Dentin Hypersensitivity in Orthodontic Patients: Triple-Blinded, Randomized Trial of Three Desensitizing Agents.

June 7, 2026 updated by: Fatima Khalid, Nishtar Medical University

Dentin Hypersensitivity: Triple-Blinded, Multicenter Randomized Trial of Three Desensitizing Dentifrices vs Non-Desensitizing Control

The effect of desensitizing agents will be studied on dentin hypersensitivity in orthodontic patients.it is a randomized controlled trial. three experimental groups and one placebo group.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Orthodontic patients aged 18-40 years.
  • Presence of mild to moderate dentin hypersensitivity (VAS ≥ 4).
  • Willingness to comply with a 12-week follow-up period.
  • No active periodontal disease or untreated caries.
  • Not pregnant or breastfeeding.
  • No history of allergy to desensitizing agents

Exclusion Criteria:

  • o Patients with systemic conditions affecting oral health (e.g., diabetes, immunocompromised).

    • Patients using medications that affect tooth sensitivity (e.g., anti-inflammatory drugs).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEST TOOTHPASTE GROUP 1
Participants in this arm will use the test toothpaste twice daily for 8 weeks.
Other: TOOTH PASTE(NHA)
TOOTH PASTES CONTAINING NHA.
Active Comparator: TEST TOOTH PASTE GROUP 2
Participants in this arm will use the test toothpaste twice daily for 8 weeks.
Other: TOOTH PASTE (NOVAMIN)
TOOTH PASTE CONTAINING NOVAMIN
Active Comparator: TEST TOOTH PASTE GROUP 3
Participants in this arm will use the test toothpaste twice daily for 8 weeks.
Other: TOOTH PASTE (PROARGIN)
TOOTH PASTE CONTAINING PROARGIN.
Placebo Comparator: TEST TOOTH PASTE GROUP 4
Participants in this arm will use the test toothpaste twice daily for 8 weeks.
Other: TOOTH PASTE ( NON DESENSITIZING)
TOOTH PASTE A NON-DESENSITIZING CONTROL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
REDUCTION IN DENTIN HYPERSENSITIVITY
Time Frame: 8 WEEKS
Change in dentin hypersensitivity scores from baseline to 8 weeks using the Visual Analog Scale (VAS) and Schiff Cold Air Sensitivity Scale.
8 WEEKS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nishtar Medical University

Investigators

  • Study Chair: Dr. Zubair Hassan Awaisi, FCPS, PRINCIPAL NID MULTAN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

June 7, 2026

First Submitted That Met QC Criteria

June 7, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 7, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • room 203 fk orthodontics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IM NOT COMFORTABLE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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