Clinical trial NCT06485024: Effect of Modeling Resin on Anterior Direct Composite Veneer
Official title: Clinical Performance of Direct NanoHybrid Resin Composite Veneer Restorations Applied With or Without Modeling Resin:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Wear
Dental Decay
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the study will be conducted to evaluate the clinical performance of direct Nanohybrid resin composite veneer restorations applied with or without modeling resin

Detailed description: ChatGPT This study aims to investigate the impact of modeling resin on the clinical performance of direct nanohybrid resin composite veneer restorations in anterior teeth. Resin composites are widely used in dental restorations due to their aesthetic qualities, but issues like discoloration and surface roughness can affect their longevity and patient satisfaction. Modeling resin, used to aid in composite placement and sculpting, has become common, but concerns exist regarding its effects on composite properties, particularly long-term color stability.

The research will employ a randomized controlled trial design with a two-arm parallel approach. Adult patients (18-45 years) with anterior tooth defects suitable for composite veneer restoration will be recruited. The intervention group will receive nanohybrid resin composite with modeling resin, while the comparator group will receive the composite without modeling resin. Outcomes will be assessed using modified USPHS criteria, including color stability, color match, anatomical form, marginal adaptation, marginal discoloration, retention rate, presence of secondary caries, and postoperative sensitivity, at baseline and at follow-up intervals of 1, 3, 6, and 12 months.

Statistical analysis will involve independent t-tests for intergroup comparisons and repeated measures ANOVA for intragroup comparisons, with a significance level set at 0.05. The study aims to determine if the use of modeling resin influences the clinical outcomes of resin composite veneer restorations. Ethics approval will be obtained, and confidentiality of participant data will be strictly maintained throughout the study period.

Overall, this research seeks to provide insights into optimizing the application of resin composites in dental practice to enhance patient outcomes and satisfaction

Eligibility criteria: Inclusion Criteria:

* • Adults (18-45Ys) with anterior tooth defects indicated for direct composite veneer restoration.

  * Males or females.
  * Community-dwelling
  * Have all his/her anterior teeth with sufficient enamel structure
  * With ≥ 1 anterior tooth defect
  * Have sufficient cognitive ability to understand consent procedures
  * Anterior tooth defect indicated for direct composite veneer
  * Vital upper or lower anterior teeth with no signs or symptoms of irreversible pulpitis.
  * Mobility grade: no clinical mobility
  * Plaque index ≤ 2

Exclusion Criteria:

* Patients younger than 18 or older than 45 years old • Disabilities.
* Systemic diseases or severe medically compromised.
* Lack of compliance.
* Evidence of severe bruxism, clenching or temporomandibular joint disorders.
* Cognitive impairment

Periapical pathosis or signs of pulpal pathology.

* Malocclusion
* Possible prosthodontic restoration within 1 year.
* Non-vital tooth.
* Endodontically treated tooth.
* Severe periodontal affection or tooth indicated for extraction.

Primary outcomes:
measure: comparison of Color stability with and without the intervention
timeFrame: baseline and after one year
Secondary outcomes:
measure: comparing the effect of the intervention on color match
timeFrame: baseline and after one year
measure: comparing the effect of the intervention on anatomical form
timeFrame: baseline and after one year
measure: comparing the effect of the intervention on surface texture
timeFrame: baseline and after one year
measure: comparing the effect of the intervention on marginal adaptation
timeFrame: baseline and after one year
measure: comparing the effect of the intervention on marginal discoloration
timeFrame: baseline and after one year
measure: comparing the effect of the intervention on retention rate
timeFrame: baseline and after one year
measure: comparing the effect of the intervention on postoperative sensitivity
timeFrame: baseline and after one year
measure: comparing the effect of the intervention on recurrent caries
timeFrame: baseline and after one year
Other outcomes:
Locations:
Study officials:
References:
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