Clinical trial NCT06829277: Evaluation of Biomimetic Mineralization Plus Soft Laser Irradiation in Dentin Hypersensitivity Management
Official title: Efficacy of Biomimetic Mineralization Approach Plus Soft Laser Irradiation in Management of Dentin Hypersensitivity: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Hypersensitivity
Keywords: Curodont de senz
Laser
Fluoride varnish
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial to investigate the efficacy of diode laser , Biomimetic mineralization desensitizing agents Curodont D'Senz (CS) gel both in combination and alone, and the efficacy of bifluoride 10 (5 % sodium fluoride) varnish alone in cervical dentin hypersensitivity patients. Also, to assess the duration of sensitivity relief immediately after 15 minutes of application, after 2 weeks, after 1 month and 3 months , the null hypothesis that there will be no difference between the treatment groups in different times.

Detailed description: Current research focuses on increasing the mineral density of the dentin surface making it possible to improve its resistance to wear by both acid erosion and abrasion and plugging and sealing open tubules with a calcium and phosphate containing dentin-like substance, which would block diffusion through the tubules into the dentin sub-surface, thereby increasing acid resistance. Self-assembling peptide matrix (P11-4) supplied commercially as Curodont D'Senz (CS) gel (Credentis AG, Windisch, Switzerland) is based on the nanofiber technology that enhances biomimetic repair and the remineralization of dental tissues. Self-assembling peptide matrix hydrogel revealed more reduction of the opened dentinal tubules in comparison to other selected desensitizing toothpaste.lasers have been recently been introduced as another possibility for in-office treatment of DH and may open up new horizons in the treatment of dentin hypersensitivity. Of interest is the fact that the laser irradiation can augment the effect of the desensitizer for a longer duration than when they are used alone. They hypothesized that laser favor the durability of the desensitizer for extended time. Some studies recommend desensitizing agent to remain above tooth surface for one minute before laser irradiation.

Eligibility criteria: Inclusion Criteria:

* Age from 18-60 years old.
* Non-smokers.
* Disease-free patients.
* Good oral hygiene.
* Having at least one teeth suffering from cervical dentin hypersensitivity with VAS pain score ≥5
* Recording pain to thermal, mechanical or tactile stimuli.
* Acceptance to participate in the study

Exclusion criteria:

* Smoking and bad oral hygiene.
* Presence of carious lesions, restorations or fracture in the test area.
* Presence of painful pathology restored less than three months in the test area.
* Using any desen¬sitizing agents.
* Undergo any peri¬odontal surgery in the last 6 months.
* Drug abusers.
* Administration of potent analgesics or anti-inflammatory drugs.

Primary outcomes:
measure: Dentin hypersensitivity
timeFrame: Baseline - 15 minutes- 2 weeks - 1 month - 3 months
measure: A- Tactile test
timeFrame: Baseline - 15 minutes- 2 weeks - 1 month - 3 months
measure: B- Evaporative test
timeFrame: Baseline - 15 minutes - 2 weeks- 1 month - 3 months
measure: C- Thermal Test
timeFrame: Baseline - 15 minutes - 2 weeks- 1 month - 3 months
Secondary outcomes:
measure: Salivary Ph assessment
timeFrame: Baseline - 15 minutes- 2 weeks - 1 month - 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mti university
Study officials:
affiliation: MTI University
name: Aalaa M nabil, Lecturer
role: STUDY_CHAIR
affiliation: MTI University
name: Ahmed M Sayed, Assis. prof.
role: STUDY_DIRECTOR
References: