Clinical trial NCT06732115: Effect of One-step Versus Multistep Polishing Protocol on Class IV Composite Restorations.
Official title: Esthetic Performance and Surface Roughness of Class IV Nanohybrid Composite Restorations Following One-step Versus Multistep Polishing Protocol: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Esthetic Restorations
Keywords: Surface roughness
class IV
nanohybrid composite
multistep polishing system.
one-step polishing system
surface staining
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of various finishing and polishing techniques for composite resins used in dental restorations, with a focus on minimizing discoloration and surface roughness over time. Discoloration due to plaque accumulation and surface staining can lead to esthetic concerns, resulting in premature restoration replacement and increased costs. Prior research highlights that esthetic failures, such as color alterations and surface staining, are key reasons for the failure of anterior restorations. Given the contradictory findings in previous studies on finishing and polishing methods, this research seeks to determine whether one-step polishing system will have the same effect as the multistep system in terms of esthetic performance and surface roughness of nanohybrid resin composite class IV restorations. The main operator will compare between OneGloss (Shofu) the intervention and Super-Snap X-treme (Shofu) the comparator. Patients will be evaluated immediately following polishing then after 3 months, 6 months, and 12 months.


Eligibility criteria: Inclusion Criteria:

* Patient related criteria:

  * Patients with good general health.
  * Patients who agreed to the consent and committed to follow-up period
  * No specific age range.
  * Both genders.
  * Low and moderate caries risk patients
  * Normal occlusion
* Tooth related criteria

  * Fully erupted permanent anterior teeth with class IV.
  * Active caries, fractures, or defective Restorations in anterior teeth.

Exclusion Criteria:

* Patient related criteria

  * Patient with bad oral hygiene.
  * Patients with tetracycline or fluorosis staining.
  * Patients who could/would not participate in all times of follow-up.
  * Patients participating in more than 1 dental study.
  * Patient received fluoride varnish, or during orthodontic treatment.
  * Patients with tendency to do bleaching during the study.
  * Heavy Smokers
  * Patients who are alcoholic and addicted Tooth related criteria
  * Untreated periodontal disease was not allowed
  * Fully erupted anterior teeth with no defects

Primary outcomes:
measure: Surface Luster (success rate)
timeFrame: 24hours, 3 months, 6months and 12 months
Secondary outcomes:
measure: Surface Staining
timeFrame: 24hours, 3 months, 6months and 12 months
measure: Marginal Staining
timeFrame: 24hours, 3 months, 6months and 12 months
measure: Color Match
timeFrame: 24hours, 3 months, 6months and 12 months
measure: Surface Roughness
timeFrame: 24hours, 3 months, 6months and 12 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
state: Manial
Study officials:
References: