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Clinical Evaluation of Different Resin Composite Restorations

Primary Purpose

Dental Caries

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring composite resin

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

inclusion criteria of participants:

  • Male gender
  • Good oral hygiene
  • Only Cooperative patient
  • Medically free patient
  • Age range 18-24

inclusion criteria of the teeth:

  • Vital teeth with no periapical lesion or radiolucency.
  • Prepared cavity with no undermined enamel walls.
  • Functioning tooth with presence of an opposing.
  • Healthy periodontium.

Exclusion Criteria:

  • exclusion criteria of participants:

    • Old age patients
    • Patients have systemic disease or sever medically compromised
    • Patients with bruxism, clenching or temporomandibular joint disorder.
    • Por oral hygiene

exclusion criteria of teeth:

  • Teeth with periapical lesions.
  • Teeth with visible cracks.
  • Teeth with mobility.
  • Non-functioning tooth with no opposing tooth.
  • Heavy occlusion or signs of sever attrition.
  • Tooth with Periodontal affection.

Sites / Locations

  • Faculty of dental medicine Al Azhar university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

bulkfill composites

incremental composites

Arm Description

sonic fill 3 & PALFIQUE bulk flow bulk fill composite

Neo spectra & Clear fill AP-X incremental composites

Outcomes

Primary Outcome Measures

Post operative sensitivity
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
marginal discoloration
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
marginal adaptation
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
recurrent caries
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)

Secondary Outcome Measures

Full Information

First Posted
June 5, 2022
Last Updated
September 27, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05418400
Brief Title
Clinical Evaluation of Different Resin Composite Restorations
Official Title
Comparative Study of Clinical Criteria of Different Resin Composite Restorations Among Lower Molars
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
October 2, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Posterior resin composite is challenging esthetic restoration. Patients seek for durable, esthetic and functional restorations in molars. one of the major problems is polymerization shrinkage. Some materials were developed to overcome the polymerization shrinkage, among them bulk fill resin composite which have been developed to reduce the shrinkage stress during polymerization and offer much greater depth of cure. This is achieved by the addition of fillers such as barium aluminum silicate filler, ytterbium trifluoride and mixed oxides. Furthermore, a prepolymerized fillers have been added with silanes to reduce shrinkage stress. so, the objective of this trial is to clinical Evaluate and compare clinical performance of bulk fill VS incremental filling technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
composite resin

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
bulkfill composites
Arm Type
Active Comparator
Arm Description
sonic fill 3 & PALFIQUE bulk flow bulk fill composite
Arm Title
incremental composites
Arm Type
Active Comparator
Arm Description
Neo spectra & Clear fill AP-X incremental composites
Intervention Type
Other
Intervention Name(s)
sonic fill 3 & PALFIQUE bulk flow & Neo spectra & Clear fill AP-X
Intervention Description
dental filling materials
Primary Outcome Measure Information:
Title
Post operative sensitivity
Description
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
Time Frame
along one year
Title
marginal discoloration
Description
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
Time Frame
along one year
Title
marginal adaptation
Description
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
Time Frame
along one year
Title
recurrent caries
Description
restorations will be evaluated the according to the modified United States Public Health Service (USPHS)
Time Frame
along one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: inclusion criteria of participants: Male gender Good oral hygiene Only Cooperative patient Medically free patient Age range 18-24 inclusion criteria of the teeth: Vital teeth with no periapical lesion or radiolucency. Prepared cavity with no undermined enamel walls. Functioning tooth with presence of an opposing. Healthy periodontium. Exclusion Criteria: exclusion criteria of participants: Old age patients Patients have systemic disease or sever medically compromised Patients with bruxism, clenching or temporomandibular joint disorder. Por oral hygiene exclusion criteria of teeth: Teeth with periapical lesions. Teeth with visible cracks. Teeth with mobility. Non-functioning tooth with no opposing tooth. Heavy occlusion or signs of sever attrition. Tooth with Periodontal affection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nady Ebrahem Hasanin, professor
Organizational Affiliation
Faculty of dental medicine Al Azhar university
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of dental medicine Al Azhar university
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Evaluation of Different Resin Composite Restorations

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