Dipotassium Oxalate for Postoperative Sensitivity in NCCLs
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-45
SponsorPostgraduate Medical Institute, Lahore
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Dipotassium Oxalate Gel
Combination productApplication 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.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Dipotassium oxalate pretreatment before composite restorationExperimental treatment 1 intervention
Group B: No Dipotassium Oxalate Pre-treatment, Standard composite filling onlyNo intervention 0 interventions
Trial outcomes
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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