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Not yet recruiting Not applicable NCT07540299

Dipotassium Oxalate for Postoperative Sensitivity in NCCLs

No applicable phase (e.g. observational)
Conditions: Dentin Hypersensitivity, Post Operative Sensitivity Control

Sponsor: Postgraduate Medical Institute, Lahore

trial.available_in: БГ
Overview
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.
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
Who can participate
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.
Interventions
Dipotassium Oxalate Gel
COMBINATION_PRODUCT
Locations 1
Pakistan (1)
Punjab Dental Hospital, Lahore
Lahore , Punjab Province
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
30 Years
Maximum age
45 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
01.10.2026
Registry ID
NCT07540299
Source
clinicaltrials.gov
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