite versus IPS e.max CAD Partial Coverage.  
 
Introduction and Details of What Will Be Performed on the Patient 
(Work plan) 
- Direct benefit to the volunteer 
- Scientific benefits and general expected benefits from the research 
- Side effects, risk level, expected occurrences, and how to handle them 
- Patient duties regarding oral and dental health care during the research/study 
[ ] Full understanding of the patient regarding the research steps: 
    [ ] Reading 
    [ ] Verbal explanation 
I have carefully reviewed and understood the purpose of the research and the nature of this study. I understand 
what is required to complete these procedures. 
1. The research doctor has informed me of possible alternative treatments to this research. 
2. The research doctor has informed me of all potential risks of this research and how to handle them. 
3. I agree to photography, recording, and all types of radiographs required in this study, provided that my identity 
will not be disclosed. 
4. I have provided an accurate report about my health history. I have informed the doctor of all types of health 
reactions or unusual allergies to medications, foods, insect stings, anesthetics, dust, or any other materials, or 
abnormal bleeding, or any other conditions related to my health. 
5. I declare that I am not participating in any other research from the start of this study until its end, and I will 
inform the research doctor if I participate in any other research during this study. 
6. I pledge to return any medical equipment (tools) used in the research if I stop or upon completion of the 
research. 

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After being informed of the available information regarding the research, the volunteer or their guardian is free to 
choose whether or not to participate. If they agree, they are requested to fill in the data below, knowing that they 
have the right to withdraw from the research at any time without giving reasons, with due regard for the 
researcher’s right to retrieve any medical devices or tools used for research purposes that are in the volunteer’s 
possession (as required by the researcher). 
Volunteer’s Name: 
Date of Birth: 
National ID (if available): 
Guardians or companion’s name (if applicable): 
National ID: 
Address: 
Phone: 
Date: 
The physician responsible undertakes to maintain the confidentiality of the volunteer’s information in the 
research, mentioning the methods used for this, such as replacing names with coded numbers or hiding facial 
features in photographs where possible, etc. 
Researcher’s signature: