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

Cairo University (CU)

Status: Completed

Conditions: Dental Leakage

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05383768

20322

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 84 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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:

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  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

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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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 4 patient groups, including a placebo group

Restoration with conventional no heated bulk-fill resin composite

Placebo Comparator group

Description:

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

Treatment:

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

restoration with one-time preheated conventional bulk-fill resin composite

Active Comparator group

Description:

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

Treatment:

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

restoration with five-time preheated conventional bulk-fill resin composite

Active Comparator group

Description:

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

Treatment:

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

restoration with ten-time preheated conventional bulk-fill resin composite

Active Comparator group

Description:

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

Treatment:

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