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NCT Number: NCT05383768

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

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.

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Key information

Conditions

Dental Leakage Stomatognathic Diseases Tooth Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Islam Ibrahim Mohammed

Cairo, 11865, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a)Inclusion Criteria of participants
  • Patient age between (18-60) years old.
  • Patient is capable of informed consent. 3-Patients with a high level of oral hygiene.

b)Inclusion Criteria of teeth:

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  • vital teeth
  • Carious molar teeth.

Exclusion criteria

  • a)Exclusion criteria of participants
  • Participants with general systematic illness.
  • Experience with allergic reactions against any component of used materials.
  • Concomitant participation in another research study.
  • Patients receiving Orthodontic treatment.
  • Pregnant or lactating females.
  • patient with heavy Bruxism habits.

b)Exclusion criteria of the teeth

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

Treatment and study plan

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

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).

Primary outcomes

  1. (marginal integrity) using Modified US Public Health Service Criteria (USPHS)

    Time frame: one year

    Clinical Evaluation of restoration (marginal integrity) using Modified US Public Health Service Criteria (USPHS)

Secondary outcomes

  1. (Marginal discoloration, secondary caries and Postoperative Sensitivity) using Modified US Public Health Service Criteria (USPHS)

    Time frame: one year

    Clinical Evaluation of restoration (Marginal discoloration, secondary caries and Postoperative Sensitivity) using Modified US Public Health Service Criteria (USPHS)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 20, 2022
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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