Three Restorative Protocols in MIH: a Randomized Controlled Clinical Study

Molar Incisor Hypomineralization Clinical Trial

Official title:

Comparison of Three Restorative Protocols in Teeth With Molar-Incisor Hipomineralization (MIH): a Randomized Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03760497
• Other study ID #: MIHFORPUSP
• Status: Recruiting
• Phase: N/A
• Start date: December 2021
• Est. completion date: December 2021

Study information

• Verified date: September 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Molar-Incisive Hipomineralization (MIH) is defined as a qualitative change in tooth enamel of systemic origin, which affects one or more permanent first molars, and may or may not involve permanent incisors. MIH has several clinical repercussions, such as presence of hypersensitivity, difficulty in local anesthesia, reduction of restorations longevity, among others, making it difficult to perform dental treatment. Therefore, the present study will evaluate, through a randomized controlled clinical study, three restorative protocols for the treatment of severe MIH (with post eruptive enamel fracture and dentin exposure). The following groups will be evaluated: direct restoration with composite resin; restoration with composite resin with diode laser application and temporary restoration with glass ionomer cement followed by restoration with composite resin). The restorations will be evaluated after 1 week, 1, 6, 12, 18 and 24 months. The main outcome will be evaluation of restoration longevity, presence of caries lesion and wear of the restoration surface. Other outcomes such as patient satisfaction with treatment, patient discomfort, anxiety, assessment of dentin sensitivity and impact on participants' quality of life, as well as the duration and cost of treatment, as well as their cost-effectiveness ratio will also be evaluated . Multilevel statistical analyzes will be performed to verify the effectiveness of diode laser treatment compared to sealing, in addition to possible factors associated with this efficacy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

• At least one permanent first molar with occlusal surface with severe MIH grade (with post eruptive enamel fracture and dentin exposure), it may not be reported hypersensitivity in the selected tooth. Exclusion Criteria: -

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

Procedure:
• Restorative treatment
For all groups, first the patients will be submitted to the anesthetic technique indicated with Lidocaine + Epinephrine 1: 100,000 (New DFL, Rio de Janeiro, Brazil), followed by absolute isolation with rubber sheet and metal clamp; then prophylaxis of the selected tooth will be performed with Robson's brush and pumice stone and water, surface washing and drying with cotton balls, removal of carious tissue or affected enamel without dentin support with sharp curettes or low-speed spherical drills. Subsequently, each group will follow the treatment protocols suggested by the manufacturer of restorative materials.

Locations

Country	Name	City	State
Brazil	School of Dentistry of Ribeirao Preto	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longevity of restorations	The main purpose will be the longevity of the desserts in elaborate compounds, according to the three protocols.; Images should be analyzed and scanned. Radiographic examination and digital radiography. After 6, 12 and 24 months.	24 months.
Primary	Treatment satisfaction as assessed by VAS scale (Index 0 to 10)	After 1 week of treatment, 1, 12 and 24 months, the caregiver will be asked to respond about the satisfaction regarding the care (treatment and returns) received. He should classify his satisfaction using the VAS scale with indexes from 0 to 10, with 0 being the worst treatment evaluation and 10 being the best.	After 1 week of treatment, 1, 12 and 24 months.
Primary	Discomfort referred by the children assessed by Wong-Baker Facial Scale (Very smiling to very sad)	In order to assess the discomfort reported by the children in relation to the type of treatment received, the same timekeeping operator will apply the Wong-Baker Facial Scale to the patient, which is composed of six figures with equidistant faces. that the first one is very smiling and the expressions are changing, until the last one is very sad.	On treatment day
Primary	Quality of life assessed by Child Perceptions Questionnaire 8-10 (CPQ8-10) (Assessed by questions)	To assess the impact of MIH on children's quality of life, the Child Perceptions Questionnaire 8-10 (CPQ8-10), specially developed for children aged 8-10 years and validated in the Portuguese language. This scale was assessed through questions and answers to a children's quality of life.	On treatment day
Primary	Anxiety Assessment	For the assessment of anxiety in the study children, the Children's Fear Survey Schedule-Dental Subscale will be used	On treatment day
Secondary	Socioeconomic questionnaire	Information obtained through a socioeconomic questionnaire and questions related to the individual characteristics of the child, such as, for example, fluoride exposure variables, oral hygiene practices and eating habits.	On treatment day
Secondary	Evaluation of the caries experience	Evaluation of the caries experience by the ceo-d / CPO-D indices	On treatment day
Secondary	Presence of biofilm visible	Presence of biofilm visible through the Simplified Oral Hygiene Index in which six surfaces will be used to represent the entire mouth: the vestibular of the first right and left first molars, the lingual of the first right and left first molars, and the vestibular surface of the upper central incisor right and bottom left	On treatment day
Secondary	Evaluation of the visible biofilm accumulated on the occlusal surface	First the presence of dental biofilm will be evaluated visually, according to the following index: 0: absence of visible biofilm; 1: visible but difficult to identify biofilm - best verified after drying; 2: Visible and easily identifiable biofilm - even without drying	On treatment day
Secondary	Evaluation of the presence of visible biofilm on the buccal surfaces of the molars to be evaluated	0: absence of visible biofilm, 1: biofilm not visible, but removed from the gingival sulcus with the periodontal probe; 2: visible biofilm after drying; 3: abundant biofilm, visible even without drying.	On treatment day
Secondary	Assessment of eruption degree	The degree of eruption will be assessed according to the following criteria (5): A: not erupted or less than 1/3 of the erupted occlusal surface or part of the crown of the visible incisor; B: totally erupted or at least 1/3, but less than the total occlusal surface erupted and / or less than the total crown length of the visible incisor.	On treatment day
Secondary	Evaluation of lesion extension	The extent of lesion will be evaluated according to the following criterion (5): I: less than one third of the affected tooth, II: at least 1/3 of the affected tooth, but less than 2/3, III : at least 2/3 of the affected tooth.	On treatment day
Secondary	Cost of procedures	To calculate the direct costs of the procedures, the time spent in each consultation (initials and reevaluations) will be taken into account. The time will be timed and recorded in a specific clinical record. For the calculation of direct costs, the prices of consumer and permanent materials (specifications and quantity) used in each procedure, electricity and the professional fee will be considered. These values will be inferences of the market value obtained by average of different places that market the products in question, being updated during the time of the study. In addition, the cost of equipment depreciation and electricity will be calculated.	On treatment day