Back to resultsThe Proximal Contact Tightness and Location in Class II Composite Restorations
Primary Purpose
Tooth Decay
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Precontoured sectional matrix EZ COAT
PerForm™
AdDent Trimax™
Contact Pro™
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Decay
Eligibility Criteria
Inclusion Criteria: Presence of proximal caries in CBCT x-ray with score 3 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS). Presence of the antagonist and the adjacent tooth making contact. The teeth to be restored had to show no signs of pulpitis but positive sensitivity using endo ice testing. Size of the isthmus with no more than 2/3 of the intercuspal distance Good oral health and absence of periodontal disease Patients who are not suffering from severe systemic diseases or allergies Exclusion Criteria: Medically compromised patients Clinical signs of bruxism, traumatic malocclusion Pregnant or breast feeding at the time of restoration placement Intolerance or allergy toward the applied restorative materials
Sites / Locations
- Karim Mohamed Wahba Abbass
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Palodent® plus sectional matrix system "Control group"
PerForm™ "Experimental"
Trimax™ "Experimental"
Contact Pro™ "Experimental"
Arm Description
Outcomes
Primary Outcome Measures
Change in proximal contact tightness
Proximal contact tightness (PCT) will be measured using the custom-made contact pressure system that was based on the tooth pressure meter, a device fabricated at the University of Technology, Delft, the Netherlands. (20) The system will use a 0.05-mm-thick metal strip inserted interdentally from An occlusal direction . The metal strip will be connected to the digital force gauge (Mark-10 series 2 digital force gauge). The tightness of the proximal contact will be quantified as the maximum frictional force when the strip will slowly removed in a buccal-lingual direction. The maximum force will be recorded on the screen of the gauge for each measurement when the gauge will be switched to peak-mode
Secondary Outcome Measures
Change in proximal contact location
calibration will be carried out by a radiologist, who evaluates the teeth carefully scrolling down through the images from the floor of the pulp chamber in all three orthogonal reconstructions (axial, coronal, and sagittal). To ensure image standardization, all cone-beam computed tomography (CBCT) images will be chosen from a single machine with a standard field of view, voxel size, exposure time and the thickness of the slice.
CBCT images will be analyzed with the built-in digital imaging software. The measurement tool will be used to determine the total length of the crown of the restored teeth, measured from the tip of the mesiobuccal cusp to the cementoenamel junction. Based on this length, the crown portion will be divided into three levels: coronal, middle and apical thirds.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05749640
Brief Title
The Proximal Contact Tightness and Location in Class II Composite Restorations
Official Title
Clinical Evaluation of the Proximal Contact Tightness and Location in Class II Composite Restoration Using Different Contact Forming Instruments
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
May 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
karim mohamed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to investigate consecutive biological changes in proximal contact tightness using digital force gauge and evaluate proximal contact location using cone beam computed tomography between class II direct composite restorations and adjacent teeth after using sectional matrix system and with different contact forming instruments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Decay
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will be a randomized control clinical trial in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines
Masking
ParticipantOutcomes Assessor
Masking Description
Each case will be represented by a code and the group name. These will be sealed in a sequentially numbered opaque envelope and the set of envelopes will be given to the senior supervisor. When the investigator wants to enroll a new case, he will notify the supervisor who will take the next inline envelope and will write the name of the participant on it. At the time of intervention implementation, the investigator will open the sealed envelope and retrieve the allocation and apply.
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Palodent® plus sectional matrix system "Control group"
Arm Type
Active Comparator
Arm Title
PerForm™ "Experimental"
Arm Type
Experimental
Arm Title
Trimax™ "Experimental"
Arm Type
Experimental
Arm Title
Contact Pro™ "Experimental"
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Precontoured sectional matrix EZ COAT
Intervention Description
All teeth will be treated with (Palodent ® plus sectional matrix system) (sectional matrix, biting ring, plastic diamond wedge)
Intervention Type
Other
Intervention Name(s)
PerForm™
Intervention Description
Treated with (PerForm™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)
Intervention Type
Other
Intervention Name(s)
AdDent Trimax™
Intervention Description
Treated with (AdDent Trimax™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)
Intervention Type
Other
Intervention Name(s)
Contact Pro™
Intervention Description
Treated with (Contact Pro™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)
Primary Outcome Measure Information:
Title
Change in proximal contact tightness
Description
Proximal contact tightness (PCT) will be measured using the custom-made contact pressure system that was based on the tooth pressure meter, a device fabricated at the University of Technology, Delft, the Netherlands. (20) The system will use a 0.05-mm-thick metal strip inserted interdentally from An occlusal direction . The metal strip will be connected to the digital force gauge (Mark-10 series 2 digital force gauge). The tightness of the proximal contact will be quantified as the maximum frictional force when the strip will slowly removed in a buccal-lingual direction. The maximum force will be recorded on the screen of the gauge for each measurement when the gauge will be switched to peak-mode
Time Frame
baseline, immediately postoperative, 1 month, 3 month, 9 month, and 12 month
Secondary Outcome Measure Information:
Title
Change in proximal contact location
Description
calibration will be carried out by a radiologist, who evaluates the teeth carefully scrolling down through the images from the floor of the pulp chamber in all three orthogonal reconstructions (axial, coronal, and sagittal). To ensure image standardization, all cone-beam computed tomography (CBCT) images will be chosen from a single machine with a standard field of view, voxel size, exposure time and the thickness of the slice.
CBCT images will be analyzed with the built-in digital imaging software. The measurement tool will be used to determine the total length of the crown of the restored teeth, measured from the tip of the mesiobuccal cusp to the cementoenamel junction. Based on this length, the crown portion will be divided into three levels: coronal, middle and apical thirds.
Time Frame
baseline and immediately postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of proximal caries in CBCT x-ray with score 3 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS).
Presence of the antagonist and the adjacent tooth making contact.
The teeth to be restored had to show no signs of pulpitis but positive sensitivity using endo ice testing.
Size of the isthmus with no more than 2/3 of the intercuspal distance
Good oral health and absence of periodontal disease
Patients who are not suffering from severe systemic diseases or allergies
Exclusion Criteria:
Medically compromised patients
Clinical signs of bruxism, traumatic malocclusion
Pregnant or breast feeding at the time of restoration placement
Intolerance or allergy toward the applied restorative materials
Facility Information:
Facility Name
Karim Mohamed Wahba Abbass
City
Alexandria
ZIP/Postal Code
00000
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Proximal Contact Tightness and Location in Class II Composite Restorations
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