Clinical Evaluation of Preheated and Repeated Preheated Versus Conventional Bulk Fill Resin Composite

Clinical Performance of Posterior Restorations of Bulk Fill Resin Composite Without Preheating Versus Repeated Preheating for One, Five and Ten Times: A Randomized Controlled Clinical Trial

A Randomized clinical trial to evaluate the clinical Performance of Posterior Restorations of Bulk Fill Resin Composite without Preheating Versus Repeated Preheating for One, Five and Ten times .The null hypothesis of this study is that there is no significant difference in clinical performance of the restoration during restoring posterior teeth when using bulk-fill without preheating and after repeated preheating for one , five and ten times in restoration of posterior teeth.

Study Overview

• Status: Completed
• Conditions: Dental Leakage
• Intervention / Treatment: Other: preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C

Detailed Description

Dental resin composites are widely used for adhesive restorative procedures nowadays due to the significant improvement in their physical and mechanical properties. However, volumetric shrinkage is still an inherent drawback of the polymerization of the resin matrix .

Preheating improves adaptation, polymerization shrinkage and degree of conversion without affect mechanical properties of resin composite restorations.

In clinical situation, composite resin syringe is repeatedly used for restoration of several cavities and if preheating is applied, this syringe will undergo several heating cycles so repeated preheating effect on composite resin should be tested.

Follow up Period will be 1 year , Evaluation will be done at 3,6,9 and 12 months .

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11865
    • Islam Ibrahim Mohammed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• a)Inclusion Criteria of participants

  1. Patient age between (18-60) years old.

  2. Patient is capable of informed consent. 3-Patients with a high level of oral hygiene.

     b)Inclusion Criteria of teeth:

  1. vital teeth
  2. Carious molar teeth.

Exclusion Criteria:

• a)Exclusion criteria of participants

  1. Participants with general systematic illness.
  2. Experience with allergic reactions against any component of used materials.
  3. Concomitant participation in another research study.
  4. Patients receiving Orthodontic treatment.
  5. Pregnant or lactating females.

  6. patient with heavy Bruxism habits.

     b)Exclusion criteria of the teeth

  1. The tooth to be filled is an abutment tooth for a removable prosthesis.
  2. The tooth to be filled is periodontally involved (grade 2 or grade 3 mobile).
  3. Endodontically treated tooth.
  4. tooth with previous restoration
  5. Exposed tooth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Restoration with conventional no heated bulk-fill resin composite; Restoration with conventional no heated bulk-fill resin composite, X-tra fill (VOCO, GERMANY)	Other: preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C; Intervention 1: restoration with one-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020). Intervention 2: Restoration with five time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020). Intervention 3: Restoration with ten time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020).
Active Comparator: restoration with one-time preheated conventional bulk-fill resin composite; restoration with one-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C	Other: preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C; Intervention 1: restoration with one-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020). Intervention 2: Restoration with five time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020). Intervention 3: Restoration with ten time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020).
Active Comparator: restoration with five-time preheated conventional bulk-fill resin composite; restoration with five-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C	Other: preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C; Intervention 1: restoration with one-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020). Intervention 2: Restoration with five time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020). Intervention 3: Restoration with ten time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020).
Active Comparator: restoration with ten-time preheated conventional bulk-fill resin composite; restoration with ten-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C	Other: preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C; Intervention 1: restoration with one-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020). Intervention 2: Restoration with five time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020). Intervention 3: Restoration with ten time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C (Yang et al., 2020).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(marginal integrity) using Modified US Public Health Service Criteria (USPHS)	Clinical Evaluation of restoration (marginal integrity) using Modified US Public Health Service Criteria (USPHS)	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Marginal discoloration, secondary caries and Postoperative Sensitivity) using Modified US Public Health Service Criteria (USPHS)	Clinical Evaluation of restoration (Marginal discoloration, secondary caries and Postoperative Sensitivity) using Modified US Public Health Service Criteria (USPHS)	one year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: May 13, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2024
• Last Update Submitted That Met QC Criteria: May 26, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Leakage
• Other Study ID Numbers: 20322

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No