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Clinical Trials/NCT07212413
NCT07212413Active, not recruitingNot Applicable

Postoperative Sensitivity in Class II Restorations: A Randomized Clinical Trial Comparing Snow-Plow and Resin Coating Techniques

University of Jordan1 site in 1 country100 target enrollmentStarted: January 12, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
100
Locations
1
Primary Endpoint
Postoperative pain intensity after Class II composite restorations

Study Overview

Brief Summary

This study is designed to compare two modern techniques used to restore decayed back teeth with tooth-colored filling materials. Some patients experience temporary discomfort or sensitivity after these types of dental treatments. The purpose of this study is to learn whether one technique may help reduce this short-term sensitivity compared to the other.

Adults who need fillings on both sides of their mouth are invited to participate. Each patient will receive one filling using each technique, placed in different teeth during the same appointment. The procedures will be performed using standard clinical methods and materials.

After treatment, participants will be contacted by telephone to report any discomfort at several time points during the first week. The interviewer will not know which technique was used for each tooth to ensure unbiased reporting. This information will help dentists better understand how these techniques affect patients' comfort in the days following treatment.

Detailed Description

Postoperative tooth sensitivity is a common but often transient symptom following the placement of direct posterior resin composite restorations. Patients frequently report mild to moderate discomfort, particularly during the first few days after treatment, which can influence their perception of treatment success and overall satisfaction. While advances in adhesive dentistry and restorative materials have greatly improved clinical outcomes, postoperative sensitivity remains a relevant clinical concern.

This clinical trial is designed to compare two contemporary restorative techniques-the snow-plow technique and the resin coating technique following immediate dentin sealing-in terms of postoperative patient-reported pain during the first postoperative week. Both techniques aim to enhance marginal adaptation and reduce polymerization shrinkage stresses at the adhesive interface, thereby potentially minimizing pulpal irritation and postoperative discomfort.

Participants in this study are adult patients requiring Class II resin composite restorations on two comparable posterior teeth, typically located on opposite sides of the dental arch. Each participant will receive two restorations, one using the snow-plow technique and the other using the resin coating technique, in a split-mouth design. This approach allows each participant to serve as their own control, minimizing inter-patient variability and enabling a more reliable comparison between the two restorative strategies.

All procedures are performed under rubber dam isolation using standardized adhesive and restorative protocols to ensure clinical consistency. The snow-plow technique involves placing an uncured flowable bulk-fill resin on the cavity floor, immediately followed by the placement of a packable composite increment. Both materials are then light-cured simultaneously. This technique is intended to improve adaptation of the restorative material to cavity walls, displace voids, and reduce microleakage.

In the resin coating technique, immediate dentin sealing is performed following cavity preparation. A thin layer of flowable bulk-fill resin is then applied over the sealed dentin and light-cured before the placement of the final packable composite increment. This layer acts as a stress-absorbing liner, providing a flexible interface that may protect the pulp and reduce the transmission of shrinkage stresses during polymerization.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

The outcomes assessor was blinded to the restorative technique used on each tooth. Telephone interviews were conducted using standardized scripts, and the interviewer was unaware of the allocation, referring to teeth by quadrant/side to minimize bias. The operator is not blinded due to the nature of the restorative procedures.

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Adult patients aged 18-50 years.
  • •Systemically healthy individuals.
  • •Presence of two posterior teeth in different quadrants or contralateral sides of the same arch requiring Class II composite restorations.
  • •Teeth diagnosed with reversible pulpitis and vital pulps, confirmed clinically and radiographically.
  • •Teeth without previous restorations or carious lesions limited to dentin.
  • •Ability to provide informed consent and comply with study procedures and follow-up assessments.

Exclusion Criteria

  • •Non-vital teeth, teeth with signs of irreversible pulpitis, periapical pathology, or extensive loss of tooth structure.
  • •Patients with systemic conditions or medications that may influence pain perception, healing, or sensitivity (e.g., chronic pain syndromes, analgesic use, immunosuppressive therapy), or very poor oral hygiene.
  • •Pregnant or breastfeeding women.
  • •Known allergy to dental materials used in the study.
  • •Inability to respond to follow-up calls or provide reliable pain assessments.
  • •Teeth with previous restorations, endodontic treatment, or cracks.

Arms & Interventions

Snow-plow technique

Experimental

Class II posterior cavities were restored using the snow-plow technique. After adhesive application, a thin layer of uncured flowable bulk-fill resin was placed on the gingival floor. A packable bulk-fill composite was then immediately inserted, displacing the flowable resin, and both were light-cured simultaneously. The occlusal anatomy was completed with packable composite, followed by finishing and polishing. Rubber-dam isolation and selective enamel etching with a universal adhesive were applied in all cases.

Intervention: Snow-plow restorative technique (Procedure)

Resin coating technique

Experimental

Class II posterior cavities were restored using the resin coating technique following immediate dentin sealing. After adhesive application, a thin layer of flowable bulk-fill resin was applied and light-cured to create a stress-absorbing layer on the dentin surface. Packable bulk-fill composite was then used to restore the remaining cavity, followed by occlusal sculpting, finishing, and polishing. All procedures were performed under rubber-dam isolation with selective enamel etching and universal self-etch adhesive on dentin.

Intervention: Resin coating restorative technique (Procedure)

Outcomes

Primary Outcomes

Postoperative pain intensity after Class II composite restorations

Time Frame: Baseline, 24 hours, 72 hours, and 1 week after restorative treatment

Postoperative pain intensity will be assessed using a 0-10 Visual Analog Scale (VAS) at baseline (before treatment), 24 hours, 72 hours, and 1 week following restorative procedures. Each treated tooth will be evaluated individually using structured telephone interviews conducted by a blinded examiner. VAS scores will be recorded and analyzed to compare pain trajectories between the snow-plow and resin coating restorative techniques.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alaa Al-Haddad

Assisstant profossor in restorative dentistry

University of Jordan

Study Sites (1)

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