NCT07212413

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
Last Updated

October 8, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

September 30, 2025

Last Update Submit

September 30, 2025

Conditions

Keywords

Postoperative sensitivityClass II composite restorationSnow-plow techniqueResin coating techniquePain assessment

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity after Class II composite restorations

    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.

    Baseline, 24 hours, 72 hours, and 1 week after restorative treatment

Study Arms (2)

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.

Procedure: Snow-plow restorative technique

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.

Procedure: Resin coating restorative technique

Interventions

The snow-plow technique involves placing a thin layer of uncured flowable bulk-fill resin on the gingival floor of a Class II cavity, immediately followed by placement of a packable bulk-fill composite. Both materials are light-cured simultaneously, allowing the flowable resin to fill voids and improve marginal adaptation.

Also known as: Snowplow technique
Snow-plow technique

The resin coating technique involves applying and light-curing a thin layer of flowable bulk-fill resin after adhesive application to create a stress-absorbing layer on dentin (resin coating), followed by restoration with packable bulk-fill composite. This approach aims to protect the dentin, enhance bond stability, and reduce postoperative sensitivity

Also known as: Resin coating, Immediate dentin sealing with flowable liner
Resin coating technique

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Jordan Hospital, Dental Department

Amman, Jordan

Location

Related Publications (6)

  • Afifi SMH, Haridy MF, Farid MR. Evaluation of Post-Operative Sensitivity of Bulk Fill Resin Composite versus Nano Resin Composite: A Randomized Controlled Clinical Study. Open Access Maced J Med Sci. 2019 Jul 26;7(14):2335-2342. doi: 10.3889/oamjms.2019.656. eCollection 2019 Jul 30.

    PMID: 31592052BACKGROUND
  • Lehmann A, Nijakowski K, Jankowski J, Donnermeyer D, Ramos JC, Drobac M, Martins JFB, Hatipoglu O, Omarova B, Javed MQ, Alharkan HM, Bekjanova O, Wyzga S, Alkhawas MAM, Kudenga R, Surdacka A. Clinical Difficulties Related to Direct Composite Restorations: A Multinational Survey. Int Dent J. 2025 Apr;75(2):797-806. doi: 10.1016/j.identj.2024.06.012. Epub 2024 Jul 23.

    PMID: 39048490BACKGROUND
  • Tee R, Vach K, Schlueter N, Jacker-Guhr S, Luehrs AK. High C-Factor Cavities: How Do "Snowplow Technique", Adhesive Application Mode and Aging Influence the Microtensile Bond Strength to Dentin? J Adhes Dent. 2024 Jan 15;26:1-10. doi: 10.3290/j.jad.b4835909.

    PMID: 38224111BACKGROUND
  • Putignano A, Tosco V, Monterubbianesi R, Vitiello F, Gatto ML, Furlani M, Giuliani A, Orsini G. Comparison of three different bulk-filling techniques for restoring class II cavities: muCT, SEM-EDS combined analyses for margins and internal fit assessments. J Mech Behav Biomed Mater. 2021 Dec;124:104812. doi: 10.1016/j.jmbbm.2021.104812. Epub 2021 Sep 3.

    PMID: 34500356BACKGROUND
  • Tardem C, Albuquerque EG, Lopes LS, Marins SS, Calazans FS, Poubel LA, Barcelos R, Barceleiro MO. Clinical time and postoperative sensitivity after use of bulk-fill (syringe and capsule) vs. incremental filling composites: a randomized clinical trial. Braz Oral Res. 2019 Sep 16;33(0):e089. doi: 10.1590/1807-3107bor-2019.vol33.0089.

    PMID: 31531552BACKGROUND
  • Miletic V, Komlenic V, Bajuk-Bogdanovic D, Stasic J, Petrovic V, Savic-Stankovic T. Preheating and "snow-plow" composite application technique affect double bond conversion but not bond strength to dentine. J Esthet Restor Dent. 2024 Jun;36(6):951-961. doi: 10.1111/jerd.13218. Epub 2024 Mar 18.

    PMID: 38497672BACKGROUND

Study Officials

  • Alaa Al-Haddad, PhD

    University of Jordan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: A randomized split-mouth clinical trial with two intervention arms (snow-plow and resin coating techniques) allocated to contralateral Class II cavities in the same patient. This crossover model minimizes inter-individual variability by enabling within-subject comparison under identical clinical conditions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant profossor in restorative dentistry

Study Record Dates

First Submitted

September 30, 2025

First Posted

October 8, 2025

Study Start

January 12, 2025

Primary Completion

September 24, 2025

Study Completion

October 6, 2025

Last Updated

October 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) underlying the results will be shared, including demographic data, intervention assignment, and all primary and secondary outcome measures. Data will be available to qualified researchers upon reasonable request following publication of the study results, in accordance with institutional and ethical guidelines. Supporting materials, such as the study protocol and statistical analysis plan, will also be provided.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations