- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07415317
Influence of Composite Placement Techniques on the Clinical Performance of Posterior Restorations in Vital Teeth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Because of their conservative nature, aesthetic qualities, and consistently improved mechanical performance and handling features, resin-based composites have become the restorative material of choice for posterior teeth. Nevertheless, significant obstacles influencing the stability of the marginal area, sensitivity following the procedure, and the durability and effectiveness of composite restorations in the long run are polymerization shrinkage and stress associated with shrinkage.
To reduce polymerization stress and maximize adaptability to hollow walls, various placement procedures have been suggested. While older incremental layering methods sought to lessen the configuration factor (C-factor) and increase light penetration, more recent methods like the Stamp and Snowplow approaches sought to replicate the occlusal architecture and enhance marginal sealing. Conversely, bulk-fill techniques were first developed to streamline clinical processes by enabling the use of bigger composite layers with the promise of lower shrinkage stress.
Despite a plethora of in vitro studies, there is a dearth of high-quality clinical data that compares these placement methods under controlled settings. Due to the fact that laboratory studies cannot completely replicate the oral environment, clinical trials continue to be the best way to assess the real-world efficacy of restorative procedures.
Consequently, this randomized clinical trial set out to assess the clinical efficacy of posterior composite restorations placed in vital teeth utilizing four distinct procedures over the course of a year
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tanta, Egypt
- Faculty of Dentistry
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Tanta
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Tanta, Tanta, Egypt
- Restorative Department, Faculty of Dentistry, Tanta University
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Tanta, Tanta, Egypt, 31527
- Restorative Department, Faculty of Dentistry, Tanta University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Good general and oral health
- Vital posterior teeth with primary occlusal caries
- Class I cavities with depth ranging from 3 to 4 mm
Exclusion Criteria:
- Non-vital or restored teeth
- Parafunctional habits (e.g., bruxism)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: incremental nanohybrid composite
Stamp technique
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Fifty patients received a total of 200 Class I composite restorations, which were placed using the same nanohybrid composite resin and randomly allocated into four groups (n = 50) according to placement technique: Group I-Stamp technique; Group II-Snowplow technique; Group III-Modified incremental "Pizza" technique; and Group IV-Bulk-fill technique
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Experimental: Flowable and nanohybrid composite
Snowplow technique
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Fifty patients received a total of 200 Class I composite restorations, which were placed using the same nanohybrid composite resin and randomly allocated into four groups (n = 50) according to placement technique: Group I-Stamp technique; Group II-Snowplow technique; Group III-Modified incremental "Pizza" technique; and Group IV-Bulk-fill technique
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Experimental: incremental layering technique
Modified incremental "Pizza" technique
|
Fifty patients received a total of 200 Class I composite restorations, which were placed using the same nanohybrid composite resin and randomly allocated into four groups (n = 50) according to placement technique: Group I-Stamp technique; Group II-Snowplow technique; Group III-Modified incremental "Pizza" technique; and Group IV-Bulk-fill technique
|
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Experimental: bulk fill composite resin
Bulk-fill technique
|
Fifty patients received a total of 200 Class I composite restorations, which were placed using the same nanohybrid composite resin and randomly allocated into four groups (n = 50) according to placement technique: Group I-Stamp technique; Group II-Snowplow technique; Group III-Modified incremental "Pizza" technique; and Group IV-Bulk-fill technique
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The primary outcome was marginal adaptation
Time Frame: 24 months
|
Clinical evaluation of marginal adaptation was performed according to the World Dental Federation (FDI) by two calibrated evaluators at baseline and at 6, 12, and 24 months. All of the restorations were ranked according to how well they met the criteria: score 1 (clinically excellent), score 2 (clinically satisfactory), score 3 (clinically satisfactory), or scores 4 and 5 (clinically inadequate). Clinical success was defined as a score of 1, 2, or 3, and failure was indicated by scores of 4 or 5. A powerful light source was used to conduct the visual inspection of the parameters. A magnifying dental loupe was utilized for this purpose. The Friedman test was conducted to evaluate intragroup comparisons of the same restoration outcomes through different follow-up periods. The Kruskal-Wallis test was utilized to assess intergroup comparisons between different restorations during the same follow-up period. Time Frame: 24 months |
24 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Karunakar P, Ranga Reddy MS, Kumar BS, Namratha R. Direct and indirect stamp techniques for composite restorations - Sealing the uniqueness of a tooth: A case series. J Conserv Dent. 2022 May-Jun;25(3):327-331. doi: 10.4103/jcd.jcd_616_21. Epub 2022 Jun 13.
- Paolone G, Coccoluto L, Cortili S, Collivasone G, Cantatore G, Gherlone EF. Copolymerizing flowable and high-viscosity composite resins in class II restorations: The "Snowplow" technique. A scoping review. J Prosthet Dent. 2025 Nov 14:S0022-3913(25)00863-7. doi: 10.1016/j.prosdent.2025.10.058. Online ahead of print.
- Zhu J, Fu C, Deng X, Ma L, Song F, Huang C. Effects of stamp material and restoration depth on the accuracy of direct composite resin restorations using stamp technique. J Dent. 2024 Nov;150:105369. doi: 10.1016/j.jdent.2024.105369. Epub 2024 Sep 26.
- Vertuan M, Mosquim V, Guimaraes GMF, Obeid AT, Bombonatti JFS, Ishikiriama SK, Furuse AY. The stamp technique for direct restoration in a ICDAS 4 carious lesion: A 4-year follow-up. J Esthet Restor Dent. 2023 Apr;35(3):442-448. doi: 10.1111/jerd.12963. Epub 2022 Sep 26.
- Desai D. "Stamp" Technique to Recreate Accurate Occlusal Topography for Direct Composite Posterior Restorations. Compend Contin Educ Dent. 2025 May;46(5):236-239.
- Zotti F, Vincenzi S, Zangani A, Bernardi P, Sbarbati A. Stamp Technique: An Explorative SEM Analysis. Dent J (Basel). 2023 Mar 8;11(3):77. doi: 10.3390/dj11030077.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Composite Placement Techniques
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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