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Not yet recruitingNCT07540299DIPOX-RCTUpdated Apr 22, 2026

Dipotassium Oxalate for Postoperative Sensitivity in NCCLs

An interventional study of Dipotassium Oxalate Gel in Dentin Hypersensitivity, Post Operative Sensitivity Control, sponsored by Postgraduate Medical Institute, Lahore. Not yet recruiting at 1 site in Pakistan. Open to participants aged 30 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Postgraduate Medical Institute, Lahore · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
30 Years to 45 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Dentin Hypersensitivity, Post Operative Sensitivity Control

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Keywords

  • Dipotassium Oxalate
  • Postoperative Sensitivity
  • Composite Restoration
  • NCCL
  • Dentin Hypersensitivity
03

In context

Dentin Sensitivity

288 studies on the registry are indexed under Dentin Sensitivity; 46 are open to participants now.

This study's planned enrollment of 64 is close to the median of 60 across 279 interventional studies indexed under Dentin Sensitivity.

Browse Dentin Sensitivity studies →

Lead sponsor

Postgraduate Medical Institute, Lahore is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    Dipotassium oxalate pretreatment before composite restoration

    Participants receive dipotassium oxalate pretreatment before adhesive application and composite restoration.

    Combination Product: Dipotassium Oxalate Gel

  • No intervention
    No Dipotassium Oxalate Pre-treatment, Standard composite filling only

    Participants receive standard adhesive protocol without dipotassium oxalate pretreatment.

Interventions

  • Combination productDipotassium 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.

06

What researchers measure

Primary outcomes

  1. Postoperative Sensitivity

    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.

    Time frame: 24 hours, 7 days, and 30 days

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided — Confidentiality

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Sep 2026, 3 months later.

Of 111 non-industry interventional studies with no phase under Dentin Sensitivity, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 12. This study's planned 3 months is below that.

Counting every sponsor, half of 144 studies reached it within 6 months; a quarter within 3 and three quarters within 10.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2026
First posted
Apr 20, 2026
StartEst.
Jun 1, 2026
Primary completionEst.
Sep 1, 2026
CompletionEst.
Oct 1, 2026
Last update
Apr 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07540299
Lead sponsor
Postgraduate Medical Institute, Lahore
Responsible party
Dr. Muhammad Usama Bin Sharif (Principal Investigator, Postgraduate Medical Institute, Lahore) — Principal investigator
First posted
Apr 20, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
Sep 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Apr 22, 2026

Study contacts

Muhammad Usama Bin Sharif BIN SHARIF, BDS
Contact
osamasharif06@gmail.com
+92 3124244476

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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