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

NCT05383768 | Completed DMC

• 1 other identifier: 20322
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Leakage

Outcome Measures

Primary Outcomes (1)

• (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 Outcomes (1)

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

  one year

Study Arms (4)

Restoration with conventional no heated bulk-fill resin composite

PLACEBO COMPARATOR

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

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

Interventions

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).

Restoration with conventional no heated bulk-fill resin composite; restoration with five-time preheated conventional bulk-fill resin composite; restoration with one-time preheated conventional bulk-fill resin composite; restoration with ten-time preheated conventional bulk-fill resin composite

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient age between (18-60) years old.
• Patient is capable of informed consent. 3-Patients with a high level of oral hygiene.
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• vital teeth
• Carious molar teeth.

You may not qualify if:

• 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.
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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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Islam Ibrahim Mohammed

Cairo, 11865, Egypt

Location

MeSH Terms

Conditions

Dental Leakage

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 20, 2022
• Study Start: March 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

EG (1)