Dentin Hypersensitivity, Post Operative Sensitivity ControlDIPOX-RCTNCT07540299
Dipotassium Oxalate for Postoperative Sensitivity in NCCLs
A study testing Dipotassium Oxalate Gel in people with Dentin Hypersensitivity, Post Operative Sensitivity Control, run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Dentin Hypersensitivity, Post Operative Sensitivity Control
- What is being tested?
- Dipotassium Oxalate Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Punjab Dental Hospital, Lahore
Lahore, Punjab Province, 54000
Dr. Shazia Naz, BDS, MDS, +923214614543, drshazianaz@demontmorency.edu.pk
osamasharif06@gmail.com
About this study
Official title: 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.
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.
- Being tested
- Dipotassium Oxalate Gel
- Keywords
- Dipotassium Oxalate, Postoperative Sensitivity, Composite Restoration, NCCL, Dentin Hypersensitivity
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dipotassium Oxalate GelCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Dipotassium oxalate pretreatment before composite restoration | Experimental | Participants receive dipotassium oxalate pretreatment before adhesive application and composite restoration. Receives: Combination Product: Dipotassium Oxalate Gel |
| No Dipotassium Oxalate Pre-treatment, Standard composite filling only | No intervention | Participants receive standard adhesive protocol without dipotassium oxalate pretreatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours, 7 days, and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin Hypersensitivity, Post Operative Sensitivity ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Application of dipotassium oxalate gel to dentin surface prior to adhesive placement in Class V composite restorations in Study group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Medical Institute, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Muhammad Usama Bin Sharif, Postgraduate Medical Institute, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540299
- Sponsor's protocol ID
- 2025-ERC-11
- Acronym
- DIPOX-RCT
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Dipotassium Oxalate in Postoperative Sensitivity Control in Class V Composite Restorations: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07540299
- Acronym / sponsor ID
- DIPOX-RCT / 2025-ERC-11
- Keywords
- Dipotassium Oxalate, Postoperative Sensitivity, Composite Restoration, NCCL, Dentin Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Postgraduate Medical Institute, LahoreUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Application of dipotassium oxalate gel to dentin surface prior to adhesive placement in Class V composite restorations in Study group
| Arm | Type | Receives |
|---|---|---|
| Dipotassium oxalate pretreatment before composite restoration | Experimental | Combination Product: Dipotassium Oxalate GelParticipants receive dipotassium oxalate pretreatment before adhesive application and composite restoration. |
| No Dipotassium Oxalate Pre-treatment, Standard composite filling only | No intervention | –Participants receive standard adhesive protocol without dipotassium oxalate pretreatment. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dipotassium Oxalate GelApplication 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. | Combination product | Dipotassium oxalate pretreatment before composite restoration |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Undecided. Confidentiality
Related trials for Dentin Hypersensitivity, Post Operative Sensitivity Control
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Gluma Compared With Bonding Agent for Post-operative Sensitivity Following Composite Restorations
Post-operative Sensitivity, Dentin Hypersensitivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dipotassium Oxalate Gel in people with Dentin Hypersensitivity, Post Operative Sensitivity Control, run by Postgraduate Medical Institute, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Usama Bin Sharif BIN SHARIF, BDS (+92 3124244476, osamasharif06@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Sensitivity (time frame: 24 hours, 7 days, and 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.