Management of Dentin Hypersensitivity in Patients With Periodontitis

Not Applicable

• Conditions: Dentin Hypersensitivity

• Registration Number: NCT07068724
• Lead Sponsor: Trakya University

Brief Summary

A total of 52 patients diagnosed with Stage III-IV periodontitis underwent non-surgical periodontal therapy. At 24 hours post-treatment, patients were recalled to the clinic for reassessment using air-stimulated Visual Analog Scale (VAS) and Schiff Cold Air Sensitivity Scale measurements. Two teeth per patient were randomly selected based on a VAS score greater than 4 and a Schiff score of 2 or 3. A total of 48 patients who met the inclusion criteria were included in the study. This study was designed as a randomized, controlled, parallel clinical trial. The 48 patients were randomly allocated into three treatment groups: Group 1 received the desensitizing agent Gluma, Group 2 underwent Er,Cr:YSGG laser treatment, and Group 3 received a combination of Gluma and Er,Cr:YSGG laser therapy. Desensitizing agent applications were performed according to the designated treatment protocols, with 16 patients in each group.To assess changes in dentin hypersensitivity over time, patients were recalled for follow-up evaluations at 1 week, 2 weeks, 1 month, and 2 months post-application. At each follow-up visit, air-stimulated VAS and Schiff scale measurements were employed to quantify hypersensitivity levels.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study Start: 2025-05-10
• Study First Submitted QC: 2025-07-15
• Last Update Submitted: 2025-07-15
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 1. No reported or clinically detected dentin hypersensitivity prior to the initiation of non-surgical periodontal therapy.

  2. Presence of at least five teeth with probing pocket depths (PPD) ≥6 mm. 3. Systemically healthy individuals with no history of systemic diseases that may interfere with periodontal outcomes.

  3. Absence of deep restorations or visible cracks in the teeth adjacent to those selected for hypersensitivity evaluation.

  4. No previous treatment for dentin hypersensitivity and no current use of desensitizing toothpaste or products.

  5. Clinical diagnosis of Stage III or IV periodontitis, involving periodontal support loss in more than 30% of teeth.

  6. A clinical attachment level (CAL) ≥5 mm and radiographic evidence of bone loss extending to the mid-root level.

  7. Age 18 years or older at the time of enrollment

Exclusion Criteria

• 1. Use of antibiotics or analgesic medications at the time of screening or during the course of the study.

  2. Pregnancy or breastfeeding. 3. Receipt of periodontal therapy within the preceding 6 months. 4. Smoking history of 10 or more cigarettes per day. 5. Regular use of desensitizing toothpaste or other anti-hypersensitivity agents.

  3. Presence of parafunctional oral habits (e.g., bruxism, clenching). 7. Existence of non-carious cervical lesions such as erosion, attrition, or abrasion on study or adjacent teeth.

  4. High frequency of acidic dietary intake. 9. Inability to meet hypersensitivity perception thresholds following non-surgical periodontal therapy, defined as a Visual Analog Scale (VAS) score >4 and Schiff Cold Air Sensitivity Scale score of 2 or 3.

  5. Contraindications to the use of Er,Cr:YSGG laser therapy, including but not limited to: known allergies to local or topical anesthetics, presence of cardiac devices (e.g., pacemakers or implantable defibrillators), respiratory disease, bleeding disorders, or immunosuppressive conditions. In such cases, written clearance from a physician is required.

  6. Known or suspected allergy to any component of the Gluma Desensitizer, specifically hydroxymethyl methacrylate or glutaraldehyde.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decrease in hypersensitivity rate	1 month	Combination of Gluma and Laser application can have an synergistic effect on hypersensitivity rate

Trial Locations

Locations (1)

Trakya University; 🇹🇷 Edirne, Turkey