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
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.
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.
Exclusion Criteria:
Participants receive dipotassium oxalate pretreatment before adhesive application and composite restoration.
Combination Product: Dipotassium Oxalate Gel
Participants receive standard adhesive protocol without dipotassium oxalate pretreatment.
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.
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
Plan to share: Undecided — Confidentiality
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Postgraduate Medical Institute, Lahore