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

NCT ID: NCT05383768

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-04-01

Brief Summary

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.

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 .

Conditions

Dental Leakage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Restoration with conventional no heated bulk-fill resin composite

Restoration with conventional no heated bulk-fill resin composite, X-tra fill (VOCO, GERMANY)

Group Type: PLACEBO_COMPARATOR

preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C

Intervention Type: OTHER

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).

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

Group Type: ACTIVE_COMPARATOR

preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C

Intervention Type: OTHER

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).

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

Group Type: ACTIVE_COMPARATOR

preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C

Intervention Type: OTHER

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).

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

Group Type: ACTIVE_COMPARATOR

preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

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1. vital teeth

2. Carious molar teeth.

Exclusion Criteria

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.

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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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Islam Ibrahim Mohammed

Assisstant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Islam Ibrahim Mohammed

Cairo, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

20322

Identifier Type: -

Identifier Source: org_study_id