Clinical trial NCT04407702: Control of Pain Due to Dentin Hypersensitivity in Individuals With Molar-incisor Hypomineralization
Official title: Control of Pain Due to Dentin Hypersensitivity in Individuals With Molar-incisor Hypomineralization: Study Protocol for a Randomized, Controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Dentin Sensitivity
Molar Incisor Hypomineralization
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Dentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: 1) the dentin must be exposed and 2) the dentinal tubules must be open and connected to the pulp. Molar-incisor hypomineralization (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The control of tooth sensitivity is fundamental to the successful treatment of MIH.

Objective: The aim of the proposed randomized, controlled, clinical trial is to evaluate the effectiveness of different protocols for the control of DH in patients with teeth affected by MIH.

Methods: One hundred forty patients who meet the inclusion criteria will be allocated to four groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be sealed with Permaseal (Ultradent). In Group 3, sensitive teeth will receive low-level laser (LLL) (AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil). In Group 4, sensitive teeth will be treated with both LLL and Permaseal (Ultradent). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated one week, one month, three months and six months after the treatments.

Discussion: This study will enable the determination of differences in the effectiveness of the proposed treatments as well as differences among the evaluation times for each proposed treatment.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 35 years;
* Good overall health;
* At least one tooth with MIH and DH reported in the cervical region with sensitivity equal to or greater than 4 on the VAS.

Exclusion Criteria:

* Active caries or defective restorations on the tooth to be analyzed;
* Sufficient dentin loss that requires restorative treatment or periodontal surgery;
* Having undergone any professional desensitizing treatment in the previous six months;
* Having used a desensitizing paste in the previous three months;
* Use of anti-inflammatory drugs or analgesics at the time of recruitment;
* Currently pregnant or nursing.

Primary outcomes:
measure: Change in pain evaluated through a Visual Analog Scale (VAS)
timeFrame: Baseline, one week, one month, three months and six months after the final treatment session.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sobral APT, Santos EM, Aranha AC, Soares PV, Moriyama CM, Goncalves MLL, Ribeiro RA, Motta LJ, Horliana ACRT, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. The control of pain due to dentin hypersensitivity in individuals with molar-incisor hypomineralisation: a protocol for a randomised controlled clinical trial. BMJ Open. 2021 Mar 10;11(3):e044653. doi: 10.1136/bmjopen-2020-044653.