Dipotassium Oxalate for Postoperative Sensitivity in NCCLs (DIPOX-RCT)

April 18, 2026 updated by: Dr. Muhammad Usama Bin Sharif, Postgraduate Medical Institute, Lahore

Comparative Evaluation of Dipotassium Oxalate in Postoperative Sensitivity Control in Class V Composite Restorations: A Randomized Controlled Trial

Postoperative sensitivity is a common complication following Class V composite restorations, particularly in non-carious cervical lesions (NCCLs). This randomized controlled trial aims to evaluate the effectiveness of dipotassium oxalate as a pre-treatment agent in reducing postoperative sensitivity.

A total of 64 participants will be randomly assigned into two groups: an intervention group receiving dipotassium oxalate prior to adhesive application, and a control group receiving standard adhesive protocol without pretreatment. Sensitivity will be assessed using a Visual Analog Scale (VAS) in response to cold and air stimuli at baseline, 24 hours, 7 days, and 30 days.

The study aims to determine whether dipotassium oxalate significantly reduces postoperative sensitivity and can be incorporated into routine restorative dental practice.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Postoperative sensitivity is a common complaint after Class V composite restorations, particularly in the management of non-carious cervical lesions (NCCLs). These lesions can be caused by various factors (i.e. abrasion, erosion or abfraction) leading to dentin exposure and hypersensitivity due to open dentinal tubules. While modern adhesive systems do improve bonding, they often do not fully address the issue of postoperative sensitivity leading to patient discomfort, thereby demanding a novel approach. Among various desensitizing agents, dipotassium oxalate has shown a significant potential due to its unique ability to form calcium oxalate crystals that occlude dentinal tubules and reduce fluid movement (the main cause of dentinal sensitivity).

This study aims to assess the effectiveness of dipotassium oxalate in controlling postoperative sensitivity in Class V composite restorations of NCCLs. The research question is: "Does the application of dipotassium oxalate prior to adhesive application significantly reduce postoperative sensitivity when compared to the conventional bonding procedure?". The objective of this study is to evaluate and compare postoperative sensitivity between two independent groups-one pretreated with dipotassium oxalate before adhesive application and the other treated using just standard adhesive protocol.

A randomized controlled trial (RCT) shall be conducted with a parallel group design. The sample shall consist of 64 participants, each presenting with at least one NCCL. Pre-operative sensitivity will be assessed using a Visual Analog Scale (VAS) in response to cold test and standardized air-blast . Participants will be randomly assigned to one of the following two groups: the intervention group (receiving dipotassium oxalate treatment before adhesive application) and the control group (receiving adhesive application alone). Non-Probability Convenience sampling will be used to select participants who meet the pre-determined inclusion criteria. Allocation to groups shall be done using a computer-generated randomization sequence with allocation concealment ensured via sealed opaque envelopes.

All restorations will be carried out using a standardized clinical protocol, including cavity preparation (if needed) and restoration using light cured composite resin. Postoperative sensitivity will be assessed using a Visual Analog Scale (VAS) in response to an air-blast (standardized triple-syringe air blast for 5 seconds from a 1 cm distance) and cold stimuli (ethyl chloride spray applied to a cotton pellet placed at the restoration margin for 5-10 seconds) at baseline, 24 hours, 7 days, and 30 days post-restoration. Data will be statistically analyzed using independent t-tests or Mann-Whitney U tests for intergroup comparisons, and repeated measures ANOVA or Friedman test for intragroup time-based analysis.

This study has the potential to validate a simple, affordable, and easily applicable method to deal with postoperative sensitivity in Class V restorations. If found effective, dipotassium oxalate may be adopted in routine clinical protocols, enhancing patient comfort, improving treatment outcomes, and increasing the long-term success of restorations in NCCLs.

Study Type

Interventional

Enrollment (Estimated)

64

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

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000

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

No

Description

Inclusion Criteria:

  • Individuals aged 30 to 45 years.
  • Presence of at least one tooth with a non-carious cervical lesion (Class V) with a lesion depth of ≥1 mm, requiring restorative treatment.
  • The NCCL must show some symptoms/signs of pre-op sensitivity on applying stimulus (i.e Air burst / ethyl chloride spray) and will be recorded.
  • The involved teeth must be vital and show no signs or symptoms of irreversible pulpitis or necrosis.
  • Subjects must be willing to provide written informed consent and commit to the study's follow-up schedule.
  • Subjects with fair to good oral hygiene as determined by a simplified oral hygiene index (OHI-S score ≤2).

Exclusion Criteria:

  • Presence of carious lesions or restored teeth with existing secondary caries
  • Any tooth with pulpal involvement, previous root canal therapy, or periapical pathology.
  • Teeth with chronic periodontal disease( BPE score 3 and above.).
  • Individuals regularly using Desensitizing toothpastes, NSAIDs, antidepressants, or any other pain-modulating drugs that may alter sensitivity reporting.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dipotassium oxalate pretreatment before composite restoration
Participants receive dipotassium oxalate pretreatment before adhesive application and composite restoration.
Combination product: Dipotassium Oxalate Gel
Application of a 3% dipotassium oxalate gel to exposed dentin in non-carious cervical lesions prior to adhesive placement. The material is applied for 90 seconds and gently air-dried without rinsing, following manufacturer instructions. This pretreatment aims to occlude dentinal tubules through calcium oxalate crystal formation before restoration with a standard etch-and-rinse adhesive system and nanohybrid composite resin.
No Intervention: No Dipotassium Oxalate Pre-treatment, Standard composite filling only
Participants receive standard adhesive protocol without dipotassium oxalate pretreatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Sensitivity
Time Frame: 24 hours, 7 days, and 30 days
Measured using a 10-point Visual Analog Scale (VAS) after standardized air blast and cold stimulus. The minimum sensitivity score will be 1, while the maximum sensitivity score will be recorded 10.
24 hours, 7 days, and 30 days

Collaborators and Investigators

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

Sponsor

Postgraduate Medical Institute, Lahore

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)

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-ERC-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Confidentiality

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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