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

• Sponsor: Cairo University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05383768
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 6.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Leakage	Other: preheated conventional bulk-fill resin composite, X-tra fill (VOCO, GERMANY) at 68◦C	N/A

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 .

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Restoration with conventional no heated bulk-fill resin composite 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; 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).
Active Comparator: restoration with one-time preheated conventional bulk-fill resin composite 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; 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).
Active Comparator: restoration with five-time preheated conventional bulk-fill resin composite 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; 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).
Active Comparator: restoration with ten-time preheated conventional bulk-fill resin composite 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; 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).

Outcome Measures

Primary Outcome Measures

1. (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 Outcome Measures

1. (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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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)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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Islam Ibrahim Mohammed	Cairo		Egypt	11865

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Mar 1, 2022

More Information

Publications

None provided.

• Responsible Party: Islam Ibrahim Mohammed, Assisstant lecturer, Cairo University
• ClinicalTrials.gov Identifier: NCT05383768
• Other Study ID Numbers: 20322
• First Posted: May 20, 2022
• Last Update Posted: May 20, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dental Leakage

Study Results

No Results Posted as of May 20, 2022