Effect of Gluma and Bioactive Glass Desensitizers in Treatment of Dentin Hypersensitivity in Cervical Non-Carious Lesions

NCT07063433 | Completed

• 1 other identifier: 24-012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Type of study: (A Randomized Controlled Clinical Trial) Aim :The aim of this randomized controlled clinical trial is to evaluate the effect of Gluma, Bioactive Glass and combination of both, compared to Flouride Varnish on the treatment of dentin hypersensitivity of cervical non-carious lesions in adult Population over six months. The study will enroll 40 patients meeting the inclusion criteria. Each patient will contribute one tooth with complaints that meet the inclusion criteria, resulting in a total of 40 included teeth. The teeth will be categorized into Four groups based on the type of desensitizer used.

• Group 1 (G1); patients will be randomly assigned to Gluma.
• Group 2 (G2); patients will be randomly assigned to Bioactive Glass Powder.
• Group 3 (G3); patients will be randomly assigned to combination of both materials, Gluma and Bioactive Glass powder
• Group 4 (G4); patients will be randomly assigned to the Fluoride Varnish. For each patient, a sensitivity test will be conducted using a Visual Analog Scale immediately after desensitizer application, as well as at three months and six months post-application. Clinical procedures: The study will involve applying a controlled air stimulus (evaporative) to the complaining tooth. This will be done using a dental syringe adjusted to 40-65 psi, directed perpendicular at a distance of 1-3 mm from the exposed dentin. Subsequently, the patient will indicate the level of sensitivity on a Visual Analog Scale (VAS) chart ranging from 0 to 10, with a focus on instances where the VAS score exceeds 4. To facilitate the patient's expression of pain intensity, a plastic card featuring figures with facial expressions, color-coded, and numbered, will be utilized. This visual aid aims to streamline the process of discerning and recording the degree of pain experienced by the patient. For Gluma group Each sensitive tooth will be cleaned with a polishing paste, rinsed with water and air dried. Two coats of Gluma Desensitizer will be applied using a disposable brush applicator following the manufacturer's instructions and left untouched for 30-60 minutes. For Bioactive Glass group : To maintain a dry and clear field of vision, cheek retractors and high-volume suction will be employed during the procedure. High-volume suction, featuring a 45-degree beveled end, will be strategically positioned at the incisal or occlusal part of the teeth. This placement is designed to efficiently remove any particles, preventing the patient from swallowing them and minimizing the risk of minor injuries resulting from a forceful powder and water stream. The NSK Prophymate Neo will be utilized to dispense Sylc dry powder, which comprises calcium sodium phosphosilicate, onto the sensitive areas. The air stream will be carefully adjusted to 40-46 psi in accordance with the manufacturer's instructions. The handpiece will be maintained at a constant distance of 3-4 mm from the tooth surface, positioned at 60-80 degrees on the buccal surfaces. To prevent gingival injury, the tip of the handpiece will be directed incisally during application. The powder will be applied for 5-10 seconds per tooth, using a circular motion. For the combined group (Bioactive Glass + Gluma) A combination of both Gluma and bioactive glass powder will be applied to the assigned teeth. For the comparator group : The teeth will undergo a thorough cleaning process using a polishing brush without any paste, and the surfaces will be subsequently air-dried. The application of a single dose of Bifluorid 10 (by VOCO) will be carried out using a micro brush. A thin coat of varnish will be applied to the tooth surface, and it will be left in place for 10-20 seconds before being air-dried. This procedure is designed to facilitate the effective application of the desensitizing agent.

Conditions

Dentin Hypersensitivity

Keywords

dentin hypersensitivity; gluma; Bioactive glass; fluoride varnish; VAS; non carious lesions; cervical non carious lesions

Outcome Measures

Primary Outcomes (1)

• Post-operative hypersensitivity assessment using Visaul

  Post-operative hypersensitivity assessment will be conducted immediately after application, as well as at three months and six months post-treatment. The evaluation will utilize the Visual Analog Scale (VAS) as described by Van den Breemer et al. (2019) . This scale is represented by a horizontal line graded from 1 to 10, with a descriptor at its far-left end indicating no pain and at its far-right end indicating the worst possible pain. Additionally, facial expressions with color codes will be illustrated below the 10-centimeter line on the Visual Analog Scale, as outlined by Burrow et al. (2009). This approach provides a comprehensive and visual means for patients to express and quantify their post-operative hypersensitivity levels.

  From enrollment to the end of treatment at 6 months .

Study Arms (4)

Gluma Group

ACTIVE COMPARATOR

Each sensitive tooth will be cleaned with a polishing paste, rinsed with water and air dried. Two coats of Gluma Desensitizer will be applied using a disposable brush applicator following the manufacturer's instructions and left untouched for 30-60 minutes.

Drug: Gluma Desensitizer

Bioactive Glass Group

ACTIVE COMPARATOR

To maintain a dry and clear field of vision, cheek retractors and high-volume suction will be employed during the procedure. High-volume suction, featuring a 45-degree beveled end, will be strategically positioned at the incisal or occlusal part of the teeth. This placement is designed to efficiently remove any particles, preventing the patient from swallowing them and minimizing the risk of minor injuries resulting from a forceful powder and water stream. The NSK Prophymate Neo will be utilized to dispense Sylc dry powder, which comprises calcium sodium phosphosilicate, onto the sensitive areas. The air stream will be carefully adjusted to 40-46 psi in accordance with the manufacturer's instructions. The handpiece will be maintained at a constant distance of 3-4 mm from the tooth surface, positioned at 60-80 degrees on the buccal surfaces. To prevent gingival injury, the tip of the handpiece will be directed incisally during application. The powder will be applied for 5-10 seconds pe

Drug: Bioactive glass

Combination of Gluma and Bioactive glass

ACTIVE COMPARATOR

A combination of both Gluma and bioactive glass powder will be applied to the assigned teeth.

Drug: Gluma Desensitizer; Drug: Bioactive glass

Fluoride Varnish

ACTIVE COMPARATOR

The teeth will undergo a thorough cleaning process using a polishing brush without any paste, and the surfaces will be subsequently air-dried. The application of a single dose of Bifluorid 10 (by VOCO) will be carried out using a micro brush. A thin coat of varnish will be applied to the tooth surface, and it will be left in place for 10-20 seconds before being air-dried. This procedure is designed to facilitate the effective application of the desensitizing agent.

Drug: Fluoride varnish

Interventions

Bioactive glass DRUG

The NSK Prophymate Neo will be utilized to dispense Sylc dry powder, which comprises calcium sodium phosphosilicate, onto the sensitive areas. The air stream will be carefully adjusted to 40-46 psi in accordance with the manufacturer's instructions. The handpiece will be maintained at a constant distance of 3-4 mm from the tooth surface, positioned at 60-80 degrees on the buccal surfaces. The powder will be applied for 5-10 seconds per tooth, using a circular motion.

Also known as: Sylc

Bioactive Glass Group; Combination of Gluma and Bioactive glass

Fluoride varnish DRUG

The application of a single dose of Bifluorid 10 (by VOCO) will be carried out using a micro brush. A thin coat of varnish will be applied to the tooth surface, and it will be left in place for 10-20 seconds before being air-dried.

Also known as: Bifluorid 10

Fluoride Varnish

Gluma Desensitizer DRUG

Each sensitive tooth will be cleaned with a polishing paste, rinsed with water and air dried. Two coats of Gluma Desensitizer will be applied using a disposable brush applicator following the manufacturer's instructions and left untouched for 30-60 minutes.

Combination of Gluma and Bioactive glass; Gluma Group

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient's age ranges from 21- 40 years old.
• Males or Females
• Co-operative Patients approving the trial.
• Good oral hygiene
• Not received antibiotic therapy for 1 month before sampling

You may not qualify if:

• Lack of compliance
• Patients with bad oral hygiene
• Patients who are allergic to any ingredients used in the study.
• Medically compromised patients with systemic complications that would alter the treatment.
• Patients who did any periodontal surgeries within the previous 6 months.
• Inability to give informed consent.
• Xerostomia.
• Pregnancy

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British University in Egypt

Cairo, Elshorouk City, 4914085, Egypt

Location

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

gluma desensitizer

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 14, 2025
• Study Start: February 3, 2025
• Primary Completion: May 22, 2025
• Study Completion: November 15, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

EG (1)