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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05383768

Enrollment

Registered

2022-05-20

Start date

2022-03-01

Completion date

2023-04-01

Last updated

2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Leakage

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 .

Interventions

OTHERpreheated 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026