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

Primary Purpose

Dental Leakage

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Leakage

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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:

    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

    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.

Sites / Locations

  • Islam Ibrahim MohammedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Restoration with conventional no heated bulk-fill resin composite

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

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

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

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 13, 2022
Last Updated
February 25, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05383768
Brief Title
Clinical Evaluation of Preheated and Repeated Preheated Versus Conventional Bulk Fill Resin Composite
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Leakage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Restoration with conventional no heated bulk-fill resin composite
Arm Type
Placebo Comparator
Arm Description
Restoration with conventional no heated bulk-fill resin composite, X-tra fill (VOCO, GERMANY)
Arm Title
restoration with one-time preheated conventional bulk-fill resin composite
Arm Type
Active Comparator
Arm Description
restoration with one-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C
Arm Title
restoration with five-time preheated conventional bulk-fill resin composite
Arm Type
Active Comparator
Arm Description
restoration with five-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C
Arm Title
restoration with ten-time preheated conventional bulk-fill resin composite
Arm Type
Active Comparator
Arm Description
restoration with ten-time preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C
Intervention Type
Other
Intervention Name(s)
preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C
Intervention Description
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 Outcome Measure Information:
Title
(marginal integrity) using Modified US Public Health Service Criteria (USPHS)
Description
Clinical Evaluation of restoration (marginal integrity) using Modified US Public Health Service Criteria (USPHS)
Time Frame
one year
Secondary Outcome Measure Information:
Title
(Marginal discoloration, secondary caries and Postoperative Sensitivity) using Modified US Public Health Service Criteria (USPHS)
Description
Clinical Evaluation of restoration (Marginal discoloration, secondary caries and Postoperative Sensitivity) using Modified US Public Health Service Criteria (USPHS)
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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 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.
Facility Information:
Facility Name
Islam Ibrahim Mohammed
City
Cairo
ZIP/Postal Code
11865
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona IS Riad, Professor
Phone
002022364293
Email
monariad@dentistry.cu.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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