Evaluation of Biomimetic Mineralization Plus Soft Laser Irradiation in Dentin Hypersensitivity Management

Not Applicable

Completed

• Conditions: Dentin Hypersensitivity

• Registration Number: NCT06829277
• Lead Sponsor: MTI University

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.

Study Timeline

• Study Start: 2024-11-01
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-30
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-14
• Study First Posted: 2025-02-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-13
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dentin hypersensitivity	Baseline - 15 minutes- 2 weeks - 1 month - 3 months	Visual Analogue Scale (VAS) will be used by which 0 is no pain and 10 is severe pain. Pictures are added to the same, as well as colors to guide the patient during selection of pain severity.; The VAS scale (0-10) is the recommended tool used to evaluate pain of dentin hypersensitivity, and it is the most commonly used in most of the clinical trials. The patient should point out the degree of sensitivity on the VAS scale (0-chart the degree of pain. (VAS \>4). A plastic card with figures of facial expressions expressing the degree of pain, color-coded, and numbers guided will be used to ease the process of figuring out the degree of pain. These cards are also useful in standardizing the assessment method for the patient throughout the study and taking records without any verbal or emotional guidance from the assessors.
A- Tactile test	Baseline - 15 minutes- 2 weeks - 1 month - 3 months	By explorer
B- Evaporative test	Baseline - 15 minutes - 2 weeks- 1 month - 3 months	By air syringe
C- Thermal Test	Baseline - 15 minutes - 2 weeks- 1 month - 3 months	By refreigent spray

Secondary Outcome Measures

Name	Time	Method
Salivary Ph assessment	Baseline - 15 minutes- 2 weeks - 1 month - 3 months	All participants will be instructed not to eat or drink at least one hour before collecting saliva. Before collecting saliva, patients will be asked to rinse with water and then wait for two minutes for water clearance. Unstimulated saliva will be collected by making the subjects sit upright with the head slightly inclined. The passively drooled saliva will be collected on the floor of the mouth and then will be expectorated into graduated saliva collecting vials. pH will be measured using a pH meter (Adwa Instruments, Inc., Szeged, Hungary) reading from 0 to 14 (acidic pH \< 7 and alkaline pH \> 7 and neutral = 7).

Trial Locations

Locations (1)

Mti university; 🇪🇬 Cairo, Egypt