Dipotassium Oxalate for Postoperative Sensitivity in NCCLs

NCT07540299 | Not Yet Recruiting DMC

• 1 other identifier: 2025-ERC-11
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dentin Hypersensitivity, Post Operative Sensitivity Control

Keywords

Dipotassium Oxalate; Postoperative Sensitivity; Composite Restoration; NCCL; Dentin Hypersensitivity

Outcome Measures

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.

  24 hours, 7 days, and 30 days

Study Arms (2)

Dipotassium oxalate pretreatment before composite restoration

EXPERIMENTAL

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

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.

Interventions

Dipotassium Oxalate Gel COMBINATION_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.

Dipotassium oxalate pretreatment before composite restoration

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Medical Institute, Lahore: lead

Study Sites (1)

Punjab Dental Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Muhammad Usama Bin Sharif BIN SHARIF, BDS

CONTACT

+92 3124244476; osamasharif06@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Application of dipotassium oxalate gel to dentin surface prior to adhesive placement in Class V composite restorations in Study group

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

PA (1)